2,492 results on '"Clobazam"'
Search Results
2. Pharmacokinetics, Pharmacodynamics, and Safety Profile of Understudied Drugs Administered to Children Per Standard of Care (POPS) (POPS or POP02)
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The Emmes Company, LLC and Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)
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- 2024
3. Utilizing an acute hyperthermia‐induced seizure test and pharmacokinetic studies to establish optimal dosing regimens in a mouse model of Dravet syndrome.
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Mensah, Jeffrey A., Johnson, Kristina, Freeman, Tia, Reilly, Christopher A., Rower, Joseph E., Metcalf, Cameron S., and Wilcox, Karen S.
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VALPROIC acid , *CLOBAZAM , *CANNABIDIOL , *MASS spectrometry , *LABORATORY mice - Abstract
Objective: The current standard of care for Dravet syndrome (DS) includes polytherapy after inadequate seizure control with one or more monotherapy approaches. Treatment guidelines are often based on expert opinions, and finding an optimal balance between seizure control and adverse drug effects can be challenging. This study utilizes the efficacy and pharmacokinetic assessment of a second‐line treatment regimen that combines clobazam and sodium valproate with an add‐on drug as a proof‐of‐principle approach to establish an effective therapeutic regimen in a DS mouse model. Methods: We evaluated the efficacy of add‐on therapies stiripentol, cannabidiol, lorcaserin, or fenfluramine added to clobazam and sodium valproate against hyperthermia‐induced seizures in Scn1aA1783V/WT mice. Clobazam, N‐desmethyl clobazam (an active metabolite of clobazam), sodium valproate, stiripentol, and cannabidiol concentrations were quantified in plasma and brain using liquid chromatography–tandem mass spectrometry for the combinations deemed effective against hyperthermia‐induced seizures. The concentration data were used to calculate pharmacokinetic parameters via noncompartmental analysis in Phoenix WinNonLin. Results: Higher doses of stiripentol or cannabidiol, in combination with clobazam and sodium valproate, were effective against hyperthermia‐induced seizures in Scn1aA1783V/WT mice. In Scn1aWT/WT mice, brain clobazam and N‐desmethyl clobazam concentrations were higher in the triple‐drug combinations than in the clobazam monotherapy. Stiripentol and cannabidiol brain concentrations were greater in the triple‐drug therapy than when given alone. Significance: A polypharmacy strategy may be a practical preclinical approach to identifying efficacious compounds for DS. The drug–drug interactions between compounds used in this study may explain the potentiated efficacy of some polytherapies. [ABSTRACT FROM AUTHOR]
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- 2024
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4. Adjunctive cenobamate in people with focal onset seizures: Insights from the Italian Expanded Access Program.
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Roberti, Roberta, Assenza, Giovanni, Bisulli, Francesca, Boero, Giovanni, Canafoglia, Laura, Chiesa, Valentina, Di Bonaventura, Carlo, Di Gennaro, Giancarlo, Elia, Maurizio, Ferlazzo, Edoardo, Giordano, Alfonso, La Neve, Angela, Liguori, Claudio, Meletti, Stefano, Operto, Francesca Felicia, Pietrafusa, Nicola, Puligheddu, Monica, Pulitano, Patrizia, Rosati, Eleonora, and Sammarra, Ilaria
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SODIUM channel blockers , *SEIZURES (Medicine) , *PARTIAL epilepsy , *DRUG interactions , *CLOBAZAM - Abstract
Objective: This study was undertaken to assess the effectiveness/tolerability of adjunctive cenobamate, variations in the load of concomitant antiseizure medications (ASMs) and predictors of clinical response in people with focal epilepsy. Methods: This was a retrospective study at 21 centers participating in the Italian Expanded Access Program. Effectiveness outcomes included retention and responder rates (≥50% and 100% reduction in baseline seizure frequency). Tolerability/safety outcomes included the rate of treatment discontinuation due to adverse events (AEs) and their incidence. Total drug load was quantified as the number of concomitant ASMs and total defined daily dose (DDD). Concomitant ASMs were also classified according to their mechanism of action and pharmacokinetic interactions to perform explorative subgroup analyses. Results: A total of 236 subjects with a median age of 38 (Q1–Q3 = 27–49) years were included. At 12 months, cenobamate retention rate was 78.8% and responders were 57.5%. The seizure freedom rates during the preceding 3 months were 9.8%, 12.2%, 16.3%, and 14.0% at 3, 6, 9, and 12 months. A higher percentage of responders was observed among subjects treated with clobazam, although the difference was not statistically significant. A total of 223 AEs were recorded in 133 of 236 participants, leading to cenobamate discontinuation in 8.5% cases. At 12 months, a reduction of one or two concomitant ASMs occurred in 42.6% and 4.3% of the subjects. The median total DDD of all concomitant ASMs decreased from 3.34 (Q1–Q3 = 2.50–4.47) at baseline to 2.50 (Q1–Q3 = 1.67–3.50) at 12 months (p <.001, median percentage reduction = 22.2%). The highest rates of cotreatment withdrawal and reductions in the DDD were observed for sodium channel blockers and γ‐aminobutyric acidergic modulators (above all for those linked to pharmacokinetic interactions), and perampanel. Significance: Adjunctive cenobamate was associated with a reduction in seizure frequency and in the burden of concomitant ASMs in adults with difficult‐to‐treat focal epilepsy. The type of ASM associated did not influence effectiveness except for a favorable trend with clobazam. [ABSTRACT FROM AUTHOR]
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- 2024
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5. Spectrophotometric quantification of trace levels of cyanide in water-insoluble drug substances and confirmation of specificity through an orthogonal comparison approach.
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Srinivas, Torati, Suresh Reddy, K.V.N., Ramul, Sigilipalli, and Kiranmai Reddy, M.
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HYDROPHILIC compounds ,CYANIDES ,CLOBAZAM ,MASS spectrometry ,REGULATORY compliance - Abstract
Some pharmaceutical ingredients use cyanide in their synthesis, and this impurity must be controlled as per ICH, FDA and EDQM regulatory compliance. Spectrophotometric approaches for measuring cyanide levels are confined to water or water-soluble compounds with poor solution stability and low sensitivity. No method is available for the cyanide in water-insoluble drug substances through spectrophotometry. To address this gap, our study proposed a spectrophotometric approach for measuring trace cyanide in water-insoluble drugs such as Primidone and Clobazam. This method utilizes chloramine-T, which reacts with cyanide to form cyanogen chloride (CNCl), consequently reacting with pyridine-barbituric acid to produce a coloured derivative (C
13 H10 N4 O6 , MW: 318.06 g/mol). This protocol also involves the selection of a suitable solvent and optimizing the pH for sensitive/accurate quantification of cyanide impurity. Mass spectrometry confirms cyanide derivatization as part of the orthogonal procedure comparison of ICH Q2 (R2). Method validation follows ICH Q2 (R2) guidelines in determining specificity, LOD (0.396 ppm), LOQ (1.200 ppm), linearity (1.2-45 ppm), and recovery (91-99% with %RSD<10%) of the method. The stability of the pyridine-barbituric acid reagent and derivatized compound was also evaluated. This approach effectively measures cyanide in water-insoluble drugs, meeting essential regulatory standards. [ABSTRACT FROM AUTHOR]- Published
- 2024
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6. Sindromul Dravet-caz clinic.
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Istratuc, Irina, Căpestru, Elena, Calistru, Iulia, Constantin, Olga, Sprîncean, Mariana, Calcîi, Cornelia, Groppa, St., and Hadjiu, Svetlana
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FEBRILE seizures , *VALPROIC acid , *SODIUM channels , *STATUS epilepticus , *CLOBAZAM - Abstract
Introduction: Dravet Syndrome (DS) is a developmental and epileptic encephalopathy (EE) that typically begins in the first year of life. It's initial manifestation usually presents as a prolonged seizure (lasting more than five minutes) triggered by high fever. The incidence rate of Dravet Syndrome is estimated to be 1 in 15,700, with the majority of patients having a mutation in the SCN1A sodium channel gene. Objective: To elucidate the characteristics of Dravet Syndrome through the analysis of a clinical case. Materials and Methods: A child who was admitted repeatedly in the Neurology Department with complaints of complex febrile seizures (CFS) and status epilepticus (SE) exacerbated by fever was evaluated. The child underwent clinical-neurological, electroencephalographic (EEG), and molecular- genetic examinations. Results: The seizures occurred during fever, lasting more than 10 minutes and more than 30 minutes. The onset was at the age of 4 months, and by the age of 1 year, the child presented with CFS and SE with each fever. At the age of 1 year, the child also experienced other types of seizures- atonic, focal (left hand clonus, oral and ocular automatisms) in an afebrile context. Pathological signs included diffuse hypotonia. The initial EEG was within normal limits, but after 18 months, EEG anomalies during sleep appeared (focal activity in the left fronto-temporal cortical areas). Whole-exome sequencing revealed a mutation in the SCN1A gene. The diagnosis was Developmental and Epileptic Encephalopathy, Dravet Syndrome. The treatment plan included Valproic Acid, Clobazam, and Stiripentol. Conclusions: Dravet Syndrome is a severe EE, difficult to recognize at the onset. Early recognition and diagnosis of Dravet Syndrome contribute to the administration of targeted anticonvulsant medications, which can improve the child's long-term neurodevelopmental outcome [ABSTRACT FROM AUTHOR]
- Published
- 2024
7. Impact of Age and Concurrent Antiseizure Medication Use on Lacosamide Dose to Concentration Ratio and Dosing in Pediatric Patients.
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Woods, Megan, Phelps, Stephanie J., Christensen, Michael L., Meibohm, Bernd, and Wheless, James W.
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CHILD patients , *AGE groups , *DRUG interactions , *CLOBAZAM , *VIMPAT - Abstract
OBJECTIVE To evaluate age, adjunctive antiseizure medication (ASM), and specific ASMs on lacosamide (LCM) weight normalized dose-to-concentration ratio (DCR) and US Food and Drug Administration (FDA) dosing guidelines in pediatric patients. METHODS Patients 1 mo to ≤18 years with a LCM serum concentration between October 2009 and June 2017 were considered. Demographics, LCM DCR, and adjunctive ASM were recorded. LCM DCR/hr was used as a surrogate for clearance. Data were stratified by age (1 mo-< 2 yr; ≥ 2–6 yr; ≥ 6–12 yr; and ≥12–≤18 yr), FDA dosing weights, and ASM potential to interaction with LCM. RESULTS There were 646 sera (380 patients) with median dose 8.36 mg/kg/day (IQR, 5.92–11.16). 50.2% of doses were within FDA-weight guidelines; however, 40.4% exceeded recommendations. Most (81.3%) LCM concentrations were between 2 and 12 mg/L. A difference existed in DCR between ages, with those <2 years having the highest DCR (p < 0.001). Moving across age groups, the DCR decreases by 30.7%, 50.5%, and 63.4%. There was a weak (r2 = 0.073) but significant (p < 0.001) negative correlation between DCR and age. 84.8% received adjunctive ASM consisting of at least one of 31 different ASMs. DCR was higher with adjunctive ASMs compared with monotherapy [0.061 (0.039–0.095) vs 0.043 (0.030–0.062)], respectively (p < 0.001) and was greatest with inducers. Phenobarbital increased DCR by 2.6-fold, topiramate by 72.1%, and clobazam by 32.6%. Inhibitors had no effect. CONCLUSIONS The correlation between age and DCR was weak, accounting for 6% of variability. Strong inducers significantly increased DCR. Synergy may exist when multiple inducers are given. Weak inhibitors did not affect DCR. Those ≥6 to 11 kg, ≥30 to 50 kg, and those given strong inducers may require larger initial LCM doses. Serum concentrations should be used to individualize dosing, especially in those receiving strong inducers. [ABSTRACT FROM AUTHOR]
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- 2024
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8. Advancements in Dravet Syndrome Therapeutics: A Comprehensive Look at Present and Future Treatment Horizons: A Focused Review.
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Mahesan, Aakash, Kamila, Gautam, and Gulati, Sheffali
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GENE therapy , *CANNABIDIOL , *VAGUS nerve , *KETOGENIC diet , *SEROTONIN uptake inhibitors , *NUCLEOTIDES , *VALPROIC acid , *DRAVET syndrome , *NEURAL stimulation , *ANTICONVULSANTS , *CLOBAZAM - Abstract
Dravet syndrome (DS) is a developmental epileptic encephalopathy, characterized by fever-triggered focal or hemiclonic seizures at onset with various associated comorbidities like intellectual disability, gait abnormalities, and behavioral issues. It typically advances to drug-refractory epilepsy with multiple seizure semiology. In this review, we give a focused narrative on the treatment aspects of DS. We searched the PubMed database for articles on DS. More than 500 articles were reviewed, of which 55 relevant articles are included in this review. ClinicalTrials.gov database was also accessed for data on ongoing trials. Majority are caused by mutations in the SCN1A gene. Valproate and clobazam are the most commonly used traditional antiseizure medications. Stiripentol, fenfluramine, and cannabidiol are recently approved drugs with promising results. Ketogenic diet and vagus nerve stimulation are commonly tried nonpharmacologic modalities that have shown significant responses. Antisense oligonucleotides and viral vector-mediated gene transfer therapies are on the horizon. This review outlines the current existing treatment rationale, evidence for newly approved drugs, and the future scope of gene therapy in DS. [ABSTRACT FROM AUTHOR]
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- 2024
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9. Physician Approaches to the Pharmacologic Treatment of Dystonia in Cerebral Palsy.
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Lott, Emma, Fehlings, Darcy, Gelineau-Morel, Rose, Kruer, Michael, Mink, Jonathan W., Thomas, Sruthi P., Wisniewski, Steve, and Aravamuthan, Bhooma
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DRUG dosage , *BACLOFEN , *HETEROCYCLIC compounds , *CANNABIDIOL , *DIAZEPAM , *RESEARCH funding , *PIPERIDINE , *METHYLDOPA , *CLONIDINE , *CEREBRAL palsy , *DESCRIPTIVE statistics , *DECISION making in clinical medicine , *SEVERITY of illness index , *FUNCTIONAL status , *PHYSICIANS' attitudes , *INJECTIONS , *SPASTICITY , *DYSTONIA , *PHYSICIAN practice patterns , *GABAPENTIN , *DRUG efficacy , *PAIN , *RETENTION of urine , *PHYSICIANS , *DRUG prescribing , *DRUGS , *CLONAZEPAM , *DRUG utilization , *DOPA , *CLOBAZAM , *CONSTIPATION , *DISEASE complications - Abstract
The article discusses research which investigated physician approaches to the pharmacologic dystonia treatment in people with cerebral palsy. The study surveyed physician approaches regarding medications for dystonia in CP including baclofen, trihexyphenidyl, gabapentin, carbidopa/levodopa, clonazepam, diazepam, clonidine, tetrabenazine, clobazam and cannabidiol. It described physician's prescribing practices and choice of medications for dystonia.
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- 2024
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10. Prophylactic antiseizure medications for recurrent status epilepticus in nonsyndromic childhood epilepsy.
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Takeuchi, Hirokazu, Higurashi, Norimichi, and Toga, Yurika
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CHILDHOOD epilepsy , *STATUS epilepticus , *PHENOBARBITAL , *DRUGS , *BRAIN injuries , *CLOBAZAM - Abstract
The management of status epilepticus (SE) has mainly focused on the termination of ongoing SE episodes. However, long-term therapeutic strategies for the prevention of SE are lacking. This study aimed to investigate the effectiveness of prophylactic antiseizure medications (ASMs) for SEs in nonsyndromic childhood epilepsy. This retrospective study was conducted at Jikei University Hospital. Patients <18 years of age, diagnosed with epilepsy, and experiencing three or more SE episodes within 1 year between April 1, 2017, and October 1, 2021, were included. ASMs introduced for seizure types that developed into SE were evaluated. The effectiveness of ASMs was determined by using the "Rule of Three": An ASM was determined effective if patients were free of SE for a duration at least three times that of their longest SE interval in 12 months prior to intervention. The investigation included a total of 32 ASMs administered to 13 patients. The longest interval between SE episodes before ASM administration was 28–257 d. The first SE interval after ASM administration was 12–797 d. Levetiracetam (LEV) and clobazam (CLB) showed effectiveness in 2/10 and 5/6 patients, respectively. Other ASMs were ineffective. The leading etiology of epilepsy was perinatal brain injury, identified in four patients, and CLB was effective in all of them. The present study suggests that CLB and LEV may prolong the SE interval in some cases of nonsyndromic childhood epilepsy. CLB may be beneficial, particularly in patients with perinatal brain injury. [ABSTRACT FROM AUTHOR]
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- 2024
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11. GABA Pathways in Autism Spectrum Disorder (ASD)
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Dr Grainne McAlonan, Professor
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- 2023
12. Advances in the Adjunctive Treatment of Lennox-Gastaut Syndrome with Clobazam and Cannabidiol
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SHI Jingtian, CHEN Chaoyang, YANG Ting, WEI Ran, ZHANG Xuanling, WANG Zining, HU Xiaojuan, and ZHOU Ying
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rare diseases ,lennox-gastaut syndrome ,clobazam ,cannabidiol ,orplan drugs ,Medicine - Abstract
Lennox-Gastaut syndrome (LGS) is a severe, epileptic encephalopathy.In recent years, a variety of drugs have been approved for the treatment of LGS. The U.S. Food and Drug Administration approved clobazam and cannabidiol as adjunctive therapy for LGS in October 2011 and June 2018, respectively. This article provides an overview of clobazam and cannabidiol, including their chemical structures, pharmacological actions, curative effects, safety profile, drug interactions, to introduce the current state of research and the achievements of both drugs.
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- 2024
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13. A computational clinical decision-supporting system to suggest effective anti-epileptic drugs for pediatric epilepsy patients based on deep learning models using patient's medical history.
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Cho, Daeahn, Yu, Myeong-Sang, Shin, Jeongyoon, Lee, Jingyu, Kim, Yubin, Kang, Hoon-Chul, Kim, Se Hee, and Na, Dokyun
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CHILD patients , *PEOPLE with epilepsy , *CONVOLUTIONAL neural networks , *ANTICONVULSANTS , *DEEP learning , *CLOBAZAM - Abstract
Background: Epilepsy, a chronic brain disorder characterized by abnormal brain activity that causes seizures and other symptoms, is typically treated using anti-epileptic drugs (AEDs) as the first-line therapy. However, due to the variations in their modes of action, identification of effective AEDs often relies on ad hoc trials, which is particularly challenging for pediatric patients. Thus, there is significant value in computational methods capable of assisting in the selection of AEDs, aiming to minimize unnecessary medication and improve treatment efficacy. Results: In this study, we collected 7,507 medical records from 1,000 pediatric epilepsy patients and developed a computational clinical decision-supporting system for AED selection. This system leverages three multi-channel convolutional neural network (CNN) models tailored to three specific AEDs (vigabatrin, prednisolone, and clobazam). Each CNN model predicts whether a respective AED is effective on a given patient or not. The CNN models showed AUROCs of 0.90, 0.80, and 0.92 in 10-fold cross-validation, respectively. Evaluation on a hold-out test dataset further revealed positive predictive values (PPVs) of 0.92, 0.97, and 0.91 for the three respective CNN models, representing that suggested AEDs by our models would be effective in controlling epilepsy with a high accuracy and thereby reducing unnecessary medications for pediatric patients. Conclusion: Our CNN models in the system demonstrated high PPVs for the three AEDs, which signifies the potential of our approach to support the clinical decision-making by assisting doctors in recommending effective AEDs within the three AEDs for patients based on their medical history. This would result in a reduction in the number of unnecessary ad hoc attempts to find an effective AED for pediatric epilepsy patients. [ABSTRACT FROM AUTHOR]
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- 2024
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14. Evaluation of potential drug–drug interactions with medical cannabis.
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Ho, Jessie Jia Yi, Goh, Chenyi, Leong, Caitlin Shen Ai, Ng, Khuen Yen, and Bakhtiar, Athirah
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DRUG interactions , *TERMINATION of treatment , *CANNABIS (Genus) , *MEDICAL marijuana , *CYTOCHROME P-450 , *CLOBAZAM , *ANTICONVULSANTS - Abstract
Cannabis–drug interactions have caused significant concerns, mainly due to their role in the cytochrome P450 (CYP) enzyme‐mediated metabolic pathway of numerous medications. A systematic review was conducted to gain an overview of the potential interactions of cannabis with different drug classes by extracting pertinent information from published study data. From the inception of the study to October 1, 2023, we performed a systematic search of PubMed, Scopus, clinicaltrials.gov, and Web of Science. We included 54 out of 464 articles, and a total of 20 drug classes were identified to have interactions with medicinal cannabis. The cannabis–drug interactions were assessed and classified according to their probability and severity. The analysis revealed that antiepileptics had the most evidence of interaction with cannabis, followed by clobazam (CLB), warfarin, and tacrolimus. Generally, cannabis–drug interactions result in pharmacokinetic (PK) or pharmacodynamic (PD) changes. Therefore, careful monitoring should be performed to detect any unusual elevations in plasma levels. In addition, dose titrations or treatment withdrawal could help mitigate the adverse effects attributed to cannabis–drug interactions. Nevertheless, novel drugs are constantly emerging, and more research is needed to further identify potential interactions with cannabis. [ABSTRACT FROM AUTHOR]
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- 2024
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15. Long‐term benzodiazepine usage and mortality in patients with chronic non‐cancer musculoskeletal pain: A Nationwide cohort study.
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Oh, Tak Kyu, Hwang, Insung, and Song, In‐Ae
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BENZODIAZEPINES , *RISK assessment , *NONSTEROIDAL anti-inflammatory agents , *STATISTICAL models , *SUBSTANCE abuse , *POST-traumatic stress disorder , *WOUNDS & injuries , *MUSCULOSKELETAL pain , *CHRONIC pain , *DIAZEPAM , *TRIAZOLAM , *T-test (Statistics) , *DISEASE duration , *STATISTICAL sampling , *CHLORDIAZEPOXIDE , *MULTIPLE regression analysis , *INSOMNIA , *MUSCULOSKELETAL system diseases , *QUESTIONNAIRES , *TRANQUILIZING drugs , *CAUSES of death , *DESCRIPTIVE statistics , *ALPRAZOLAM , *CHI-squared test , *AGE distribution , *SEVERITY of illness index , *RESPIRATORY diseases , *LONGITUDINAL method , *ODDS ratio , *NEUROLOGICAL disorders , *CHRONIC diseases , *ANALGESICS , *OPIOID analgesics , *GABAPENTIN , *DATA analysis software , *CLONAZEPAM , *SURVIVAL analysis (Biometry) , *CONFIDENCE intervals , *ANXIETY disorders , *COMORBIDITY , *PREGABALIN , *ACETAMINOPHEN , *PROPORTIONAL hazards models , *CLOBAZAM , *LORAZEPAM , *POISONING ,CARDIOVASCULAR disease related mortality - Abstract
Objectives: The impact of benzodiazepine use on mortality in patients with chronic non‐cancer pain (CNCP) has not been identified. We aimed to examine the factors associated with benzodiazepine use among patients with CNCP and examine whether long‐term benzodiazepine usage is associated with mortality in patients with CNCP. Methods: This study was conducted using data from the National Health Insurance Service database of South Korea. We selected 2.5% of all adult patients diagnosed with musculoskeletal diseases (MSD) in South Korea from 2010 to 2019 using a stratified random sampling technique and included them in the analysis as patients with CNCP. The risk of 10‐year all‐cause mortality in patients with CNCP was investigated using the 2010 cohort of patients with CNCP. Results: The proportion of the study population that used benzodiazepine during the 10‐year study period was 2.1% (390,683/18,770,234). Multivariable logistic regression showed that old age; increased Charlson comorbidity index (CCI); opioid, gabapentin or pregabalin, paracetamol, non‐steroidal anti‐inflammatory drugs, and Z‐drugs usage; and underlying psychiatric comorbidities were associated with increased benzodiazepine use. In addition, benzodiazepine use was associated with increased 10‐year all‐cause mortality (adjusted hazard ratio: 1.03, 95% confidence interval: 1.01, 1.06; p < 0.001). Conclusions: Benzodiazepine was prescribed to 2.1% of the patients with CNCP in South Korea from 2010 to 2019. Old age, increased CCI, underlying psychiatric comorbidities, and use of certain drugs are associated with increased use of benzodiazepines. In addition, benzodiazepine use is associated with 10‐year all‐cause mortality in patients with CNCP. [ABSTRACT FROM AUTHOR]
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- 2024
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16. The Benefit and Safety of Older Generation Anti-Epileptic Drugs (AEDs) in Drug-Resistant Epilepsy Children
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Roro Rukmi Windi Perdani, Principal investigator
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- 2023
17. Cerebral folate deficiency: a treatable cause of late deterioration in epilepsy with developmental delay.
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Chowdhury, Fahmida Amin, Sokolov, Elisaveta, Anderson, Jessica, Josifova, Dragana J., and Nashef, Lina
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FOLIC acid , *ELECTROENCEPHALOGRAPHY , *BRAIN , *MAGNETIC resonance imaging , *DEVELOPMENTAL disabilities , *AGE factors in disease , *INTELLECTUAL disabilities , *PHENYTOIN , *EPILEPSY , *SEIZURES (Medicine) , *CARBAMAZEPINE , *GABAPENTIN , *FOLIC acid deficiency , *CLOBAZAM , *PREGABALIN - Abstract
A 25-year-old woman with childhood-onset refractory epilepsy and developmental delay experienced a gradually progressive marked deterioration in mobility and seizure control, with language regression. Investigation identified a homozygous deletion within the contactin-associated protein-like 2 gene (CNTNAP2), underlying her early presentation, but also cerebral folate deficiency that most likely contributed to her later deterioration. Following antiseizure medication adjustment and treatment with folinic acid, she stabilised with improved seizure control and limited improvement in language and motor function; she has remained neurologically stable for more than a decade. That the previously observed neurological decline was halted by folinic acid replacement supports this being due to cerebral folate deficiency. Metabolic conditions are less well recognised in adults and can be under-diagnosed. They are potentially treatable and should be considered even in the presence of another cause, particularly when the presentation is not fully compatible. [ABSTRACT FROM AUTHOR]
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- 2024
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18. Corticosteroids versus clobazam for treatment of children with epileptic encephalopathy with spike-wave activation in sleep (RESCUE ESES): a multicentre randomised controlled trial.
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van Arnhem, Marleen M L, van den Munckhof, Bart, Arzimanoglou, Alexis, Perucca, Emilio, Metsähonkala, Liisa, Rubboli, Guido, Søndergaard Khinchi, Marianne, de Saint-Martin, Anne, Klotz, Kerstin A, Jacobs, Julia, Cross, J Helen, Garcia Morales, Irene, Otte, Wim M, van Teeseling, Heleen C, Leijten, Frans S S, Braun, Kees P J, and Jansen, Floor E
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CLOBAZAM , *EPILEPSY , *RANDOMIZED controlled trials , *CHILDREN with epilepsy , *CORTICOSTEROIDS , *RESPIRATORY infections - Abstract
Epileptic encephalopathy with spike-wave activation in sleep (EE-SWAS) is a rare syndrome associated with cognitive and behavioural regression. On the basis of mostly small observational and retrospective studies, corticosteroids and clobazam are often considered the most effective treatments for this syndrome. We aimed to compare cognitive outcomes of children with EE-SWAS 6 months after starting treatment with either corticosteroids or clobazam. We did a multicentre, randomised controlled trial at eight tertiary referral centres for rare epilepsies in seven European countries. Children were eligible to participate if they were aged 2–12 years, were diagnosed with EE-SWAS within 6 months before inclusion, and had not been treated with corticosteroids or clobazam previously. Participants were randomly assigned (1:1) to treatment with corticosteroids (either continuous treatment with 1–2 mg/kg per day of prednisolone orally or pulse treatment with 20 mg/kg per day of methylprednisolone intravenously for 3 days every 4 weeks) or clobazam (0·5–1·2 mg/kg per day orally). The primary outcome was cognitive functioning after 6 months of treatment, which was assessed by either the intelligence quotient (IQ) responder rate (defined as improvement of ≥11·25 IQ points) or the cognitive sum score responder rate (defined as improvement of ≥0·75 points). Safety was assessed by number of adverse events and serious adverse events. Data were analysed in the intention-to-treat population, which included all children as randomised who had primary outcome data available at 6 months. The trial is registered with the Dutch Trial Register, Toetsingonline, NL43510.041.13, and the ISRCTN registry, ISRCTN42686094. The trial was terminated prematurely because enrolment of the predefined number of 130 participants was deemed not feasible. Between July 22, 2014, and Sept 3, 2022, 45 children were randomly assigned to either corticosteroids (n=22) or clobazam (n=23); two children assigned clobazam dropped out before 6 months and were excluded from the intention-to-treat analysis. At the 6-month assessment, an improvement of 11·25 IQ points or greater was reported for five (25%) of 20 children assigned corticosteroids versus zero (0%) of 18 assigned clobazam (risk ratio [RR] 10·0, 95% CI 1·2–1310·4; p=0·025). An improvement of 0·75 points or more in the cognitive sum score was recorded for one (5%) of 22 children assigned corticosteroids versus one (5%) of 21 children assigned clobazam (RR 1·0, 95% CI 0·1–11·7, p=0·97). Adverse events occurred in ten (45%) of 22 children who received corticosteroids, most frequently weight gain, and in 11 (52%) of 21 children who received clobazam, most often fatigue and behavioural disturbances. Occurrence of adverse events did not differ between groups (RR 0·8, 95% CI 0·4–1·4; p=0·65). Serious adverse events occurred in one child in the corticosteroid group (hospitalisation due to laryngitis) and in two children in the clobazam group (hospitalisation due to seizure aggravation, and respiratory tract infection). No deaths were reported. The trial was terminated prematurely, and the target sample size was not met, so our findings must be interpreted with caution. Our data indicated an improvement in IQ outcomes with corticosteroids compared with clobazam treatment, but no difference was seen in cognitive sum score. Our findings strengthen those from previous uncontrolled studies that support the early use of corticosteroids for children with EE-SWAS. EpilepsieNL, WKZ fund, European Clinical Research Infrastructure Network, and Ming fund. [ABSTRACT FROM AUTHOR]
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- 2024
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19. Inconsolability in a Nonverbal Adolescent.
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Bhowal, Anushka, Cooper, Felicia, and Donner, Elizabeth
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PHYSICAL diagnosis , *X-rays , *NONVERBAL communication , *TACHYPNEA , *CHEST X rays , *LORAZEPAM , *CRYING , *TORSO , *AGITATION (Psychology) , *DEVELOPMENTAL disabilities , *DIFFERENTIAL diagnosis , *HAND , *TACHYCARDIA , *ANGER , *BLOOD cell count , *CLOBAZAM , *RETT syndrome , *BREATH holding , *ABDOMINAL radiography , *KETOROLAC , *SYMPTOMS , *ADOLESCENCE - Abstract
The article describes the case of a 13-year-old female with chronic medical history of presumed Rett syndrome (RTT) based on developmental regression and behavioral observation, microcephaly, seizure disorder, and gastrostomy tube dependence. Topics discussed include findings on medical examination of the patient, clinical characteristics of Rett syndrome, and differential diagnosis, workup, and outcomes of therapeutic interventions trialed for patient's agitation.
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- 2024
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20. Final analysis of potential drug–drug interactions between highly purified cannabidiol and anti‐seizure medications in an open‐label expanded access program.
- Author
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Gaston, Tyler E., Bebin, E. Martina, Cutter, Gary R., Grayson, Leslie, and Szaflarski, Jerzy P.
- Subjects
ANTICONVULSANTS ,DRUG interactions ,CANNABIDIOL ,SEX (Biology) ,CLOBAZAM - Abstract
Objective: The aim of this study was to assess potential drug–drug interactions between highly purified cannabidiol (CBD) and anti‐seizure medications (ASMs). Methods: Our group previously reported that in a sample of adults and children receiving CBD in an open‐label expanded access program, there were several ASMs noted to increase in serum levels with increasing doses of CBD. We analyzed if an increased number of observations over time resulted in changes in potential interactions and if potential interactions were associated with time since enrollment, demographics, or the overall rating of adverse effects. Results: In 169 participants (80 adults), with increasing weight‐based CBD dose, there were associated increases in serum levels of clobazam and N‐desmethylclobazam, free valproate, felbamate, and topiramate in the adult and pediatric arms combined, levetiracetam in the pediatric arm only, and permapanel in the adult arm only. There were no associations noted in these level changes with time since enrollment, biological sex, and adverse events profile scores. Significance: This study confirms some previously identified interactions with CBD and identifies other potential pharmacokinetic interactions; however, the clinical significance of these observations is likely minor, and there is no effect of time on these findings. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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- View/download PDF
21. An Open-label Extension Study to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol
- Published
- 2022
22. A Randomized Controlled Trial to Investigate Possible Drug-drug Interactions Between Clobazam and Cannabidiol
- Published
- 2022
23. Mutation in the GRIA4 Gene Presenting as ESES: Expanding the Genetic Landscape of ESES.
- Author
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Sharawat, Indar K., Gupta, Diksha, Mandal, Sharusa, Elwadhi, Aman, and Panda, Prateek K.
- Subjects
- *
STATUS epilepticus diagnosis , *SLEEP disorder diagnosis , *PHYSICAL diagnosis , *NEUROLOGIC examination , *ELECTROENCEPHALOGRAPHY , *STATUS epilepticus , *MAGNETIC resonance imaging , *PREDNISOLONE , *GENES , *GENETIC mutation , *SLOW wave sleep , *METHYLPREDNISOLONE , *SLEEP disorders , *CLOBAZAM - Published
- 2024
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24. NAVIGATING TUBEROUS SCLEROSIS IN A 41-YEAROLD PATIENT: CLINICAL INSIGHTS AND MANAGEMENT.
- Author
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Yanamadala, Pavan Kumar, Vemana, Hema Ratna Sai Lakshmi, Sana, Praveen, Allavarapu, Manogna, and Chikkala, Bhagya Aruna
- Subjects
TUBEROUS sclerosis diagnosis ,ERYTHROPOIETIN ,TUBEROUS sclerosis ,NITROGLYCERIN ,DIURETICS ,PRAZOSIN ,PHENYTOIN ,CLOBAZAM ,SYMPTOMS - Abstract
Introduction: 1. Tuberous sclerosis complex (TSC) is a rare genetic disorder distinguished by noncancerous growths in different parts of the body, particularly in the brain, skin, kidneys, heart, and lungs. It is caused by mutations in either the TSC1 or TSC2 genes, which interfere with the mTOR pathway. The range of symptoms associated with TSC can vary greatly, from minor skin manifestations to serious neurological complications such as epilepsy, cognitive deficits, and autism spectrum disorders. Case Nuances: The case study details a 41-year-old woman who received a belated diagnosis of TSC. She had a history of seizures over the past 26 years, with a physical examination revealing classic TSC features such as facial angiofibroma, enamel pits, and periungual flbromas. The patient also had a background of learning difficulties and common neurological symptoms of TSC. Discussion: Treatment for TSC typically targets specific symptoms, with antiepileptic medications prescribed for seizures and surgical interventions for sizable tumors. Regular monitoring is essential to detect potential complications early on. Conclusion: The case emphasizes the significance of prompt diagnosis and comprehensive care in TSC to enhance patient outcomes and well-being. Given the disease's diverse nature, regular check-ups and tailored treatment strategies are vital for effective management. [ABSTRACT FROM AUTHOR]
- Published
- 2024
25. Real‐world data on cannabidiol treatment of various epilepsy subtypes: A retrospective, multicenter study
- Author
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Fabienne Kühne, Lena‐Luise Becker, Thomas Bast, Astrid Bertsche, Ingo Borggraefe, Christian Malte Boßelmann, Jörg Fahrbach, Christoph Hertzberg, Nina A. Herz, Martin Hirsch, Martin Holtkamp, Christine Janello, Gerhard Josef Kluger, Gerhard Kurlemann, Holger Lerche, Konstantin L. Makridis, Felix vonPodewils, Milka Pringsheim, Susanne Schubert‐Bast, Juliane Schulz, Andreas Schulze‐Bonhage, David Steinbart, Bernhard J. Steinhoff, Adam Strzelczyk, Steffen Syrbe, Heike De Vries, Christiane Wagner, Johanna Wagner, Bernd Wilken, Christine Prager, Kerstin A. Klotz, and Angela M. Kaindl
- Subjects
cannabidiol ,clobazam ,drug‐resistant seizures ,DS ,epilepsy ,LGS ,Neurology. Diseases of the nervous system ,RC346-429 - Abstract
Abstract Objective Cannabidiol (CBD) is approved for treatment of Dravet syndrome (DS), Lennox‐Gastaut syndrome (LGS), and tuberous sclerosis complex (TSC). Several studies suggest antiseizure effects also beyond these three epilepsy syndromes. Methods In a retrospective multicenter study, we analyzed the efficacy and tolerability of CBD in patients with epilepsy at 16 epilepsy centers. Results The study cohort comprised 311 patients with epilepsy with a median age of 11.3 (0‐72) years (235 children and adolescents, 76 adults). Therapy with CBD was off‐label in 91.3% of cases due to age, epilepsy subtype, lack of adjunct therapy with clobazam, and/or higher dose applied. CBD titration regimens were slower than recommended, with good tolerability of higher doses particularly in children. Of all patients, 36.9% experienced a reduction in seizure frequency of >50%, independent of their epilepsy subtype or clobazam co‐medication. The median observation period was 15.8 months. About one third of all patients discontinued therapy within the observation period due to adverse effects or lack of efficacy. Adverse effects were reported frequently (46.9%). Significance Our study highlights that CBD has an antiseizure effect comparable to other antiseizure medications with a positive safety profile independent of the epilepsy subtype. Comedication with clobazam was not associated with a better outcome. Higher doses to achieve seizure frequency reduction were safe, particularly in children. These findings call for further trials for an extended approval of CBD for other epilepsy subtypes and for children
- Published
- 2023
- Full Text
- View/download PDF
26. A Case of Metabolic Encephalopathy Due to Recurrent Hypoglycemia Caused by Insulin: A Case Report.
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Dave, Kinjal A., Gupta, Sapna D., and Malhotra, Supriya D.
- Subjects
DIAGNOSIS of brain diseases ,INSULIN therapy ,METABOLIC disorder diagnosis ,TRACHEOTOMY ,CARDIOPULMONARY resuscitation ,BRAIN diseases ,COMBINATION drug therapy ,INTRAVENOUS therapy ,HETEROCYCLIC compounds ,INTUBATION ,TYPE 1 diabetes ,PANTOPRAZOLE ,MAGNETIC resonance imaging ,INSULIN ,DISEASE relapse ,METABOLIC disorders ,PENICILLIN ,METRONIDAZOLE ,TREATMENT effectiveness ,HYPOGLYCEMIA ,INTRAVENOUS injections ,CLOBAZAM ,SEIZURES (Medicine) ,CENTRAL venous catheters ,CEFOPERAZONE ,PHYSIOLOGIC salines ,DISEASE complications ,SYMPTOMS ,THERAPEUTICS - Abstract
A metabolic encephalopathy brought on by dangerously low blood glucose levels is called hypoglycemic encephalopathy. Transient hypoglycemic episodes are frequent, particularly in diabetic patients. This complication is seen in diabetes patients who are taking insulin/insulin secretagogues. Severe persistent hypoglycemia can result in seizures, a protracted state of coma, and a wide range of other global and focal neurologic impairments. The main pathological alterations in hypoglycemic encephalopathy include widespread denaturation and necrosis of the neurons as a result of a lack of energy, which is accompanied by a significant number of glial cells entering the brain. In our case, the patient had recurrent hypoglycemic episodes, which led to the development of hypoglycemic encephalopathy caused by insulin. It is important for clinicians to be aware of this potential complication and to closely monitor patients with diabetes who are being treated with insulin. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
27. Management of epilepsy with eyelid myoclonia: Results of an international expert consensus panel.
- Author
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Smith, Kelsey M., Wirrell, Elaine C., Andrade, Danielle M., Choi, Hyunmi, Trenité, Dorothée Kasteleijn‐Nolst, Jones, Hannah, Knupp, Kelly G., Mugar, Jon, Nordli, Douglas R., Riva, Antonella, Stern, John M., Striano, Pasquale, Thiele, Elizabeth A., and Zawar, Ifrah
- Subjects
- *
EYELIDS , *VALPROIC acid , *CHILDBEARING age , *EPILEPSY , *CLOBAZAM , *LAMOTRIGINE - Abstract
Objective: There are limited data about the treatment and management of epilepsy with eyelid myoclonia (EEM). The objective of this study was to determine areas of consensus among an international panel of experts for the management of EEM (formerly known as Jeavons syndrome). Methods: An international steering committee was convened of physicians and patients/caregivers with expertise in EEM. This committee summarized the current literature and identified an international panel of experts (comprising 25 physicians and five patients/caregivers). This panel participated in a modified Delphi process, including three rounds of surveys to determine areas of consensus for the treatment, other areas of management, and prognosis for EEM. Results: There was a strong consensus for valproic acid as the first‐line treatment, with levetiracetam or lamotrigine as preferable alternatives for women of childbearing age. There was a moderate consensus that ethosuximide and clobazam are also efficacious. There was a strong consensus to avoid sodium channel‐blocking medications, except for lamotrigine, as they may worsen seizure control. There was consensus that seizures typically persist into adulthood, with remission occurring in <50% of patients. There was less agreement about other areas of management, including dietary therapy, lens therapy, candidacy for driving, and outcome. Significance: This international expert panel identified multiple areas of consensus regarding the optimal management of EEM. These areas of consensus may inform clinical practice to improve the management of EEM. In addition, multiple areas with less agreement were identified, which highlight topics for further research. [ABSTRACT FROM AUTHOR]
- Published
- 2023
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28. OPTIMIZANDO EL APORTE DE HIDRATOS DE CARBONO DE LOS MEDICAMENTOS EN PACIENTES EPILÉPTICOS CON DIETA CETOGÉNICA.
- Author
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Villanueva, Javier Corazón, de la Torre Ortiz, María, García, Virginia Puebla, and Martínez Sesmero, José Manuel
- Subjects
- *
SORBITOL , *CLOBAZAM , *ONDANSETRON , *DIAZEPAM , *MIDAZOLAM , *VIMPAT - Published
- 2023
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29. Cessation of Drug-resistant Seizures with Clobazam in a Patient with Lipoid Proteinosis
- Author
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Ezgi Demirel Özbek, Özay Gököz, and Neşe Dericioğlu
- Subjects
lipoid proteinosis ,epilepsy ,drug-resistant seizures ,medial temporal lobe calcification ,clobazam ,Medicine ,Neurology. Diseases of the nervous system ,RC346-429 - Published
- 2023
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30. HOSPITAL GUILLERMO GRANT BENAVENTE DE CO invites tenders for Conv. Supply Clobazam 10 Mg Slotted Tablet
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Clobazam ,News, opinion and commentary - Abstract
HOSPITAL GUILLERMO GRANT BENAVENTE DE CO, Chile has invited tenders for Conv. Supply Clobazam 10 Mg Slotted Tablet. Tender Notice No: 4309-200-LE24 Deadline: July 1, 2024 Copyright © 2011-2022 pivotalsources.com. [...]
- Published
- 2024
31. PMSP - MUNICIPAL CITY HALL OF SAO PAULO invites tenders for Price Registration for the Supply of Medicines Clobazam, 10 Mg and 20 Mg - Legal Action
- Subjects
Clobazam ,News, opinion and commentary - Abstract
PMSP - MUNICIPAL CITY HALL OF SAO PAULO, Brazil has invited tenders for Price Registration for the Supply of Medicines Clobazam, 10 Mg and 20 Mg - Legal Action. Tender [...]
- Published
- 2024
32. Development of a robust UPLC-MS/MS method for the quantification of riluzole in human plasma and its application in pharmacokinetics.
- Author
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Zhuo Sun, Xin Liu, Wei Zuo, Qiang Fu, Tingting Xu, Liying Cui, Bo Zhang, and Ying Peng
- Subjects
AMYOTROPHIC lateral sclerosis ,RILUZOLE ,PHARMACOKINETICS ,LIQUID chromatography-mass spectrometry ,FORMIC acid ,MASS spectrometers - Abstract
Introduction: The aim of the present study was to establish a simple method for the determination of riluzole in human plasma by ultraperformance liquid chromatography-tandem mass spectrometry (UPLC-MS/MS) and apply it for the determination of riluzole in amyotrophic lateral sclerosis (ALS) patients. Methods: Samples were prepared by protein precipitation and were then gradient-eluted on a column of ACQUITY UPLC® HSS T3 by using 0.1% formic acid acetonitrile and 0.1% formic acid water as the mobile phase. Detection was performed on a Xevo TQ-S tandem mass spectrometer in the multiple-reaction monitoring mode using positive electrospray ionization. Validation was performed in the range of 5-800 ng/mL. Results and discussion: Three batches of precision accuracy, selectivity, matrix effects, extraction recovery, and stability were also verified and met the requirements. The results showed that the method was reliable and successfully applied to the pharmacokinetics study of riluzole in Chinese amyotrophic lateral sclerosis patients. Meanwhile, in comparison with other prior published methods, our method has the advantages of simple sample preparation, relatively short running time, and small plasma sample consumption, which represented a high-throughput sample determination potential. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
33. Tolerability of clobazam as add-on therapy in patients aged 50 years and older with drug-resistant epilepsy.
- Author
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Nagarajan, Elanagan, Lynch, Timothy M., Frawley, Bridget, and Bunch, Marjorie E.
- Subjects
- *
CLOBAZAM , *EPILEPSY , *OLDER people , *PEOPLE with epilepsy - Abstract
Objective: To evaluate the tolerability of clobazam in patients with drug-resistant epilepsy aged 50 years and older. Methods: We performed a single center, retrospective chart review of patients at least 50 years of age with drug resistant epilepsy of any type who started clobazam as an add on therapy. Retention rate, safety, and tolerability at 6 and 12 months and last follow-up, and the discontinuation rate due to side effects were analyzed. Results: A total of 26 patients met inclusion criteria. Mean age was 62 ± 7.1 years, and 69.2% of patients were female. The mean baseline seizure frequency before initiation of clobazam was 2 (range 1–30) seizures per month. The mean total daily dose of clobazam administered was 13 (range 5 to 30) mg/day. At the 12-month follow-up visit after clobazam initiation, 40% of patients were seizure-free and an additional 45% of patients had > 50% reduction in seizure frequency. The mean seizure frequency at 12-month follow-up was 1.5 (range 0–24) seizures per month. The mean total dose of clobazam at 12-month follow-up was 14.25 (range 5 to 25) mg/day. The mean duration of clobazam at last follow was 55.2 ± 27.02 (mean ± SD months) and 18 (69.2%) patients remained on clobazam. Twenty out of 26 (76.9%) patients reported at least one side effect and 6/26 (23%) discontinued the medication within a month of initiation. At last follow-up, 40% remained seizure free on stable dosing. Conclusion: Clobazam can be a safe and tolerable, add-on treatment older adults with drug-resistant epilepsy. Those who responded tolerated the medication well. Discontinuation due to side effects occurred soon after initiation of therapy. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
34. Development and validation of a liquid chromatography–tandem mass spectrometry method of a panel of commonly prescribed benzodiazepines in urine samples.
- Author
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Karakukcu, Cigdem and Saracoglu, Hatice
- Subjects
- *
LIQUID chromatography-mass spectrometry , *BENZODIAZEPINES , *CLOBAZAM , *URINE - Abstract
Benzodiazepines are one of the most prescribed for therapeutic purposes and the most abused drugs. Therefore, liquid chromatography–tandem mass spectrometry–based methods that analyze several benzodiazepines simultaneously are required. In this study, we developed a simple, full validated in‐house method in a single‐triple quadrupole platform SCIEX QTRAP 4500 system for the simultaneous detection and quantification of the 10 most prescribed benzodiazepines within a 10‐min run time. The linear range was 12.5–500 ng/mL. All limits of detection were below 4.03 ng/mL and limits of quantitation below 12.22 ng/mL, except clobazam (7.27 and 22.04 ng/mL, respectively). Both the limit of detection and quantitation were lowest for diazepam (0.95 and 2.89 ng/mL, respectively). The method was evaluated for accuracy, precision, carry‐over, recovery, stability, and matrix effects, and all validation studies met internationally acceptable criteria. The applicability of the method was proven by analyzing authentic urine samples, internal, and third‐party external quality samples. This precise, accurate, shorter total run time and ease of urine sample analysis method is applicable in detecting most prescribed benzodiazepines and their metabolites even in glucuronide forms. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
35. Retrospective chart review study of use of cannabidiol (CBD) independent of concomitant clobazam use in patients with Lennox-Gastaut syndrome or Dravet syndrome.
- Author
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Nabbout, Rima, Arzimanoglou, Alexis, Auvin, Stéphane, Berquin, Patrick, Desurkar, Archana, Fuller, Douglas, Nortvedt, Charlotte, Pulitano, Patrizia, Rosati, Anna, Soto, Victor, Villanueva, Vicente, and Cross, J. Helen
- Abstract
• Retrospective chart review: add-on CBD without clobazam in LGS (n = 92); DS (n = 15). • Retention on CBD without clobazam was 63% at 12 months. • AEs (e.g., diarrhoea and somnolence) were reported in 31% of patients. • Results support effectiveness of CBD without clobazam in clinical practice. This retrospective chart review study (GWEP20052) evaluated plant-derived highly purified cannabidiol (CBD; Epidyolex®; 100 mg/mL oral solution) use without clobazam as add-on therapy in patients aged ≥2 years with Lennox-Gastaut syndrome (LGS) or Dravet syndrome (DS) enrolled in a European Early Access Program. Data were extracted from patient charts covering a period starting 3 months before CBD treatment and concluding after 12 months of CBD treatment, or sooner if a patient discontinued CBD or started clobazam. Of 114 enrolled patients, data were available for 107 (92 LGS, 15 DS) who received CBD without clobazam for ≥3 months. Mean age: 14.5 (LGS) and 10.5 (DS) years; female: 44% (LGS) and 67% (DS). Mean time-averaged CBD dose: 13.54 (LGS) and 11.56 (DS) mg/kg/day. Median change from baseline in seizure frequency per 28 days over 3-month intervals varied from −6.2% to −20.9% for LGS and 0% to −16.7% for DS. Achievement of ≥50% reduction in drop (LGS) or convulsive (DS) seizures at 3 and 12 months: LGS, 19% (n = 69) and 30% (n = 53); DS, 21% (n = 14) and 13% (n = 8). Retention on CBD without clobazam (enrolled set): 94%, 80%, 69%, and 63% at 3, 6, 9, and 12 months. Adverse event (AE) incidence was 31%, most commonly somnolence, seizure, diarrhea, and decreased appetite. Two patients discontinued CBD owing to AEs, and four patients with LGS experienced elevated liver enzymes. Results support favorable effectiveness and retention of CBD without concomitant clobazam for up to 12 months in clinical practice. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
36. Treatment of drop attacks: Anti-seizure drug choices of pediatric neurologists in Saudi Arabia.
- Author
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Alhiniah, Mudhawi, Alshahrani, Asma, Rajab, Renad, Alelyani, Rakan, Badawi, Atheer, Abbar, Abrar, Abdulsbhan, Mashael, Alrajhi, Amir, Muthaffar, Osama, and Jan, Mohammed
- Subjects
SYNCOPE ,NEUROLOGISTS ,EPILEPSY ,VALPROIC acid ,CLOBAZAM - Abstract
Copyright of Neurosciences is the property of Neurosciences and its content may not be copied or emailed to multiple sites or posted to a listserv without the copyright holder's express written permission. However, users may print, download, or email articles for individual use. This abstract may be abridged. No warranty is given about the accuracy of the copy. Users should refer to the original published version of the material for the full abstract. (Copyright applies to all Abstracts.)
- Published
- 2023
- Full Text
- View/download PDF
37. Real‐world data on cannabidiol treatment of various epilepsy subtypes: A retrospective, multicenter study.
- Author
-
Kühne, Fabienne, Becker, Lena‐Luise, Bast, Thomas, Bertsche, Astrid, Borggraefe, Ingo, Boßelmann, Christian Malte, Fahrbach, Jörg, Hertzberg, Christoph, Herz, Nina A., Hirsch, Martin, Holtkamp, Martin, Janello, Christine, Kluger, Gerhard Josef, Kurlemann, Gerhard, Lerche, Holger, Makridis, Konstantin L., von Podewils, Felix, Pringsheim, Milka, Schubert‐Bast, Susanne, and Schulz, Juliane
- Abstract
Objective: Cannabidiol (CBD) is approved for treatment of Dravet syndrome (DS), Lennox‐Gastaut syndrome (LGS), and tuberous sclerosis complex (TSC). Several studies suggest antiseizure effects also beyond these three epilepsy syndromes. Methods: In a retrospective multicenter study, we analyzed the efficacy and tolerability of CBD in patients with epilepsy at 16 epilepsy centers. Results: The study cohort comprised 311 patients with epilepsy with a median age of 11.3 (0‐72) years (235 children and adolescents, 76 adults). Therapy with CBD was off‐label in 91.3% of cases due to age, epilepsy subtype, lack of adjunct therapy with clobazam, and/or higher dose applied. CBD titration regimens were slower than recommended, with good tolerability of higher doses particularly in children. Of all patients, 36.9% experienced a reduction in seizure frequency of >50%, independent of their epilepsy subtype or clobazam co‐medication. The median observation period was 15.8 months. About one third of all patients discontinued therapy within the observation period due to adverse effects or lack of efficacy. Adverse effects were reported frequently (46.9%). Significance: Our study highlights that CBD has an antiseizure effect comparable to other antiseizure medications with a positive safety profile independent of the epilepsy subtype. Comedication with clobazam was not associated with a better outcome. Higher doses to achieve seizure frequency reduction were safe, particularly in children. These findings call for further trials for an extended approval of CBD for other epilepsy subtypes and for children <2 years of age. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
38. Expert Consensus on Clobazam in the Treatment of Refractory Epilepsy (2022)
- Author
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Multi-disciplinary Team for Rare Diseases, Peking Union Medical College Hospital National Rare Diseases Committee
- Subjects
clobazam ,refractory epilepsy ,expert consensus ,rare diseases ,orphan drug ,Medicine - Abstract
After regular anti-epileptic drug treatment, the symptoms of most patients with epilepsy can be well controlled or relieved, but 30%-40% of patients with epilepsy, after long-term drug treatment, still suffer from repeated seizures and develop refractory epilepsy. Lennox-Gastaut syndrome, Dravet syndrome and epilepsy with myoclonic-atonic seizures are all refractory epilepsy that originate in childhood and seriously threaten the physical and mental health of patients. In 2011, clobazam was approved by the US Food and Drug Administration for the adjunctive treatment of epileptic seizures in patients with Lennox-Gastaut syndrome aged≥2 years. The drug has also been used in the treatment of Dravet syndrome and epilepsy with myoclonic-atonic seizures. Currently, the mechanism of action of clobazam is still unclear, but it may exert pharmacological effects by binding to the benzodiazepine site on the γ-aminobutyric acid A receptor. In vivo, clobazam and N-desmethylclobazam are mainly metabolized by CYP3A4 and CYP2C19, and the interaction with other drugs should require vigilance in clinical application. Meanwhile, attention should also be paid to the blood concentration of N-desmethylclobazam and monitoring of drug-related adverse reactions in CYP2C19 poor metabolizers. To promote further standardization of clinical application of clobazam in our country, and to ensure the effectiveness and safety of clobazam, the Multi-disciplinary Team for Rare Diseases, Peking Union Medical College Hospital and the National Rare Diseases Committee organized experts and scholars in related fields, and after many discussions and revisions, finally formed this consensus for clinical reference.
- Published
- 2022
- Full Text
- View/download PDF
39. Use of Clobazam for Epilepsy and Anxiety
- Author
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Jay Salpekar, M.D., Principal Investigator
- Published
- 2021
40. A retrospective non‐interventional study evaluating the pharmacokinetic interactions between cenobamate and clobazam.
- Author
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Elakkary, Sally, Hagemann, Anne, Klimpel, Dennis, Bien, Christian G., and Brandt, Christian
- Subjects
- *
CLOBAZAM , *DRUG interactions , *EPILEPSY , *DRUG monitoring - Abstract
Cenobamate is an antiseizure medication (ASM) approved for the treatment of partial‐onset seizures in adults. As both an inductor and an inhibitor of hepatic enzymes, cenobamate affects the metabolism of other ASMs, among which is clobazam. To our knowledge, the extent of interaction between cenobamate and clobazam and its clinical significance have not been studied yet. In this retrospective study we assessed serum concentrations of clobazam and N‐desmethylclobazam (NCLB)in five patients before and after co‐medication with cenobamate and calculated the percentage increase in concentration‐to‐dose ratio (CDR) of both. We were able to demonstrate that the addition of cenobamate resulted in an increase in serum concentration and consequently in CDR of NCLB in all patients. However this occurred in variable degrees: NCLB concentration showed an increase of 1208 μg/L (CDR145%) in one patient and between 1691 μ/L (CDR 819%) and 3995 μ/L (CDR 1852%) in the other four. This resulted in fatigue, which improved after dose reduction of CLB. Therefore, it is to be concluded that concomitant administration of cenobamate and clobazam can lead to a substantial increase in serum concentrations of NCLB. This can have a positive therapeutic effect on one hand; however, on the other hand, this can lead to unwanted fatigue. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
41. Psychiatric Approach in Phantom Erection Postpenectomy Patient.
- Author
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Arizona, Popy, Yulianti, Erikavitri, and Fithriyah, Izzatul
- Subjects
- *
REIMPLANTATION (Surgery) , *COUPLES therapy , *COUPLES counseling , *PHANTOM limbs , *RELAXATION therapy , *CLOBAZAM , *WORRY - Abstract
Introduction. Phantom limb pain is a pain sensation experienced in the area of the missing body part. The pain generally appears in the first few days after surgery. PLP could occur in teeth, tongue, breast, eyes, rectum, bladder, testicles, and penis. Phantom pain in the penis is not only felt as pain but sometimes as an erection or urination, even after the removal of the penis. Clinical Case. A 35-year-old man was referred to the psychiatrist due to phantom erection after undergoing reimplantation of the penis by the urologist. A few days before the referral, he was admitted to the emergency department after a penile amputation that his wife performed. During the recovery phase after the penile reimplantation procedure, the patient worried about his penis' outcome and became depressed. The patient was in severe anxiety and moderate-to-severe depression status. Treatment. The patient was given nonpsychopharmacology such as supportive psychotherapy, family psychoeducation, relaxation and marital therapy, and psychopharmacology, such as amitriptyline 12.5 Mg PO two times a day and clobazam 10 Mg PO each day for 3 months. One and a half months later, his anxiety and depression were better. Conclusion. A psychiatric approach was needed in an amputated limb patient with psychopathologic symptoms. Nonpsychopharmacotherapy and psychopharmacotherapy were needed if the patient had symptoms. Further studies with a large number will be necessary to validate the psychiatric approach in amputated limb patients with psychopathologic symptoms cases. [ABSTRACT FROM AUTHOR]
- Published
- 2023
- Full Text
- View/download PDF
42. Long‐term efficacy and safety of cannabidiol in patients with treatment‐resistant epilepsies: Four‐year results from the expanded access program.
- Author
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Szaflarski, Jerzy P., Devinsky, Orrin, Lopez, Merrick, Park, Yong D., Zentil, Pilar Pichon, Patel, Anup D., Thiele, Elizabeth A., Wechsler, Robert T., Checketts, Daniel, and Sahebkar, Farhad
- Subjects
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PEOPLE with epilepsy , *PATIENT safety , *SEIZURES (Medicine) , *CANNABIDIOL , *CLOBAZAM - Abstract
Objective: Cannabidiol (CBD) expanded access program, initiated in 2014, provided add‐on CBD to patients with treatment‐resistant epilepsies (TREs) at 35 US epilepsy centers. Prior publications reported results through December 2016; herein, we present efficacy and safety results through January 2019. Methods: Patients received plant‐derived highly purified CBD (Epidiolex®; 100 mg/ml oral solution), increasing from 2 to 10 mg/kg/day to tolerance or maximum 25–50 mg/kg/day dose, depending on the study site. Efficacy endpoints included percentage change from baseline in median monthly convulsive and total seizure frequency and ≥50%, ≥75%, and 100% responder rates across 12‐week visit windows for up to 192 weeks. Adverse events (AEs) were documented at each visit. Results: Of 892 patients in the safety analysis set, 322 (36%) withdrew; lack of efficacy (19%) and AEs (7%) were the most commonly reported primary reasons for withdrawal. Median (range) age was 11.8 years (range = 0–74.5), and patients were taking a median of three (range = 0–10) antiseizure medications (ASMs) at baseline; the most common ASMs were clobazam (47%), levetiracetam (34%), and valproate (28%). Median top CBD dose was 25 mg/kg/day; median exposure duration was 694 days. Median percentage reduction from baseline ranged 50%–67% for convulsive seizures and 46%–66% for total seizures. Convulsive seizure responder rates (≥50%, ≥75%, and 100% reduction) ranged 51%–59%, 33%–42%, and 11%–17% of patients across visit windows, respectively. AEs were reported in 88% of patients and serious AEs in 41%; 8% withdrew because of an AE. There were 20 deaths during the study deemed unrelated to treatment by the investigator. The most common AEs (≥20% of patients) were diarrhea (33%), seizure (24%), and somnolence (23%). Significance: Add‐on CBD was associated with sustained seizure reduction up to 192 weeks with an acceptable safety profile and can be used for long‐term treatment of TREs. [ABSTRACT FROM AUTHOR]
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- 2023
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43. EU Contract Notice: GWQ ServicePlus AG Issues contract notice|solicitation for 'Conclusion of non-exclusive discount agreements pursuant to Section 130 a Paragraph 8 SGB V with the active ingredient Clobazam'
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Clobazam ,Contract agreement ,Business, international - Abstract
Luxembourg: GWQ ServicePlus AG has issued contract notice/solicitation for 'Conclusion of non-exclusive discount agreements pursuant to Section 130 a Paragraph 8 SGB V with the active ingredient Clobazam' Reference no: [...]
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- 2024
44. GUARULHOS CITY HALL invites tenders for Registration of Prices for Arpiprazole, Clobazam, Divalproex Sodium and Others - other Specifications as Per Notice
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Clobazam ,Valproic acid ,Divalproex ,News, opinion and commentary - Abstract
GUARULHOS CITY HALL, Brazil has invited tenders for Registration of Prices for Arpiprazole, Clobazam, Divalproex Sodium and Others - other Specifications as Per Notice.. Tender Notice No: 90026/2024 Deadline: April [...]
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- 2024
45. PMSP - MUNICIPAL CITY HALL OF SAO PAULO invites tenders for Price Registration for the Supply of Clobazam, 10 Mg, Cx C/ 20 Cp (Frisium) and Others - Legal Action by the Municipal Health Department of Sao Paulo/Sp
- Subjects
Clobazam ,News, opinion and commentary - Abstract
PMSP - MUNICIPAL CITY HALL OF SAO PAULO, Brazil has invited tenders for Price Registration for the Supply of Clobazam, 10 Mg, Cx C/ 20 Cp (Frisium) and Others - [...]
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- 2024
46. SUPPLY CENTER OF THE NATIONAL HEALTH SERVICE SYSTEM invites tenders for Clobazam 10 Mg Cmcm Rec 1000019540
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Clobazam ,Socialized medicine ,News, opinion and commentary - Abstract
SUPPLY CENTER OF THE NATIONAL HEALTH SERVICE SYSTEM, Chile has invited tenders for Clobazam 10 Mg Cmcm Rec 1000019540. Tender Notice No: 621-266-LR24 Deadline: April 4, 2024 Copyright © 2011-2022 [...]
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- 2024
47. Dose Adjustment of Concomitant Antiseizure Medications During Cenobamate Treatment: Expert Opinion Consensus Recommendations.
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Smith, Michael C., Klein, Pavel, Krauss, Gregory L., Rashid, Samiya, Seiden, Lawrence G., Stern, John M., and Rosenfeld, William E.
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SEIZURES (Medicine) , *DRUGS , *DRUG interactions , *PEOPLE with epilepsy , *CLOBAZAM - Abstract
Introduction: Our objective was to provide expert consensus recommendations to improve treatment tolerability through dose adjustments of concomitant antiseizure medications (ASMs) during addition of cenobamate to existing ASM therapy in adult patients with uncontrolled focal seizures. Methods: A panel of seven epileptologists experienced in the use of ASMs, including cenobamate, used a modified Delphi process to reach consensus. The panelists discussed tolerability issues with concomitant ASMs during cenobamate titration and practical strategies for dose adjustments that may prevent or mitigate adverse effects. The resulting recommendations consider concomitant ASM dose level and specify proactive (prior to report of an adverse effect) and reactive (in response to report of an adverse effect) dose adjustment suggestions based on concomitant ASM pharmacokinetic and pharmacodynamic interactions with cenobamate. Specific dose adjustment recommendations are provided. Results: We recommend proactively lowering the dose of clobazam, phenytoin, and phenobarbital due to their known drug–drug interactions with cenobamate, and lacosamide due to a pharmacodynamic interaction with cenobamate, to prevent adverse effects during cenobamate titration. Reactive lowering of a concomitant ASM dose is sufficient for other ASMs at standard dosing owing to quick resolution of adverse effects. For carbamazepine and lamotrigine doses exceeding the upper end of standard dosing (e.g., carbamazepine, greater than 1200 mg/day; lamotrigine, greater than 500 mg/day), we encourage consideration of proactive dose reduction at cenobamate 200 mg/day to prevent potential adverse effects. All dose reductions for adverse effects can be repeated every 2 weeks as dictated by the adverse effects. At cenobamate 200 mg/day, we recommend that patients be evaluated for marked improvement of seizures and further dose reductions be considered to reduce potentially unnecessary polypharmacy. Conclusion: The primary goal of the recommended dose reductions of concomitant ASMs is to prevent or resolve adverse effects, thereby allowing cenobamate to reach the optimal dose to achieve the maximal potential of improving seizure control. Plain Language Summary: Some people with epilepsy need to take more than one seizure medicine as part of their treatment. Taking more than one seizure medicine, however, can increase the risk of unwanted side effects. One approach to preventing side effects when adding a new seizure medicine is to lower the amount (dose) of existing seizure medicines. Cenobamate is a newer seizure medicine available in the USA for adults with focal seizures (also referred to as partial-onset seizures). Cenobamate, like many seizure medicines, must be titrated over time to a target dose. A group of epilepsy specialists met and developed recommendations for when and how to change the doses of existing seizure medicines when adding cenobamate. The goal of these recommendations is to prevent or reduce side effects like sleepiness or dizziness. The authors recommend that the dose of specific seizure medicines, including clobazam, lacosamide, phenytoin, and phenobarbital, be lowered as cenobamate is started or as cenobamate's dose is being increased (but before side effects occur). Regular doses of other seizure medicines can be lowered if a side effect occurs because reducing the dose of the other seizure medications can often stop the side effect. These recommendations may help patients successfully reach their optimal dose of cenobamate with fewer side effects, potentially improving their seizure control. [ABSTRACT FROM AUTHOR]
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- 2022
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48. Retrospective analysis of metabolite patterns of clobazam and N-desmethylclobazam in human plasma by LC-MS/MS
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Amol O. Bajaj, Diane Ly, and Kamisha L. Johnson-Davis
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Clobazam ,N-Desmethylclobazam ,Plasma ,LC-MS/MS ,Retrospective data analysis ,Medical technology ,R855-855.5 - Abstract
Introduction: Clobazam is a benzodiazepine drug, used to treat Lennox-Gastaut syndrome in patients aged 2 years and older. Objective: To support patient care, our laboratory developed a liquid chromatography tandem mass spectrometry (LC-MS/MS) method for the quantification of clobazam (CLB) and its major active metabolite N-desmethylclobazam (N-CLB) in human plasma or serum samples. Methods: The chromatographic separation was achieved with an Agilent Zorbax Eclipse Plus C-18 RRHD column with mobile phase consisting of 0.05% formic acid in 5 mM ammonium formate, pH 3.0 and 0.1% formic acid in acetonitrile at a flow rate of 600 µL/minute and an injection volume of 5 µL. The detection was performed on a triple quadrupole mass spectrometer in multiple reaction monitoring mode to monitor precursor-to-product ion transitions in positive electrospray ionization mode. Results: The method was validated over a concentration range of 20–2000 ng/mL for CLB and 200–10,000 ng/mL for N-CLB. The lower limit of quantification was 20 ng/mL for CLB and 200 ng/mL for N-CLB with good accuracy and precision. The method performance was successfully evaluated by comparison with two different external laboratories. Retrospective data analysis was performed to evaluate the positivity rate and metabolic patterns for clobazam from our patient population, as a reference laboratory. Among the positive samples, both parent and metabolite were detected in 96.4% of the samples. Conclusion: The method was developed to support therapeutic drug monitoring and the data generated from retrospective analysis could be useful for result interpretation in conjunction with clinical patient information.
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- 2022
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49. Efficacy and safety of phenytoin versus clobazam as monotherapy for newly diagnosed epileptic patients
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Saborni Dey, Anil Kumar Kem, Yatish, and Somya Agarwal
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epilepsy ,phenytoin ,clobazam ,monotherapy ,Medicine - Abstract
Background: Epilepsy is a chronic disorder characterized not only by recurrent seizures but also by a great variety of medical and psychosocial implications. Its burden to the patients and their families has been recognized and even the impact upon the community is vast. Aims and Objectives: The aim of the study was to compare the efficacy and safety of phenytoin and clobazam in monotherapy for the management of new onset, untreated epileptic patients. Materials and Methods: A 6 months, observational, comparative study was conducted on 60 adult patients with epilepsy. The eligible patients were given either phenytoin sodium (Group A; n=30) in a loading dose of 15 mg/kg orally, followed by 5 mg/kg/day maintenance dose for 6 months while Group-B (n=30) received clobazam in a dose of 1 mg/kg oral loading dose followed by 0.5 mg/kg/day. Seizure frequency was evaluated and compared with baseline at 1, 2, 3, 4.5, 6 months along with adverse drug reaction assessment. Results: In Group A mean pre-treatment baseline seizure frequency was 6.3±2.19 and for Group B 5.80±2.22. After 6 months, seizure frequency for Group A 2.30±1.99 and in Group B 1.30±1.91. In Group B, there was a significantly higher reduction in seizure frequency (P=0.001) than that of Group A. Both the drug groups significantly reduced the seizure frequency but Group B was found to be superior. Adverse drug reaction was more in Group A in comparison with Group B. The common side effects were drowsiness, weight gain, headache, tiredness, nausea and ataxia. Conclusion: Clobazam monotherapy had demonstrated better efficacy than phenytoin for the treatment of epilepsy and also well tolerated.
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- 2022
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50. Addition of clobazam successfully treating drug resistant seizures in Heidenhain variant Creutzfeldt Jakob disease: A case report
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Jason M. Maille, Sebastian S. Hanna, and Darshan N. Shah
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Creutzfeldt Jakob disease ,Seizure ,Benzodiazepine ,Clobazam ,RT-QuIC ,Heidenhain variant ,Neurology. Diseases of the nervous system ,RC346-429 ,Neurophysiology and neuropsychology ,QP351-495 - Abstract
Creutzfeldt Jakob Disease (CJD) is a rapidly progressive and fatal neurodegenerative disease that is uncommonly accompanied with seizures. In this case report, we describe a 63-year-old male patient who presented with a 3-week history of visual disturbances and clonic movement of his left arm. Additionally, the patient was reported to have developed erratic behaviors along with insomnia during this period. An EEG showed 4 electrographic seizures of bilateral temporo-occipital onset characterized by 1.5 Hz periodic discharges, lasting 2–13 min. Levetiracetam was started and titrated to the maximal dose however seizures continued so lacosamide and clonazepam were initiated. Despite these aggressive treatments, seizures continued, and oral clobazam 5 mg BID replaced clonazepam. Continued electrographic seizures warranted an increase in clobazam to 10 mg BID after which the seizures stopped; of note, lateralized periodic discharges (LPDs) remained. The patient’s symptoms were consistent with the Heidenhain variant, along with probable CJD due to positive RT-QuIC assay, positive 14-3-3 protein, MRI FLAIR hyperintensities, and EEG findings. Although the patient passed away 3 weeks following admission as a result of CJD, we propose that there may be clinical benefit in the use of clobazam in suspected CJD patients presenting with seizures, and its use merits further investigation.
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- 2023
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