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4. Efficacy and safety of eslicarbazepine acetate as a first or later adjunctive therapy in patients with focal seizures

Author

Hixson, John, Gidal, Barry, Pikalov, Andrei, Zhang, Yi, Mehta, Darshan, Blum, David, Cantu, David, Grinnell, Todd, and Investigators, on behalf of the Study 701

Subjects
Biomedical and Clinical Sciences, Clinical Sciences, Brain Disorders, Epilepsy, Depression, Clinical Research, Neurosciences, Behavioral and Social Science, Mental Health, Comparative Effectiveness Research, Neurodegenerative, Clinical Trials and Supportive Activities, 6.1 Pharmaceuticals, Evaluation of treatments and therapeutic interventions, Anticonvulsants, Dibenzazepines, Double-Blind Method, Humans, Lamotrigine, Levetiracetam, Quality of Life, Seizures, Treatment Outcome, Adjunctive therapy, Anti-seizure medication, Clinical trial, Eslicarbazepine acetate, Focal seizure, Real world, Study 701 Investigators, Neurology & Neurosurgery
Abstract

IntroductionWe report outcomes from an open-label, non-randomized, 24-week study of eslicarbazepine acetate (ESL) in adults at earlier and later stages of their treatment history for focal seizures, conducted in a real-world clinical setting.MethodsESL was taken as the first adjunctive therapy to levetiracetam (LEV) or lamotrigine (LTG) monotherapy (Arm 1), or as a later adjunctive therapy in treatment-resistant patients (Arm 2). The primary objective was to evaluate the effectiveness of ESL (by retention rates). Secondary objectives were to evaluate efficacy (seizure frequency), safety, tolerability, behavioral changes, mood, and health-related quality of life (HRQoL) associated with ESL treatment.ResultsThe modified intent-to-treat population included 96 patients (Arm 1: n = 41; Arm 2: n = 55) and the safety population included 102 patients (Arm 1: n = 44; Arm 2: n = 58). Overall, 81.8 % of patients in Arm 1 and 63.8 % of patients in Arm 2 completed the 24-week maintenance period. Median reductions in standardized seizure frequency (SSF) were markedly higher in Arm 1 (72.8 %) than Arm 2 (22.8 %), as were responder rates (≥50 % reduction in SSF; Arm 1: 62.5 %; Arm 2: 38.5 %) and rates of seizure freedom (Arm 1: 25.0 %; Arm 2: 9.6 %). Efficacy outcomes were generally more favorable in patients taking ESL in combination with LEV versus other anti-seizure medications (ASMs). Treatment-emergent adverse events (TEAEs; 81 % vs 73 %) and TEAEs leading to discontinuation (16 % vs 2 %) were reported more frequently in Arm 2 than Arm 1, respectively. Serious adverse events were reported infrequently (Arm 1: 0; Arm 2: 7 %). The most common TEAEs were dizziness, nausea, headache, somnolence, fatigue, nasopharyngitis, vomiting, and anxiety. There were no notable changes in depressive symptoms, mood status, or aggression throughout the study. Health and HRQoL scores were generally high at baseline and did not change throughout the study. However, on average, both clinicians and patients perceived improvement in illness over the course of the study.ConclusionsESL was effective and well tolerated both as the first adjunctive therapy to either of the most prescribed first-line ASMs, LEV or LTG, and as a later adjunctive therapy in treatment-resistant patients.

Published
2021

24. Implementing Digital Technologies in Clinical Trials: Lessons Learned

Author

Mitsi, Georgia, Grinnell, Todd, Giordano, Suzanne, Goodin, Thomas, Sanjar, Shahin, Marble, Elizabeth, and Pikalov, Andrei

Subjects
Review
Abstract

Multiple digital health technologies have been evaluated across clinical development programs, including external, wearable, implantable, and ingestible devices and sensors, along with digital mobile health applications (apps) that are accessible via users' personal electronic devices (e.g., smartphones, tablets, and computers). Several of these technologies have been incorporated into our ongoing neurology and respiratory clinical development programs. Based on our experience, one of the greatest potential benefits of digital health technologies is the ability to collect objective and/or biological data continuously or at regular intervals outside of office visits during a patient's normal daily activities to provide additional efficacy and safety information, versus data capture from traditional episodic, time point-based office visits. Many challenges encountered with digital health technologies can be successfully addressed by providing the appropriate training to staff and patients, ensuring availability of appropriate infrastructure support, and conducting pilot studies before scaling up to larger trials. Overall, our experience with digital health technologies demonstrated their potential to increase the amount of objective data collected in clinical trials, expand patient access to trials, and facilitate further improvement of clinical outcomes.

Published
2022

27. Comparative Economic Outcomes in Patients with Focal Seizure Initiating First-Line Eslicarbazepine Acetate Monotherapy versus Generic Antiseizure Drugs

Author

Mehta,Darshan, Davis,Matthew, Epstein,Andrew J, Wensel,Brian, Grinnell,Todd, Williams,G Rhys, Mehta,Darshan, Davis,Matthew, Epstein,Andrew J, Wensel,Brian, Grinnell,Todd, and Williams,G Rhys

Abstract

Darshan Mehta,1 Matthew Davis,2 Andrew J Epstein,3 Brian Wensel,1 Todd Grinnell,4 G Rhys Williams1 1Sunovion Pharmaceuticals Inc., Marlborough, MA, USA; 2Medicus Economics, LLC, Milton, MA, USA; 3Medicus Economics, LLC, Philadelphia, PA, USA; 4Medical Affairs, Sunovion Pharmaceuticals Inc., Marlborough, MA, USACorrespondence: Darshan MehtaAssociate Director, Health Economics and Outcomes Research, Sunovion Pharmaceuticals Inc, 84 Waterford Drive, Marlborough, MA, 01752, USATel +1-774-369-7913Email Darshan.Mehta@sunovion.comObjective: To examine the association between initiating first-line (1L) monotherapy with eslicarbazepine acetate (ESL) vs a generic antiseizure drug (ASD) and healthcare resource utilization (HCRU) and charges in adults with treated focal seizures (FS).Methods: This was a retrospective analysis of Symphony Health’s Integrated Dataverse® open-source claims data. Two cohorts were identified as having initiated 1L monotherapy with ESL or literature-defined generic ASDs. Linear regression models with person fixed effects and inverse probability treatment weights assessed the relative additional changes in HCRU and charges among patients who received ESL compared to generic ASD.Results: A total of 250 and 43,220 patients initiated ESL (48.3 years; 57.2% female) or a generic ASD (54.5 years; 58.1% female), respectively. Compared to patients initiating a generic ASD, patients treated with ESL had additional reductions of 11.8 percentage points in the likelihood of any all-cause outpatient visits (P< 0.001), 7.4 percentage points in the likelihood of any emergency department (ED) visits (P=0.013), and 22.7 percentage points in the likelihood of any FS-related outpatient visits (P< 0.001). Patients initiating ESL had greater reductions in mean charges for all-cause medical ($2620; P=0.002), outpatient ($1995; P=0.005), and non-FS-related medical ($2708; P< 0.001) services. Patients initiating ESL had greater relative

Published
2021

34. Long-term Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4–17 years) with Focal Seizures (263)

Author

Sankar, Raman, primary, Kirkham, Fenella, additional, Holmes, Gregory L., additional, Pina-Garza, Jesus, additional, Wheless, James, additional, Grinnell, Todd, additional, Cantu, David, additional, Gama, Helena, additional, Moreira, Joana, additional, Tosiello, Robert, additional, and Blum, David, additional

Published
2020
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41. Conversion to eslicarbazepine acetate monotherapy

Author

Sperling, Michael R., French, Jacqueline, Jacobson, Mercedes P., Pazdera, Ladislav, Gough, Mallory, Cheng, Hailong, Grinnell, Todd, and Blum, David

Subjects
Adult, Male, Epilepsy, Adolescent, Middle Aged, Article, Young Adult, Dibenzazepines, Humans, Anticonvulsants, Female, Aged
Abstract

Objective: To assess the efficacy and safety of eslicarbazepine acetate (ESL) monotherapy. Methods: This post hoc pooled analysis of 2 randomized double-blind studies (093-045 and -046) included adults with partial-onset seizures medically uncontrolled by 1 or 2 antiepileptic drugs (AEDs). Following the baseline period (8 weeks), eligible patients were randomized 2:1 to receive ESL 1,600 mg or 1,200 mg once daily for 18 weeks; the primary endpoint was study exit by meeting predefined exit criteria (signifying worsening seizure control). In each study, treatment was considered effective if the upper 95% confidence limit for exit rate was lower than the historical control threshold (65.3%). Results: Pooled exit rates were as follows: ESL 1,600 mg = 20.6% (95% confidence interval: 15.6%–26.8%); ESL 1,200 mg = 30.8% (23.0%–40.5%). Use of 2 baseline AEDs or rescue medication, US location, epilepsy duration ≥20 years, and higher maximum baseline seizure frequency were associated with higher exit risks. Median percent reductions in standardized seizure frequency between baseline and the 18-week double-blind period were as follows: ESL 1,600 mg = 43.2%; ESL 1,200 mg = 35.7%; baseline carbamazepine use was associated with smaller reductions. Safety profiles were similar between ESL doses. Conclusions: Exit rates for ESL monotherapy (1,600 mg and 1,200 mg once daily) were lower than the historical control threshold, irrespective of baseline AED use and region, with no additional safety concerns identified. Clinical factors and location clearly influence treatment responses in conversion-to-monotherapy trials. Classification of evidence: This pooled analysis provides Class IV evidence that for adults with medically uncontrolled partial-onset seizures, ESL monotherapy is well tolerated and effective.

Published
2016

42. Serum sodium levels and related treatment‐emergent adverse events during eslicarbazepine acetate use in adults with epilepsy

Author

Wechsler, Robert T., primary, Radtke, Rodney A., additional, Smith, Michael, additional, Vossler, David G., additional, Strom, Laura, additional, Trinka, Eugen, additional, Cheng, Hailong, additional, Grinnell, Todd, additional, Blum, David, additional, Vieira, Mariana, additional, Moreira, Joana, additional, and Rocha, Francisco, additional

Published
2019
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47. Relationship Between Adverse Event Incidence and Eslicarbazepine Acetate (ESL) Dose Across Weight Groups in Clinical Trials of Adjunctive ESL in Children (Aged 4–17 Years) with Focal Seizures (P3.5-013)

Author

Pina-Garza, Jesus E., primary, Wolf, Steven M., additional, McGoldrick, Patricia, additional, Grinnell, Todd, additional, Cantu, David, additional, Li, Yan, additional, Vieira, Mariana, additional, Ikedo, Fabio, additional, and Blum, David, additional

Published
2019
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49. Safety and Tolerability of Adjunctive Eslicarbazepine Acetate in Pediatric Patients (Aged 4-17 Years) With Focal Seizures.

Author

Mintz, Mark, Pina-Garza, Jesus E., Wolf, Steven M., McGoldrick, Patricia E., Józwiak, Sergiusz, Grinnell, Todd, Cantu, David, Costa, Raquel, Moreira, Joana, Li, Yan, and Blum, David

Subjects
SEIZURES (Medicine), MENTAL illness, ACETATES, DOSE-response relationship in biochemistry, ANTICONVULSANTS
Abstract

Objective: To evaluate the safety and tolerability of adjunctive eslicarbazepine acetate (ESL) in pediatric patients (aged 4-17 years) with refractory focal seizures. Methods: Pooled safety data from patients aged 4-17 years in Study 208 (NCT01527513) and Study 305 (NCT00988156) were analyzed. Both were randomized, double-blind, placebo-controlled studies of ESL as adjunctive treatment in pediatric patients with refractory focal seizures receiving 1 or 2 antiepileptic drugs. Incidences of treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), TEAEs leading to discontinuation, and TEAEs of special interest were evaluated. Results: The safety population comprised 362 patients (placebo, n = 160; ESL, n = 202). The overall incidence of TEAEs was similar between the ESL (67.8%) and placebo groups (65.6%), with no clear dose-response relationship. The most frequently reported TEAEs with ESL were headache, somnolence, vomiting, and diplopia. Overall incidences of SAEs and TEAEs leading to discontinuation were higher with ESL versus placebo (9.9% vs 5.0% and 5.9% vs 2.5%, respectively). The majority of SAEs with ESL occurred in Study 305. Two deaths were reported, 1 with ESL (0.5%) due to cluster seizures (resulting in herniation of the cerebellar tonsils) and 1 with placebo (0.6%) due to asphyxia. TEAEs related to allergic reaction, hyponatremia, hypothyroidism, cytopenia, seizure exacerbation, cognitive dysfunction, psychiatric disorders, or suicide occurred infrequently (<9%). Conclusion: Adjunctive ESL was generally well tolerated in children aged 4-17 years with focal seizures. The safety profile of ESL in children was comparable to that observed in adults. [ABSTRACT FROM AUTHOR]

Published
2020
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50. Safety and Tolerability of Adjunctive Eslicarbazepine Acetate (ESL) in Pediatric Patients (Aged 4–17 Years) with Partial-Onset (Focal) Seizures (POS) (P5.269)

Author

Mintz, Mark, primary, Pina-Garza, Jesus, additional, Wolf, Steven, additional, McGoldrick, Patricia, additional, Grinnell, Todd, additional, Cantu, David, additional, Costa, Raquel, additional, Moreira, Joana, additional, Li, Yan, additional, Jóźwiak, Sergiusz, additional, and Blum, David, additional

Published
2018
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