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4. Patients’ Preferences for Adjunctive Parkinson’s Disease Treatments: A Discrete-Choice Experiment

Author

Serbin,Michael, Marras,Connie, Mansfield,Carol, Leach,Colton, Yonan,Charles, Sheehan,Margaret, Donnelly,Anne, Klepitskaya,Olga, Serbin,Michael, Marras,Connie, Mansfield,Carol, Leach,Colton, Yonan,Charles, Sheehan,Margaret, Donnelly,Anne, and Klepitskaya,Olga

Abstract

Michael Serbin,1 Connie Marras,2 Carol Mansfield,3 Colton Leach,3 Charles Yonan,1 Margaret Sheehan,4 Anne Donnelly,5 Olga Klepitskaya1 1Neurocrine Biosciences, Inc., San Diego, CA, USA; 2The Edmond J. Safra Program in Parkinson’s Disease, University Health Network, University of Toronto, Toronto, ON, Canada; 3RTI Health Solutions, Research Triangle Park, NC, USA; 4Ashurst, Washington, DC, USA; 5Kellogg School of Management, Northwestern University, Evanston, IL, USACorrespondence: Carol Mansfield, RTI Health Solutions, 3040 East Cornwallis Road, PO Box 12194, Research Triangle Park, NC, 27709, USA, Tel +19195418053, Email carolm@rti.orgBackground: Several adjunctive medications are available to reduce OFF time between levodopa/carbidopa (LD/CD) doses for people with Parkinson’s disease (PD).Objective: To explore how individuals with PD balance benefits and burdens when considering adjunctive medications.Methods: US adults (30– 83 years) with self-reported PD, currently treated with LD/CD, who experienced OFF episodes were recruited through the Fox Insight study to complete a discrete-choice experiment survey. Respondents selected among experimentally designed profiles for hypothetical adjunctive PD treatments that varied in efficacy (additional ON time), potential adverse effects (troublesome dyskinesia, risk of diarrhea, risk of change in bodily fluid color), and dosing frequency or the option “No additional medicine”. Data were analyzed with random-parameters logit models.Results: Respondents (N=480) would require ≥ 60 additional minutes of daily ON time to accept either a 40% risk of change in bodily fluid color or 10 additional minutes with troublesome dyskinesia daily. Respondents would require 40 additional minutes of daily ON time to accept a 10% risk of diarrhea and 22 additional minutes of daily ON time to switch from 1 additional pill each day to 1 pill with each LD/CD dose. On average, respondents preferred adjunctive PD medication over no add

Published
2023

7. Clinician Perceptions of the Negative Impact of Telehealth Services in the Management of Drug-Induced Movement Disorders and Opportunities for Quality Improvement: A 2021 Internet-Based Survey

Author

Bera,Rimal, Bron,Morgan, Benning,Betsy, Cicero,Samantha, Calara,Heintje, Darling,Diane, Franey,Ericha, Martello,Kendra, Yonan,Charles, Bera,Rimal, Bron,Morgan, Benning,Betsy, Cicero,Samantha, Calara,Heintje, Darling,Diane, Franey,Ericha, Martello,Kendra, and Yonan,Charles

Abstract

Rimal Bera,1 Morgan Bron,2 Betsy Benning,3 Samantha Cicero,4 Heintje Calara,2 Diane Darling,2 Ericha Franey,2 Kendra Martello,5 Charles Yonan2 1Irvine Medical Center, University of California, Orange, CA, USA; 2Health Economics and Outcomes Research, Neurocrine Biosciences, Inc., San Diego, CA, USA; 3Emerging Biopharma, IQVIA Inc., Danbury, CT, USA; 4Field Medical Affairs, Neurocrine Biosciences, Inc., San Diego, CA, USA; 5Public Policy, Neurocrine Biosciences, Inc., San Diego, CA, USACorrespondence: Rimal Bera, Irvine Medical Center, University of California, 101 City Drive, Orange, CA, 92618, USA, Tel +1-714-456-6898, Fax +1-714-456-5112, Email rbera@hs.uci.eduPurpose: Tardive dyskinesia (TD) is a drug-induced movement disorder (DIMD) seen in patients taking dopamine-receptor blocking agents (DRBAs). Clinicians should regularly monitor patients with or at risk of developing DIMDs; however, telehealth visits during the COVID-19 pandemic presented several significant challenges related to screening and care of these patients. In this observational survey study, respondents compared in-person with video/telephone visits to determine the impact on the evaluation, diagnosis, and monitoring of patients with DIMDs.Methods: The online survey was conducted (May 14–June 21, 2021) with qualified clinicians who prescribed a vesicular monoamine transporter 2 inhibitor or benztropine for DIMDs in the past 6 months, spent ≤ 70% of their professional time in the clinic, and conducted telehealth visits with ≥ 15% of their patients between December 2020 and January 2021. The questionnaire probed clinicians about their ability to evaluate, diagnose and monitor (hereinafter referred to as manage) patients with DIMDs via telehealth.Results: Survey respondents included 277 clinicians from psychiatry (n = 168) and neurology (n = 109) practices. Certain signs and symptoms (visual cues) used for diagnosis of DIMDs were not observable through telehealth and evaluation was comparative

Published
2022

9. Growth-Related Characteristics of Patients <18 Years of Age with Congenital Adrenal Hyperplasia Due to 21-Hydroxylase Deficiency (21OHD): Real World Evidence from the I-CAH Registry

Author

Farrar, Mallory, primary, Ali, Salma Rashid, additional, Bryce, Jillian, additional, Baronio, Federico, additional, Claahsen-van der Grinten, Hedi L, additional, Bonfig, Walter, additional, Yonan, Charles, additional, Farber, Robert, additional, Chan, Jean Lin, additional, and Ahmed, S Faisal, additional

Published
2021
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14. Erratum to: PRISM II: an open-label study to assess effectiveness of dextromethorphan/quinidine for pseudobulbar affect in patients with dementia, stroke or traumatic brain injury

Author

Hammond, Flora M., primary, Alexander, David N., additional, Cutler, Andrew J., additional, D’Amico, Stephen, additional, Doody, Rachelle S., additional, Sauve, William, additional, Zorowitz, Richard D., additional, Davis, Charles S., additional, Shin, Paul, additional, Ledon, Fred, additional, Yonan, Charles, additional, Formella, Andrea E., additional, and Siffert, Joao, additional

Published
2016
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15. PRISM II: an open-label study to assess effectiveness of dextromethorphan/quinidine for pseudobulbar affect in patients with dementia, stroke or traumatic brain injury

Author

Hammond, Flora M., primary, Alexander, David N., additional, Cutler, Andrew J., additional, D’Amico, Stephen, additional, Doody, Rachelle S., additional, Sauve, William, additional, Zorowitz, Richard D., additional, Davis, Charles S., additional, Shin, Paul, additional, Ledon, Fred, additional, Yonan, Charles, additional, Formella, Andrea E., additional, and Siffert, Joao, additional

Published
2016
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17. PRISM II: Effectiveness of Dextromethorphan 20 mg/Quinidine 10 mg (NUEDEXTA®) for Treatment of Pseudobulbar Affect Secondary to Dementia, Stroke, or Traumatic Brain Injury: Combined Results of a Multicenter Open-Label Study (P2.225)

Author

Siffert, Joao, primary, Hammond, Flora, additional, Alexander, David, additional, Cutler, Andrew, additional, D'Amico, Stephen, additional, Doody, Rachelle, additional, Sauve, William, additional, Zorowitz, Richard, additional, Davis, Charles, additional, Shin, Paul, additional, Ledon, Fred, additional, Yonan, Charles, additional, and Formella, Andrea, additional

Published
2016
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18. An Open-Label Study to Assess Safety, Tolerability, and Effectiveness of Dextromethorphan/Quinidine for Pseudobulbar Affect (PBA) in Dementia, Stroke and Traumatic Brain Injury: PRISM II Combined Cohort Results for Patients Aged ≥65 Years

Author

Hammond, Flora, primary, Alexander, David N., additional, Cutler, Andrew J., additional, D'Amico, Stephen, additional, Doody, Rachelle S., additional, Sauve, William, additional, Zorowitz, Richard D., additional, Davis, Charles S., additional, Shin, Paul, additional, Ledon, Fred, additional, Yonan, Charles, additional, Formella, Andrea E., additional, and Siffert, Joao, additional

Published
2016
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28. PRISM II: An Open-Label Study to Assess the Safety, Tolerability, and Effectiveness of Dextromethorphan 20 mg/Quinidine 10 mg for Treatment of Pseudobulbar Affect Secondary to Dementia, Stroke, or Traumatic Brain Injury: Results from the Alzheimer’s Disease/Dementia Cohort (P7.109)

Author

Doody, Rachelle, primary, D'Amico, Stephen, additional, Cutler, Andrew, additional, Shin, Paul, additional, Ledon, Fred, additional, Yonan, Charles, additional, and Siffert, Joao, additional

Published
2015
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29. PRISM II: An Open-Label Study to Assess the Safety, Tolerability, and Effectiveness of Dextromethorphan 20 mg/Quinidine 10 mg for Treatment of Pseudobulbar Affect Secondary to Dementia, Stroke, or Traumatic Brain Injury: Results from the Alzheimer's Disease/Dementia Cohort

Author

Doody, Rachelle S., primary, D'Amico, Stephen, additional, Cutler, Andrew J., additional, Shin, Paul, additional, Ledon, Frederic, additional, Yonan, Charles, additional, and Siffert, Joao, additional

Published
2015
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35. Poster Number: NR 15 - An Open-Label Study to Assess Safety, Tolerability, and Effectiveness of Dextromethorphan/Quinidine for Pseudobulbar Affect (PBA) in Dementia, Stroke and Traumatic Brain Injury: PRISM II Combined Cohort Results for Patients Aged ≥65 Years

Author

Hammond, Flora, Alexander, David N., Cutler, Andrew J., D'Amico, Stephen, Doody, Rachelle S., Sauve, William, Zorowitz, Richard D., Davis, Charles S., Shin, Paul, Ledon, Fred, Yonan, Charles, Formella, Andrea E., and Siffert, Joao

Published
2016
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37. Prevalence of pseudobulbar affect symptoms and clinical correlates in nursing home residents.

Author

Foley, Kevin, Konetzka, R. Tamara, Bunin, Anthony, and Yonan, Charles

Subjects
NEUROLOGICAL disorders, DISEASE prevalence, GERIATRIC assessment, FUNCTIONAL loss in older people, PSYCHOLOGICAL testing of older people, ANTIPSYCHOTIC agents, PSYCHIATRIC drugs, AFFECTIVE disorders, CRYING, LAUGHTER, NURSING care facilities, RETROSPECTIVE studies, DISEASE complications
Abstract

Objective: Pseudobulbar affect (PBA) is a neurological disorder of emotional expression, characterized by uncontrollable episodes of crying or laughing in patients with certain neurological disorders affecting the brain. The purposes of this study were to estimate the prevalence of PBA in US nursing home residents and examine the relationship between PBA symptoms and other clinical correlates, including the use of psychopharmacological medications.Methods: A retrospective study was conducted between 2013 and 2014 with a convenience sample of residents from nine Michigan nursing homes. Chronic-care residents were included in the "predisposed population" if they had a neurological disorder affecting the brain and no evidence of psychosis, delirium, or disruptive behavior (per chart review). Residents were screened for PBA symptoms by a geropsychologist using the Center for Neurologic Study-Lability Scale (CNS-LS). Additional clinical information was collected using a diagnostic evaluation checklist and the most recent Minimum Data Set 3.0 assessment.Results: Of 811 residents screened, complete data were available for 804, and 412 (51%) met the criteria for the "predisposed population." PBA symptom prevalence, based on having a CNS-LS score ≥13, was 17.5% in the predisposed population and 9.0% among all nursing home residents. Those with PBA symptoms were more likely to have a documented mood disorder and be using a psychopharmacological medication, including antipsychotics, than those without PBA symptoms.Conclusions: Pseudobulbar affect symptoms were present in 17.5% of nursing home residents with neurological conditions, and 9.0% of residents overall. Increasing awareness and improving diagnostic accuracy of PBA may help optimize treatment. Copyright © 2015 John Wiley & Sons, Ltd. [ABSTRACT FROM AUTHOR]

Published
2016
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45. An open-label study to assess safety, tolerability, and effectiveness of dextromethorphan/quinidine for pseudobulbar affect in dementia: PRISM II results

Author

Doody, Rachelle S., D’Amico, Stephen, Cutler, Andrew J., Davis, Charles S., Shin, Paul, Ledon, Fred, Yonan, Charles, and Siffert, João

Abstract

BackgroundDextromethorphan (DM)/quinidine (Q) is an approved treatment for pseudobulbar affect (PBA) based on trials in amyotrophic lateral sclerosis or multiple sclerosis. PRISM II evaluated DM/Q effectiveness and tolerability for PBA secondary to dementia, stroke, or traumatic brain injury; dementia cohort results are reported.MethodsThis was an open-label, multicenter, 90 day trial; patients received DM/Q 20/10 mg twice daily. Primary outcome was change in Center for Neurologic Study–Lability Scale (CNS-LS) score. Secondary outcomes included PBA episode count and Clinical and Patient/Caregiver Global Impression of Change scores with respect to PBA (CGI-C/PGI-C).Results134 patients were treated. CNS-LS improved by a mean (SD) of 7.2 (6.0) points at Day 90/Endpoint (P<.001) vs. baseline. PBA episodes were reduced 67.7% (P<.001) vs. baseline; global measures showed 77.5% CGI-C and 76.5% PGI-C “much”/”very much” improved. Adverse events included headache (7.5%), urinary tract infection (4.5%), and diarrhea (3.7%); few patients dropped out for adverse events (10.4%).ConclusionsDM/Q significantly reduced PBA symptoms in patients with dementia; reported adverse events were consistent with the known safety profile of DM/Q.Trial Registrationclinicaltrials.gov identifier: NCT01799941.

Published
2016
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