@article{d6e1ff0826a14f769fe909457ac938fb,
title = "Effects of Gocovri (Amantadine) Extended-Release Capsules on Motor Aspects of Experiences of Daily Living in People with Parkinson{\textquoteright}s Disease and Dyskinesia",
abstract = "Introduction: Gocovri, a bedtime-administered delayed-release/extended-release capsule formulation of amantadine, is the only drug approved by the US Food and Drug Administration as levodopa-adjunctive therapy for the treatment of OFF episodes and/or dyskinesia in Parkinson{\textquoteright}s disease (PD). Part II of the Movement Disorder Society Unified Parkinson{\textquoteright}s Disease Rating Scale (MDS-UPDRS) assesses patient-perceived disability on experiences of daily living affected by PD motor symptoms. We analyzed Gocovri-related changes in MDS-UPDRS Part II ratings in two placebo-controlled clinical trials. Methods: Baseline to week 12 changes in MDS-UPDRS Part II total and item scores were compared for Gocovri and placebo using pooled data from phase 3 trials (EASE LID and EASE LID 3). Results: Baseline mean MDS-UPDRS Part II total score was 15.1 for Gocovri (n = 100) and 15.3 for placebo (n = 96) groups. At week 12, the least squares mean change from baseline was −3.4 for the Gocovri group and −1.4 for placebo (treatment difference, −2.0; 95% CI −3.3 to −0.7; P = 0.004). For Gocovri, change from baseline exceeded a published minimal clinically important difference threshold of 3.05. Gocovri-related treatment differences over placebo were driven primarily by improvement in the scale items of freezing (−0.4; P < 0.0001), tremor (−0.4; P = 0.002), getting out of bed/car/deep chair (−0.3; P = 0.002), and eating tasks (−0.2; P = 0.016). Conclusion: In addition to improvement in dyskinesia, Gocovri-treated participants experienced improvement in motor aspects of experiences of daily living. Analyses suggest that Gocovri may specifically improve freezing, tremor, getting out of bed/car/deep chair, and eating tasks. Trial Registration: ClinicalTrials.gov identifiers: NCT02136914, NCT02274766.",
keywords = "Amantadine extended release, Experiences of daily living, Gocovri, MDS-UPDRS, Motor complications, Parkinson{\textquoteright}s disease, Treatment",
author = "Hauser, {Robert A.} and Mehta, {Shyamal H.} and Daniel Kremens and Dustin Chernick and Formella, {Andrea E.}",
note = "Funding Information: RAH: Consulting fees from Acadia Pharmaceuticals, Acorda Therapeutics, Adamas Pharmaceuticals, Affiris AG, Alliance for Aging Research, Alphasights, Amneal Pharmaceuticals Inc, ApoPharma, Aranca, Cadent Therapeutics, Cerespir Inc, CNS Ratings LLC, Defined Health, Enterin Inc, Extera Partners, Gerson Lehrman Group (GLG), Global Kinetics Corporation, Impax Laboratories, Impel Neuropharma, Inhibikase, International Stem Cell Corporation, Jazz Pharmaceutics, Kaiser, Kashiv Pharma LLC, Kyowa Kirin Pharmaceutical Development, L.E.K. Consulting, Lundbeck, Lundbeck A/S, Medscape, Michael J. Fox Foundation, Mitsubishi Tanabe Pharmaceuticals, Neuro Challenge Foundation for Parkinson{\textquoteright}s, Neurocrine Biosciences, Northwestern University, Parkinson{\textquoteright}s Foundation, Parkinson{\textquoteright}s Study Group, Pennside Partners, Perception OpCo, Seelos Therapeutics, Slingshot Insights, Sunovion Pharmaceuticals Inc, Teva Pharmaceuticals, US WorldMeds, and WebMD. Research support from AbbVie Inc, Acorda Therapeutics, AstraZeneca, Axovant Sciences, Biogen Inc., Cavion, Enterin Inc, Impax Laboratories, LLC, Intec Pharma Ltd, Jazz Pharmaceuticals, NeuroDerm Ltd, Lundbeck, Michael J. Fox Foundation for Parkinson{\textquoteright}s Research, F. Hoffman-La Roche, Dart NeuroScience LLC, Prexton Therapeutics, Revance Therapeutics Inc, Sunovion Pharmaceuticals. Grant support from Parkinson{\textquoteright}s Foundation. Stock ownership in Inhibikase Therapeutics Inc and Axial Biotherapeutics. SHM: Consultant for Adamas Pharmaceuticals, CNS Ratings, and Abbott. Grant support from Arizona Biomedical Research Commission (ABRC) Grant ADHS 16-162411, International Essential Tremor Foundation (IETF) Grant, Eli Lilly, Pharma2B and Neuraly. DK: Consultant and speaker bureau member for Acadia, Adamas, Impax, Lundbeck, Teva, UCB, and US WorldMeds; consultant for AbbVie, Allergan, GE Healthcare, Kyowa, Merz, Neurocrine, St. Jude Medical, and Sunovion; researcher for Enterin and Revance; and researcher and consultant for Acorda. DC is a former employee of Adamas Pharmaceuticals, Inc, and owns stock in Adamas. AF is an employee of and owns stock in Adamas Pharmaceuticals, Inc. Funding Information: Editorial assistance in the preparation of this manuscript was provided by Robin Smith, PhD, of The Curry Rockefeller Group, LLC; support for this assistance was funded by Adamas Pharmaceuticals. Judy Lytle, PhD, of Adamas Pharmaceuticals, Inc., provided publication management; Lily Llorens, PhD, provided statistical consultation and review; Rob Howard of Veridical Solutions provided data analysis; Reed Johnson provided study management and was a consultant on the statistical plan. Publisher Copyright: {\textcopyright} 2021, The Author(s).",
year = "2021",
month = dec,
doi = "10.1007/s40120-021-00256-1",
language = "English (US)",
volume = "10",
pages = "739--751",
journal = "Neurology and Therapy",
issn = "2193-8253",
publisher = "Springer Healthcare",
number = "2",
}