Effects of Gocovri (Amantadine) Extended-Release Capsules on Motor Aspects of Experiences of Daily Living in People with Parkinson’s Disease and Dyskinesia

Robert A. Hauser, Shyamal H. Mehta, Daniel Kremens, Dustin Chernick, Andrea E. Formella

Research output: Contribution to journalArticlepeer-review

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’s disease (PD). Part II of the Movement Disorder Society Unified Parkinson’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.

Original languageEnglish (US)
JournalNeurology and Therapy
DOIs
StateAccepted/In press - 2021

Keywords

  • Amantadine extended release
  • Experiences of daily living
  • Gocovri
  • MDS-UPDRS
  • Motor complications
  • Parkinson’s disease
  • Treatment

ASJC Scopus subject areas

  • Neurology
  • Clinical Neurology

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