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 language | English (US) |
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Pages (from-to) | 739-751 |
Number of pages | 13 |
Journal | Neurology and Therapy |
Volume | 10 |
Issue number | 2 |
DOIs | |
State | Published - Dec 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