Session Information
Date: Monday, September 23, 2019
Session Title: Clinical Trials, Pharmacology and Treatment
Session Time: 1:45pm-3:15pm
Location: Agora 3 West, Level 3
Objective: To assess the impact of Gocovri® (amantadine) extended release capsules on motor aspects of experiences of daily living in PD patients.
Background: Gocovri is the only FDA-approved treatment of dyskinesia for PD patients taking levodopa therapy, with demonstrated significant reduction in dyskinesia and OFF time in two phase 3 trials. Part II of the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) is a patient-reported, 13-item measure assessing disability in motor aspects of experiences of daily living (m-EDLs); each item is anchored and rates disability from none (0) to severe (4). A change of at least 2 points in the MDS-UPDRS Part II is reported to be clinically important.
Method: Baseline to week 12 changes in the total and the individual item scores for MDS-UPDRS Part II were compared for Gocovri and placebo using pooled data from both phase 3 trials.
Results: Baseline mean MDS-UPDRS Part II total score was 15.1 for Gocovri (n=97) and 15.3 for placebo (n=90) and at week 12, the LS Mean change from baseline was -3.4 and -1.4 for Gocovri and placebo, respectively. The placebo-adjusted treatment difference was -2.0 (95% CI of -3.34, -0.66; P<.004). Improvement was driven primarily by reduction in four m-EDLs: freezing, tremor, getting out of bed/car/deep chair, and eating tasks. For these respective items, the placebo-corrected differences were: -0.4, -0.4, -0.3, -0.2 (P<.0001, P=.002, P=.002, P=.02).
Conclusion: These post-hoc analyses of patient-reported data (MDS-UPDRS Part II) suggest that Gocovri may improve freezing, tremor, and other motor aspects of experiences of daily living. Since the MDS-UPDRS asks patients about their average or usual function over the past week, further studies should be considered to confirm these findings and explore whether they reflect decreased OFF time, or improved function during ON and/or OFF time.
To cite this abstract in AMA style:
R. Hauser, D. Kremens, D. Chernick, R. Patni, J. Hubble. The Effect of Gocovri on Motor Aspects of Experiences of Daily Living: Analyses of MDS-UPDRS Part II Data from a Phase 3 Program [abstract]. Mov Disord. 2019; 34 (suppl 2). https://www.mdsabstracts.org/abstract/the-effect-of-gocovri-on-motor-aspects-of-experiences-of-daily-living-analyses-of-mds-updrs-part-ii-data-from-a-phase-3-program/. Accessed May 12, 2025.« Back to 2019 International Congress
MDS Abstracts - https://www.mdsabstracts.org/abstract/the-effect-of-gocovri-on-motor-aspects-of-experiences-of-daily-living-analyses-of-mds-updrs-part-ii-data-from-a-phase-3-program/