Objective: To assess the impact of dyskinesias in PD on ADLs and the effects of ADS-5102 (amantadine) extended release capsules on these impairments.

Background: ADS-5102 (GOCOVRI, Adamas Pharmaceuticals, Inc.) is a treatment for dyskinesia in patients with Parkinson’s disease (PD). ADS-5102 reduced dyskinesia and OFF time in two phase 3 controlled trials. Dyskinesia has been found to heighten the negative impact of PD on a patient’s quality of life.

Methods: Results presented here pertain to pooled data from the Unified Dyskinesia Rating Scale (UDysRS) Parts 1B and Part 3, obtained at baseline and at Week 12. Part 1B of the UDysRS is a patient-reported questionnaire focused on the impact of dyskinesias on ADLs. In Part 3, clinicians assess how intense the dyskinesia is in each body part while performing a daily task communication, drinking from a cup, dressing and ambulation).

Results: At baseline, the proportion of subjects reporting at least mild impairment on ADLs due to their dyskinesia was highest for walking and balance (73%) and public and social settings (72%). It was lowest for chewing and swallowing (18%). Across all four daily tasks assessed in UDysRS Part 3, among the body parts exhibiting at least moderate dyskinesia-related impairment (i.e., a score ≥2) the trunk was most frequently involved (62% of patients), and the face least commonly (35%). At Week 12, a greater proportion of ADS-5102 treated patients improved with all ADLs in Part 1B with statistically significant difference in six out of 10 (speech, walking and balance, doing hobbies, eating tasks, public and social settings, and excited and emotional settings). All seven body parts measured in Part 3 demonstrated a statistically significant shift to improvement for ADS-5102 over placebo. The most common adverse events reported included hallucinations, dry mouth, dizziness, and peripheral edema.

Conclusions: Dyskinesia has a remarkable impact on patients’ activities of daily living and while intensity of dyskinesia was most prominent in the trunk, it occurred throughout the body in this population. Patients treated with ADS-5102 showed greater improvement across all ADLs and each body part during daily tasks compared to placebo. Safety data has been previously reported for this population, with the most common adverse events reported included hallucinations, dry mouth, dizziness, and peripheral edema.

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MDS Abstracts - https://www.mdsabstracts.org/abstract/impact-of-dyskinesia-in-parkinsons-disease-pd-on-activities-of-daily-living-adls-and-daily-tasks-results-from-pooled-phase-3-ads-5102-clinical-trials/