This is a multi-center, randomized, double-blind, placebo-controlled, 4-arm parallel group study to evaluate the tolerability and efficacy of each of three dose levels of ADS-5102 oral capsules, an extended release formulation of amantadine, dosed once daily for the treatment of levodopa-induced dyskinesia (LID) in subjects with Parkinson's disease (PD). The novel pharmacokinetic profile of ADS-5102 is expected to achieve i) higher amantadine plasma concentrations during daytime hours when dyskinesia as well as motor and non-motor symptoms of PD are most problematic, ii) low amantadine plasma concentrations overnight, which may reduce the sleep disturbances and vivid dreams occasionally associated with amantadine, and iii) a reduced initial rate of rise in plasma concentration, which is expected to improve overall tolerability of amantadine.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
83
Oral capsules to be administered once daily at bedtime, for 8 weeks
Unnamed facility
Sun City, Arizona, United States
Unnamed facility
Fountain Valley, California, United States
Unnamed facility
Long Beach, California, United States
Unnamed facility
Los Angeles, California, United States
Unnamed facility
Oxnard, California, United States
Unnamed facility
Pasadena, California, United States
Unnamed facility
Reseda, California, United States
Unnamed facility
Sunnyvale, California, United States
Unnamed facility
Ventura, California, United States
Unnamed facility
Fairfield, Connecticut, United States
...and 23 more locations
Change in the Unified Dyskinesia Rating Scale (UDysRS) Total Score From Baseline to Week 8
The UDysRS is a dyskinesia rating scale from 0-104, and it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The last observation carried forward (LOCF) method was used for analysis. Participants were summarized according to the actual treatment received.
Time frame: Baseline (Day 1) and Week 8
Change in the Fatigue Severity Score (FSS) From Baseline to Week 8
The FSS is a 9-item self-reported scale, rating subject experience of fatigue during the previous 7 days. The total score, on a scale from 1-7, is represented by the mean of all answered items. The higher the score, the greater the fatigue severity.
Time frame: Baseline (Day 1) and Week 8
Change in Total Objective Score (III, IV) of the UDysRS From Baseline to Week 8
UDysRS Part III measures objective impairment (dyskinesia severity, anatomic distribution, and type, based on 4 observed activities); and Part IV measures objective disability based on Part III activities. The scores for the 2 Parts combined range from 0-44; a higher score represents more severe dyskinesia.
Time frame: Baseline (Day 1) and Week 8
Change in ON Time Without Troublesome Dyskinesia (ON Without Dyskinesia Plus ON With Non-troublesome Dyskinesia) From Baseline to Week 8; Based on a Standardized PD Home Diary
A PD home diary was used to score 5 different conditions in 30-minute time intervals: ASLEEP, OFF, ON (ie, had adequate control of PD symptoms) without dyskinesia, ON with non-troublesome dyskinesia, and ON with troublesome dyskinesia. The results were based on 2 consecutive 24-hour diaries taken prior to the day of randomization and prior to the Week 8 visit.
Time frame: Baseline (Day 1) and Week 8
Change in Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Combined Scores (Parts I, II, III) From Baseline to Week 8
The MDS-UPDRS Parts I, II, and III examined non-motor experiences of daily living, motor experiences of daily living, and motor examination, respectively. Each part had sub scales ranging from normal = 0 to severe = 4.
Time frame: Baseline (Day 1) and Week 8
Clinician's Global Impression of Change (CGI-C) in Overall PD Symptoms From Baseline to Week 8
The CGI-C consisted of a single question that assessed the investigator's global impression of the subject's change from Baseline in overall PD symptoms, including but not limited to LID. The CGI-C required that the investigator rate the extent to which the subject's PD had improved or worsened (from marked worsening to marked improvement).
Time frame: Baseline (Day 1) and Week 8
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