At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 223 enrolled
Drug / intervention
ADS-5102drug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
Open-Label Safety Study of ADS-5102 (Amantadine HCl) Extended Release Capsules for the Treatment of Levodopa Induced Dyskinesia (LID)
In Brief
A Phase 3 clinical trial evaluating ADS-5102 for Dyskinesia and 2 related conditions. Completed, enrolled 223 participants across 87 sites in 6 countries.
Detailed Summary
This is a 105-week open-label study to evaluate the safety and tolerability of ADS-5102 oral capsules, an extended release formulation of amantadine, in Parkinson's Disease (PD) patients with Levodopa Induced Dyskinesia (LID).
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesAustria, Canada, France, Germany, Spain, United States
Collaborators--
Timeline
Phase 3CompletedFinished
201520162017201820192020202120222023202420252026
Enrollment StartJul 2014
First PostedJul 2014
Primary CompletionFeb 2018
TodayJul 2026
First PostedJul 29, 2014
Enrollment StartJul 1, 2014
Primary CompletionFeb 1, 2018
TodayJul 2, 2026
Enrollment to primary: 3.6 yearsPosted 11.9 years ago
Interventions
ADS-5102drug