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NCT01397422 · ClinicalTrials.gov registry record · Phase 2
Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)
A Phase 2 study, sponsored by Adamas Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 83
- Enrollment target
NCT01397422: Completed Phase 2 study, sponsored by Adamas Pharmaceuticals.
NCT01397422 is a Phase 2 study that has completed, run by Adamas Pharmaceuticals. The registered enrollment target is 83 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01397422, a Phase 2 study, has completed, sponsored by Adamas Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 83 participants
- Enrollment target
Study Summary
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.
Primary Outcome
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.
Interventions
- DRUG ADS-5102 (extended release amantadine HCl)
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 83 participants |
| Start Date | 2011-07 |
| Est. Completion | 2013-10 |
| Phase | Phase 2 |
What the finished NCT01397422 record still lists
NCT01397422 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 83 participants, a relatively small participant target, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (38% lower).
The record links to 0 conditions, and to 1 intervention - of which ADS-5102 (extended release amantadine HCl) is the first listed.
NCT01397422 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT01397422 about?
NCT01397422 is a clinical study titled "Extended Release Amantadine Safety and Efficacy Study in Levodopa-Induced Dyskinesia (EASED Study)". 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 dys...
What is the current status of trial NCT01397422?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 83 participants. The study started on 2011-07. Estimated completion is 2013-10.
What interventions are being tested in trial NCT01397422?
The interventions under investigation include: ADS-5102 (extended release amantadine HCl) (DRUG).
Who is sponsoring clinical trial NCT01397422?
This trial is sponsored by Adamas Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT01397422's enrollment target sits among peer trials
83 828th of 2000 higher than 1,171 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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