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NCT02153632 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LID
A Phase 3 study, sponsored by Adamas Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 135
- Enrollment target
NCT02153632: Clinical Trial Phase 3 study, sponsored by Adamas Pharmaceuticals.
NCT02153632 is a Phase 3 study that was terminated before completion, run by Adamas Pharmaceuticals. The registered enrollment target is 135 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02153632, a Phase 3 study, was terminated before completion, sponsored by Adamas Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 135 participants
- Enrollment target
Study Summary
The purpose of this multi-center, randomized, double-blind, parallel-group, 26 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.
Primary Outcome
The Unified Dyskinesia Rating Scale is a validated tool for assessment of dyskinesia (involuntary movements) in Parkinson's Disease patients. Rating consists of the change from baseline to Day 98 of the sum of the 26 questions comprising the questionnaire. Each question in the questionnaire is rated on a 5 point scale from 0-4 where 0 is a better outcome. Questions assess: over the past week total hours with dyskinesia and total hours without dyskinesia; problems with speech, chewing and swallow
Interventions
- DRUG Placebo
- DRUG amantadine HCl ER
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 135 participants |
| Start Date | 2014-07-30 |
| Est. Completion | 2016-05-20 |
| Phase | Phase 3 |
Why NCT02153632 stopped before completion
NCT02153632 is an interventional study that assigns participants to a tested intervention. The registered 135 participants enrollment target is mid-sized for trials with a published cap, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (83% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT02153632 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02153632 about?
NCT02153632 is a clinical study titled "Efficacy and Safety of Amantadine Hydrogen Chloride (HCl) ER Tablets in Parkinson's Disease Subjects With LID". The purpose of this multi-center, randomized, double-blind, parallel-group, 26 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to placebo for the treatment of levodopa induced dyskinesia in patients with Parkinson's disease.
What is the current status of trial NCT02153632?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 135 participants. The study started on 2014-07-30. Estimated completion is 2016-05-20.
What interventions are being tested in trial NCT02153632?
The interventions under investigation include: Placebo (DRUG), amantadine HCl ER (DRUG).
Who is sponsoring clinical trial NCT02153632?
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 NCT02153632's enrollment target sits among peer trials
135 1582nd of 2000 higher than 416 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 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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