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NCT02153645 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID.
A Phase 3 study, sponsored by Adamas Pharmaceuticals.
- Terminated
- Registry status
- Phase 3
- Development phase
- 87
- Enrollment target
NCT02153645: Clinical Trial Phase 3 study, sponsored by Adamas Pharmaceuticals.
NCT02153645 is a Phase 3 study that was terminated before completion, run by Adamas Pharmaceuticals. The registered enrollment target is 87 participants, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02153645, a Phase 3 study, was terminated before completion, sponsored by Adamas Pharmaceuticals.
- TERMINATED
- Registry status
- Phase 3
- Development phase
- 87 participants
- Enrollment target
Study Summary
This study was terminated early due to slow enrollment with 87 of 162 planned subjects enrolled. The purpose of this multi-center, randomized, double-blind, parallel-group, 16 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 tablets
- DRUG 240mg Amantadine HCl ER tablets
- DRUG 320mg Amantadine HCl ER tablets
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 87 participants |
| Start Date | 2014-08-18 |
| Est. Completion | 2016-05-20 |
| Phase | Phase 3 |
Why NCT02153645 stopped before completion
NCT02153645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 87 participants, a relatively small participant target, below the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (89% lower).
The record links to 0 conditions, and to 3 interventions - of which Placebo tablets is the first listed.
NCT02153645 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT02153645 about?
NCT02153645 is a clinical study titled "Efficacy and Safety of Amantadine Hydrochloride (HCl) ER Tablets to Treat Parkinson's Disease Patients With LID.". This study was terminated early due to slow enrollment with 87 of 162 planned subjects enrolled. The purpose of this multi-center, randomized, double-blind, parallel-group, 16 week study is to compare the efficacy and safety of two different dose levels of Amantadine Extended Release Tablets to plac...
What is the current status of trial NCT02153645?
This trial is currently terminated. It is a Phase 3 study. The enrollment target is 87 participants. The study started on 2014-08-18. Estimated completion is 2016-05-20.
What interventions are being tested in trial NCT02153645?
The interventions under investigation include: Placebo tablets (DRUG), 240mg Amantadine HCl ER tablets (DRUG), 320mg Amantadine HCl ER tablets (DRUG).
Who is sponsoring clinical trial NCT02153645?
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 NCT02153645's enrollment target sits among peer trials
87 1742nd of 2000 higher than 256 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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