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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 is a Phase 3 study that was terminated before completion, run by Adamas Pharmaceuticals. The registered enrollment target is 87 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02153645
The ClinicalTrials.gov registry entry for NCT02153645 describes a study currently listed as terminated, categorized as Phase 3. The registered enrollment target is 87 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Adamas Pharmaceuticals, which has 10 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 3 interventions - of which Placebo tablets is the first listed.
NCT02153645 reports 0 study locations.
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.
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