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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 is a Phase 2 study that has completed, run by Adamas Pharmaceuticals. The registered enrollment target is 83 participants.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT01397422
The ClinicalTrials.gov registry entry for NCT01397422 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 83 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 1 intervention - of which ADS-5102 (extended release amantadine HCl) is the first listed.
NCT01397422 reports 0 study locations.
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.
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