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NCT02136914 · ClinicalTrials.gov registry record · Phase 3
ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)
A Phase 3 study, sponsored by Adamas Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 126
- Enrollment target
NCT02136914 is a Phase 3 study that has completed, run by Adamas Pharmaceuticals. The registered enrollment target is 126 participants.
The verdict
NCT02136914, a Phase 3 study, has completed, sponsored by Adamas Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 126 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime 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) maximal concentrations in the early morning through mid-day, when LID can be troublesome, and ii) lower concentrations in the evening, potentially reducing the negative impact of amantadine on sleep. This pharmacokinetic profile could enable higher doses to be tolerated with a once-nightly ER formulation than can be tolerated with an immediate-release formulation. The once-nightly dosing regimen may also provide enhanced convenience and compliance. In a previous clinical study, ADS-5102 met its primary endpoint; LID was significantly reduced as measured by the change in UDysRS score over 8 weeks vs. placebo.
Interventions
- OTHER Placebo
- DRUG ADS-5102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 126 participants |
| Start Date | 2014-05 |
| Est. Completion | 2015-12 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02136914
The ClinicalTrials.gov registry entry for NCT02136914 describes a study currently listed as completed, categorized as Phase 3. The registered enrollment target is 126 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 2 interventions - of which Placebo is the first listed.
NCT02136914 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02136914 about?
NCT02136914 is a clinical study titled "ADS-5102 for the Treatment of Levodopa Induced Dyskinesia (EASE LID Study)". This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study to evaluate the efficacy and safety of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once nightly at bedtime for the treatment of levodopa induced dyskines...
What is the current status of trial NCT02136914?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 126 participants. The study started on 2014-05. Estimated completion is 2015-12.
What interventions are being tested in trial NCT02136914?
The interventions under investigation include: Placebo (OTHER), ADS-5102 (DRUG).
Who is sponsoring clinical trial NCT02136914?
This trial is sponsored by Adamas Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov.
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