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NCT02274766 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia
A Phase 3 study of Parkinsons Disease (PD) and Dyskinesia, sponsored by Adamas Pharmaceuticals.
- Completed
- Registry status
- Phase 3
- Development phase
- 77
- Enrollment target
- 20
- Study locations
NCT02274766: Completed Phase 3 study of Parkinsons Disease (PD) and Dyskinesia, sponsored by Adamas Pharmaceuticals.
NCT02274766 is a Phase 3 study of Parkinsons Disease (PD) and Dyskinesia that has completed, run by Adamas Pharmaceuticals. The registered enrollment target is 77 participants, below the 115-participant average among 19 other Parkinsons Disease (PD) trials with a reported enrollment target (33% lower). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT02274766, a Phase 3 study of Parkinsons Disease (PD) and Dyskinesia, has completed, sponsored by Adamas Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 77 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The UDysRS is a dyskinesia rating scale from 0-104; it evaluates involuntary movements associated with PD. A higher score indicates more severe PD. The UDysRS was measured at Baseline and Weeks 2, 4, 8, and 12.
Conditions Studied
Interventions
- OTHER Placebo
- DRUG ADS-5102
Study Locations (20)
Florida
- - Boca Raton
- - Jacksonville
- - Port Charlotte
- - Sunrise
- - Tampa
California
- - Fountain Valley
- - Sunnyvale
Maryland
- - Baltimore
- - Elkridge
North Carolina
- - Greensboro
- - Raleigh
Georgia
- - Atlanta
Illinois
- - Chicago
Kansas
- - Kansas City
Massachusetts
- - Boston
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 77 participants |
| Start Date | 2014-10 |
| Est. Completion | 2016-03-10 |
| Phase | Phase 3 |
What the finished NCT02274766 record still lists
NCT02274766 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 77 participants, a relatively small participant target, below the 115-participant average among 19 other Parkinsons Disease (PD) trials with a reported enrollment target (33% lower).
The record links to 3 conditions, with Parkinsons Disease (PD) appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT02274766 names 20 study sites across 13 states, led by Florida, California, Maryland.
Frequently Asked Questions
What is clinical trial NCT02274766 about?
NCT02274766 is a clinical study titled "Efficacy and Safety Study of ADS-5102 in PD Patients With Levodopa-Induced Dyskinesia". 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 NCT02274766?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 77 participants. The study started on 2014-10. Estimated completion is 2016-03-10.
What conditions does trial NCT02274766 study?
This clinical trial studies the following conditions: Parkinsons Disease (PD), Dyskinesia, Levodopa Induced Dyskinesia (LID).
What interventions are being tested in trial NCT02274766?
The interventions under investigation include: Placebo (OTHER), ADS-5102 (DRUG).
Who is sponsoring clinical trial NCT02274766?
This trial is sponsored by Adamas Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT02274766 being conducted?
This trial has 20 study locations across California, Florida, Georgia, Illinois, Kansas. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Parkinsons Disease (PD)
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT02274766's enrollment target sits among peer trials
77 10th of 19 higher than 10 of 19 other Parkinsons Disease (PD) trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Parkinsons Disease (PD) 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.
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