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NCT02471222 · ClinicalTrials.gov registry record · Phase 2
Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment
A Phase 2 study, sponsored by Adamas Pharmaceuticals.
- Completed
- Registry status
- Phase 2
- Development phase
- 60
- Enrollment target
NCT02471222 is a Phase 2 study that has completed, run by Adamas Pharmaceuticals. The registered enrollment target is 60 participants.
The verdict
NCT02471222, a Phase 2 study, has completed, sponsored by Adamas Pharmaceuticals.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 60 participants
- Enrollment target
Study Summary
This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once daily at bedtime for the treatment of walking impairment in MS. ADS-5102 is designed to be administered once daily at bed time, ADS-5102 achieves higher plasma amantadine concentrations in the early morning, sustained throughout the afternoon, and lower concentrations in the evening when patients are sleeping. ADS-5102 is designed to deliver its primary treatment effect during the day, and potentially reduce the adverse events of immediate-release amantadine when the patient is asleep.
Interventions
- OTHER Placebo
- DRUG ADS-5102
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 60 participants |
| Start Date | 2015-05 |
| Est. Completion | 2016-06 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT02471222
The ClinicalTrials.gov registry entry for NCT02471222 describes a study currently listed as completed, categorized as Phase 2. The registered enrollment target is 60 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.
NCT02471222 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT02471222 about?
NCT02471222 is a clinical study titled "Safety and Efficacy of ADS-5102 in Patients With Multiple Sclerosis and Walking Impairment". This is a multi-center, randomized, double-blind, placebo-controlled, 2-arm, parallel group study of ADS-5102 extended release (ER) capsules, an investigational formulation of amantadine, dosed once daily at bedtime for the treatment of walking impairment in MS. ADS-5102 is designed to be administer...
What is the current status of trial NCT02471222?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 60 participants. The study started on 2015-05. Estimated completion is 2016-06.
What interventions are being tested in trial NCT02471222?
The interventions under investigation include: Placebo (OTHER), ADS-5102 (DRUG).
Who is sponsoring clinical trial NCT02471222?
This trial is sponsored by Adamas Pharmaceuticals, which has 10 total clinical trials registered on ClinicalTrials.gov.
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