Trials / Completed
CompletedNCT00991276
Polysomnography Study Of Pregabalin And Pramipexole Versus Placebo In Patients With Restless Legs Syndrome And Associated Sleep Disturbance
A Randomized, Double-Blind, Placebo-Controlled, 3-Way Crossover, Multicenter Polysomnography Study Of Pregabalin And Pramipexole In Adults With Restless Legs Syndrome
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 85 (actual)
- Sponsor
- Pfizer's Upjohn has merged with Mylan to form Viatris Inc. · Industry
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to assess the efficacy and safety of pregabalin and pramipexole versus placebo in the treatment of restless legs syndrome and associated sleep disturbance.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | pregabalin | capsules; 300 mg once-per-day; 4 weeks of treatment |
| DRUG | placebo | capsules; 0 mg once-per-day; 4 weeks of treatment |
| DRUG | pramipexole | capsules; 0.5 mg once-per-day; 4 weeks of treatment |
Timeline
- Start date
- 2009-12-01
- Primary completion
- 2011-06-01
- Completion
- 2011-06-01
- First posted
- 2009-10-07
- Last updated
- 2021-02-15
- Results posted
- 2012-10-08
Locations
41 sites across 1 country: United States
Source: ClinicalTrials.gov record NCT00991276. Inclusion in this directory is not an endorsement.