Trials / Completed
CompletedNCT00627003
A Study to Evaluate the Efficacy and Safety of Cabergoline Compared With Placebo for the Treatment of RLS
A Double-blind, Randomized, Placebo-controlled Multicenter Efficacy Study for the Treatment of Patients With Restless Legs Syndrome (RLS)
- Status
- Completed
- Phase
- Phase 3
- Study type
- Interventional
- Enrollment
- 43 (actual)
- Sponsor
- Pfizer · Industry
- Sex
- All
- Age
- 18 Years – 75 Years
- Healthy volunteers
- Not accepted
Summary
The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with placebo on periodic leg movements (PLMS) arousl index and sleep efficiency in patients with RLS. Also, additional objective and subjective sleep parameters and quality of life will be assessed.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | Cabergoline | Cabergoline oral tablets administered once daily in the evening: 0.5 mg daily on Days 1 to 3, 1.0 mg daily on Days 4 to 7, 1.5 mg daily on Days 8 to 10, and 2.0 mg daily on Days 11 to 14, followed by a stable dose for an additional 3 weeks |
| OTHER | Placebo | Placebo oral tablets administered daily for 5 weeks |
Timeline
- Start date
- 2002-11-01
- Completion
- 2003-05-01
- First posted
- 2008-02-29
- Last updated
- 2011-04-25
Source: ClinicalTrials.gov record NCT00627003. Inclusion in this directory is not an endorsement.