Phase IV Trial With Pramipexole to Evaluate Safety and Efficacy in Patients With RLS Associated With Mood Disturbances
NCT00356096 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 404
Last updated 2012-05-21
Summary
The primary objective of this study is to determine the efficacy of pramipexole 0.125 mg to 0.75 mg daily versus placebo on RLS symptoms and on associated mood disturbances and depressive symptoms, after 12 weeks of treatment
Conditions
- Restless Legs Syndrome
- Depression
Interventions
- DRUG
-
pramipexole
Sponsors & Collaborators
- lead INDUSTRY
Principal Investigators
-
Boehringer Ingelheim · Boehringer Ingelheim
Study Design
- Purpose
- TREATMENT
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2006-07-31
- Primary Completion
- 2007-06-30
Countries
- Finland
- France
- Germany
- Ireland
- Italy
- South Korea
- Spain
- Sweden
- United Kingdom
Study Locations
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