Efficacy and Safety of Pramipexole Compared to Placebo in the Treatment of Restless Legs Syndrome (RLS)

Study Overview
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Brief Summary
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A 12 week clinical trial was conducted in the United States in order to compare pramipexole (Mirapex®) versus placebo for the ability to reduce the symptoms of restless legs syndrome in adult subjects.

Official Title
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A Randomized, Double-blind, Placebo-controlled, Parallel Group Clinical Trial Comparing Fixed Doses of 0.25 mg, 0.50 mg and 0.75 mg Pramipexole (Mirapex®) Administered Orally to Investigate the Safety and Efficacy in Patients With Idiopathic Restless Legs Syndrome for 12 Weeks

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Drug: Pramipexole


Participation Criteria
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Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Intervention/Treatment |
| --- |
|Drug: Pramipexole|nan|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline in the total score of RLSRS (Restless Legs Syndrome rating scale for severity) of the IRLSSG (International Restless Legs Syndrome Study Group) |  | week 12 | 
| CGI-I (CGI-Improvement) |  | week 12 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RLSRS response (≥50% reduction from baseline in RLSRS) |  | at week 4, 6 and 12 | 
| CGI-I responder analysis |  | at week 4, 6 and 12 | 
| Change from baseline in CGI-Severity |  | at week 4, 6 and 12 | 
| CGI-therapeutic effect |  | at week 4, 6 and 12 | 
| CGI-Side effects |  | at week 4, 6 and 12 | 
| Patient Global Impression (PGI) |  | at week 1-4, 6 and 12 | 
| Visual analogue scales to assess RLS severity before sleep onset, during night and during day, and satisfaction with sleep |  | at week 4, 6 and 12 | 
| Change from baseline in Epworth sleepiness scale (ESS) |  | at week 4, 6 and 12 | 
| Change from baseline in RLS-QOL (Johns Hopkins Restless Legs Syndrome Quality of Life questionnaire) |  | at week 6 and 12 | 
| Change from baseline in Augmentation Severity Rating Scale of IRLSSG |  | at week 6 and 12 | 
| Change in systolic and diastolic blood pressure (after 5 minutes supine and subsequently after 1 minute standing) |  | week 12 | 
| Change in pulse rate (palpation after 5 minute supine and subsequent after 1 minute standing) |  | week 12 | 
| Change in routine laboratory tests |  | week 12 | 
| Change in Physical examinations including eye examinations with ophthalmoscopic retinal eye examinations and a full skin dermatologic examination |  | week 12 | 
| Change in Electrocardiogram |  | 12 weeks | 
| Incidence of Adverse evens (including withdrawal symptoms and rebound symptoms) |  | up to 93 days | 
| Concomitant medication reporting |  | 12 weeks | 
| Early withdrawal phenomena |  | 12 weeks | 
| Assessment of sudden onset of sleep (SOOS) |  | up to 93 days |