A Study to Determine the Efficacy and Safety of Cabergoline for the Treatment of Patients With RLS

Study Overview
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Brief Summary
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The purpose of this study is to evaluate the efficacy and safety of cabergoline compared with levodopa in the treatment of patients with RLS.

Official Title
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A Double-Blind, Randomized, Active-Controlled Multicenter Efficacy Trial for the Treatment of Patients With Restless Legs Syndrome (RLS)

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Drug: cabergoline
* Drug: levodopa


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Diagnosis of idiopathic RLS and had all 4 clinical manifestations of RLS Moderate to severe symptoms of RLS as indicated by an IRLSSG-RS total score greater than or equal to 10 and a severity at night score of greater than or equal to 4 on an 11-point RLS-6 rating scale No previous treatment for RLS or dissatisfaction with their current therapy Exclusion Criteria: Not available

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 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

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br> | Drug: cabergoline<br>* Cabergoline oral tablets: 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 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 3 mg daily if patient experienced insufficient efficacy without impairing adverse events<br>|
| Experimental: 2<br> | Drug: levodopa<br>* Levodopa oral capsules: 25 mg twice daily on Days 1 to 3, 50 mg twice daily on Days 4 to 7, 100 mg twice daily on Days 8 to 14 and then administered as a stable dose for a further 4 weeks; at Week 6, dose could be increased to 150 mg twice daily if patient experienced insufficient efficacy without impairing adverse events<br>|

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 the International RLS Study Group Rating Scale (IRLSSG-RS) |  | Week 6 | 
| Time to dropout due to a necessary change in RLS therapy because of augmentation or loss of efficacy (e.g., dose increment of study drug, switch to another therapy, or start of a drug-free period) |  |  | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| RLS quality-of-life questionnaire |  | Weeks 6 and 30 | 
| Clinical Global Impression |  | Weeks 6 and 30 | 
| Patient Global Impression |  | Weeks 6 and 30 | 
| Sleep questionnaire form A |  | Weeks 6 and 30 | 
| IRLSSG-RS |  | Week 30 | 
| Safety evaluation including adverse events, clinically relevant changes in laboratory data, physical exam findings, and abnormalities observed in electrocardiogram |  | Weeks 2, 6, and 8 during Period 1 and every 4 weeks during Period 2 | 
| Rating of severity of RLS at night (RLS-6 scale) |  | Weeks 6 and 30 | 
| Rating of severity of RLS before bedtime (RLS-6 scale) |  | Weeks 6 and 30 | 
| Rating of severity of RLS at day when at rest and during activities, severity of daytime sleepiness (RLS-6 scales) |  | Weeks 6 and 30 | 
| Global rating of quality of sleep (RLS-6 scale) |  | Weeks 6 and 30 |