12-Week Efficacy And Safety Of Pregabalin In Treating Restless Legs Syndrome (RLS) Subjects

Study Overview
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Brief Summary
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The purpose of this study is to assess efficacy and safety of pregabalin in treating moderate to severe Restless Legs Syndrome in comparison to placebo.

Official Title
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Randomized Double-Blind, 12-Week Study Of Pregabalin In Subjects With Restless Legs Syndrome

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Drug: Placebo
* Drug: pregabalin
* Drug: pregabalin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Idiopathic Restless Legs Syndrome with the presence of all four clinical manifestations of RLS: RLS symptoms occur predominantly in the evening RLS history at least 6 months International Restless Legs Study Group Rating Scale (IRLS) greater than or equal to 15 at the beginning and the end of placebo run-in Have greater than or equal to 15 nights with RLS symptoms in the month prior to screening Exclusion Criteria: Any secondary RLS Current augmentation due to RLS treatment Placebo responders identified during the placebo run-in

Ages Eligible for Study
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Minimum Age: 18 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 |
| --- | --- |
| Placebo Comparator: Placebo<br> | Drug: Placebo<br>* Placebo, orally administered once a day, 1-3 hours before bedtime for 12 weeks<br>|
| Experimental: Pregabalin 150 mg/day<br> | Drug: pregabalin<br>* pregabalin 150 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks<br>* Other names: Lyrica;|
| Experimental: Pregabalin 300 mg/day<br> | Drug: pregabalin<br>* pregabalin 300 mg, orally administered once a day, 1- 3 hours before the bedtime for 12 weeks<br>* Other names: Lyrica;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes from baseline in RLS symptom severity using the International Restless Leg Group Rating Scale (IRLS) total score for efficacy assessment |  | up to 12 weeks | 
| The proportion of subjects responding to treatment using the Clinical Global Impression - Improvement (CGI-I) scale for efficacy assessment |  | up to 12 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Subjective Sleep Questionnaire (SSQ - Subjective WASO) |  | up to 12 weeks | 
| RLS Next Day Impact (RLS-NDI) |  | up to 12 weeks | 
| Limb pain rating using a numerical rating scale (Limb Pain - NRS) |  | up to 12 weeks | 
| Clinical Global Impressions - Severity (CGI-S) |  | up to 12 weeks | 
| Medical Outcomes Study - Sleep Scale (MOS - SS) |  | up to 12 weeks | 
| Impact on Life (IRLS symptom impact sub-score) |  | up to 12 weeks | 
| RLS-Quality of Life Scale (RLS-QoL) |  | up to 12 weeks | 
| Medical Outcomes Study - Short Form 36 (SF-36) |  | up to 12 weeks | 
| Work Productivity and Activity Impairment - Specific Health Problem (WPAI-SHP) |  | up to 12 weeks | 
| Profile of Mood States (POMS) |  | up to 12 weeks | 
| Adverse events from spontaneous reports will be monitored throughout the trial and summarized by treatment group |  | up to 12 weeks | 
| Sheehan Suicidality Tracking Scale (S-STS) will be utilized to assess the risk of suicide |  | up to 12 weeks | 
| Changes in RLS symptoms following the discontinuation of study drug at the end of treatment will be evaluated by collection of the IRLS scores at the end of the drug taper period at Week 13 |  | week 13 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RLS