Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

Study Overview
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Brief Summary
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This study will evaluate the safety and efficacy of Pregabalin (Lyrica) in treating patients with Restless Legs Syndrome (RLS) in a double-blind, placebo-controlled trial.

Official Title
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Pregabalin (Lyrica) for the Treatment of Restless Legs Syndrome

Conditions
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Restless Legs Syndrome

Intervention / Treatment
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* Drug: Pregabalin (Lyrica)
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Outpatients with RLS diagnosed by a movement disorder specialist/ Sleep specialist . Patients must report some degree of pain which occurs on a regular basis. Age 18 years to 80 years. Women of child-bearing potential must use a reliable method of contraception and must provide a negative pregnancy test at entry into the study. Stable doses of all medications for 30 days prior to study entry and for the duration of the study. Willing and able to provide informed consent. Willing to comply with protocol. - Exclusion Criteria: Any illness that in the investigator's opinion preclude participation in this study. Pregnancy or lactation. Concurrent participation in another clinical study. Current treatment with a dopamine agonist (unless stopped at least 2 weeks prior to baseline). Dementia or other psychiatric illness that prevents the patient from giving informed consent (Mini Mental Status Exam score less than 24). Legal incapacity or limited legal capacity. Presence of severe renal disease BUN 50% greater than normal, Patients must have evidence from their PCP or Urologists of normal PSA and urodynamic tests within the last 12 month. Normal BUN levels should be within a range of 5 to 20 mg/ d L and creatinine between .7 and 1.4 mg/ d L. Labs will be requested from PCP. Presence of major hepatic impairment (Cirrhosis, Viral Hepatitis, Nonalcoholic Steatohepatitis, Wilson's disease, or Hemochromatosis). LFT must show non-clinically significant results (Albumin range 3.0-6.0; Alkaline phosphatase range 40-150; ALT range 0-55; AST range 5-34). Presence of severe daytime sleepiness. Present complaints of somnolence, dizziness, blurred vision, bleeding tendencies, cardiac abnormalities. Patients taking dopamine agonists for any condition other than RLS. -

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 1<br>Pregabalin (Lyrica) | Drug: Pregabalin (Lyrica)<br>* 50 - 150 mg po qhs for 2 months<br>|
| Placebo Comparator: 2<br>Placebo | Drug: Pregabalin (Lyrica)<br>* 50 - 150 mg po qhs for 2 months<br>Drug: Placebo<br>* 50 - 150 mg po qhs for 2 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| International RLS Study Group Severity Scale (IRLS) |  | 2 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Clinical Global Impression (CGI) |  | 2 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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RLS, Restless legs syndrome, Pregabalin, Lyrica