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This Article Figures Only Full Text Full Text (PDF) CME: Take the course for this article: Volume 67, Number 6, September 26, 2006 All Versions of this Article: 01.wnl.0000231513.23919.a1v1 67/6/1034    most recent Correspondence: Submit a response Correspondence: View responses Alert me when this article is cited Alert me when Correspondence are posted Alert me if a correction is posted Citation Map Services Email this article to a friend Similar articles in this journal Similar articles in PubMed Alert me to new issues of the journal Download to citation manager Citing Articles Citing Articles via HighWire Citing Articles via Google Scholar Google Scholar Articles by Winkelman, J. W. Articles by Reess, J. Search for Related Content PubMed PubMed Citation Articles by Winkelman, J. W. Articles by Reess, J. Related Collections All Clinical trials Clinical trials Randomized controlled (CONSORT agreement) Restless legs syndrome

Efficacy and safety of pramipexole in restless legs syndrome

From the Division of Sleep Medicine (J.W.W.), Brigham and Women's Hospital, Harvard Medical School, Boston, MA; Department of Neurology (K.D.S.), Medical College of Georgia, Augusta, GA; Department of Psychiatry and Behavioral Sciences (C.A.K.), Stanford University School of Medicine, Stanford, CA; Department of Psychiatry (P.M.B.), The University of Texas Southwestern Medical Center at Dallas, Dallas, TX; Medical Division (J.K.), Boehringer Ingelheim International GmbH, Ingelheim, Germany; Clinical Operations (J.J.C.), Boehringer Ingelheim Pharmaceuticals, Inc., Ridgefield, CT; Clinical Research CNS (J.R.), Boehringer Ingelheim Pharma GmbH & Co. KG, Biberach, Germany.

Address correspondence and reprint requests to Dr. John W. Winkelman, Brigham and Women's Hospital Sleep Health Center, 1505 Commonwealth Avenue, Brighton, MA 02135; e-mail: jwwinkelman{at}partners.org.

Objective: To evaluate the efficacy and safety of pramipexole in patients with moderate to severe restless legs syndrome (RLS)

Methods: The authors conducted a 12-week, double-blind, randomized, placebo-controlled trial of fixed doses of pramipexole (0.25, 0.50, and 0.75 mg/day). Patients (N = 344) were up-titrated to their randomized dose over 3 weeks. The primary efficacy endpoints were patient ratings of symptom severity on the International RLS Study Group Rating Scale (IRLS) and clinician ratings of improvement on the Clinical Global Impressions-Improvement (CGI-I) scale. Secondary efficacy endpoints included visual analogue ratings of sleep and quality of life (QOL)

Results: By both primary measures, pramipexole was superior to placebo. For IRLS, the adjusted mean (SE) change from baseline to week 12 was –9.3 (1.0) for placebo, –12.8 (1.0) for 0.25 mg/day, –13.8 (1.0) for 0.50 mg/day, and –14.0 (1.0) for 0.75 mg/day (all p < 0.01). Similarly, pramipexole increased the percentage of patients with a CGI-I rating of "very much improved" or "much improved" at the end of the trial (51.2% for placebo and 74.7%, 67.9%, and 72.9% for pramipexole; all p < 0.05). Pramipexole significantly improved ratings of symptom severity, day and night, and also ratings of sleep satisfaction and QOL. Pramipexole was well tolerated: The most frequent adverse events with higher occurrence in the pramipexole group were nausea (19.0% vs 4.7%) and somnolence (10.1% vs 4.7%)

Conclusion: As rated by patients and by clinicians, pramipexole was efficacious and safe in reducing the symptoms of restless legs syndrome.

This article was previously published in electronic format as an Expedited E-Pub on August 23, 2006, at www.neurology.org.

Supported by a grant from Boehringer Ingelheim Pharmaceuticals, Inc.

Disclosure: P.M. Becker has received grants from Boehringer Ingelheim Pharmaceuticals, Inc., not in excess of US$10,000 per year, for other research or activities not reported in this article. C.A. Kushida has received grants from Boehringer Ingelheim Pharmaceuticals, Inc., not in excess of US$10,000 per year, for other research or activities not reported in this article. K.D. Sethi has received grants for other research or activities not reported in this article and has received honoraria during the course of this study from Boehringer Ingelheim Pharmaceuticals, Inc. in excess of US$10,000 per year. J.W. Winkelman has received grants for other research or activities not reported in this article and has received honoraria during the course of this study from Boehringer Ingelheim Pharmaceuticals, Inc. in excess of US$10,000 per year. All other authors listed report no conflicts of interest.

Received November 28, 2005. Accepted in final form May 11, 2006.

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