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Published online before print August 23, 2006, doi:10.1212/01.wnl.0000231513.23919.a1)
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 Volume 67, Number 6, September 26, 2006
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Received November 28, 2005
Accepted May 11, 2006

Efficacy and safety of pramipexole in restless legs syndrome

J. W. Winkelman MD, PhD*, K. D. Sethi MD, C. A. Kushida MD, PhD, P. M. Becker MD, J. Koester PhD, J. J. Cappola MD, PhD, and J. Reess MD

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.


* To whom correspondence should be addressed. E-mail: jwwinkelman{at}partners.org.

Abstract-- 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.




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Correspondence:

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Efficacy and safety of pramipexole in restless legs syndrome
Stefan P. Kruszewski, et al.
Neurology Online, 4 Dec 2006 [Full text]
Reply from the Authors
John W Winkelman, et al.
Neurology Online, 4 Dec 2006 [Full text]

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