• Yuichi Inoue, Kenji Kuroda, Koichi Hirata, Naohisa Uchimura, Tatsuo Kagimura, and Tetsuo Shimizu.
• Japan Somnology Center, Neuropsychiatric Research Institute, Tokyo, Japan. inoue@somnology.com
• Neuropsychobiology. 2011 Jan 1;63(1):35-42.

AimsTo assess the safety and efficacy of pramipexole in Japanese patients with restless legs syndrome (RLS) and to investigate factors predictive of early treatment response.MethodsPatients with primary RLS and the International Restless Legs Syndrome Study Group rating scale (IRLS) total score of >15 were randomized to receive pramipexole 0.25, 0.5 or 0.75 mg/day for 6 weeks.ResultsA total of 154 patients were recruited. Following treatment, the mean adjusted change in IRLS score in the 0.25, 0.5 and 0.75 mg/day groups was -12.3, -12.5 and -11.8, respectively. The proportion of IRLS responders at week 2, when all patients were receiving pramipexole at a dose of 0.25 mg/day, was 34.0-37.7%. At 6 weeks, when the patients were on 0.25, 0.5 or 0.75 mg/day, IRLS responders defined as those having a ≥50% reduction in IRLS score accounted for 60.4, 58.5 and 49.1%, respectively. Older age above the median value (≥55 years) and low IRLS score at baseline (<21.5 points) were significantly associated with early response to low-dose pramipexole therapy. The type and frequency of adverse events were consistent with the known safety profile for dopamine agonists in RLS.ConclusionsPramipexole at 0.25-0.75 mg/day is efficacious, safe and well tolerated in Japanese patients with primary RLS.Copyright © 2010 S. Karger AG, Basel.

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