Pramipexole (BI-Sifrol®) Orally Once Daily for 6 Weeks in Patients With Primary Restless Legs Syndrome

Summary

The objective of this trial is to investigate the efficacy and safety of pramipexole (0.125-0.75 mg) orally once daily as compared with placebo for 6 weeks in patients with primary restless legs syndrome (RLS) and to investigate the reliability of the Japanese version of the RLS rating scale by the International Restless Legs Syndrome Study Group (IRLSSG) as a sub-study.

Timeline

Start

2004-08

Primary completion

2005-12

Completion

—

Publications

• Inoue Y, Oka Y, Kagimura T, Kuroda K, Hirata K. Reliability, validity, and responsiveness of the Japanese version of International Restless Legs Syndrome Study Group rating scale for restless legs syndrome in a clinical trial setting. Psychiatry Clin Neurosci. 2013 Sep;67(6):412-9. doi: 10.1111/pcn.12074. Epub 2013 Aug 5.

Drugs

Indications