Pramipexole for Chinese people with primary restless legs syndrome: a 12-week multicenter, randomized, double-blind study.

BACKGROUND

Restless legs syndrome (RLS) often responds to agents that enhance dopamine neurotransmission. The present 12-week study aimed to evaluate the efficacy and adverse events of pramipexole (PPX) for the treatment of adult, Chinese people with primary RLS.

METHODS

A total of 204 Chinese people with RLS were randomly assigned to receive either the placebo or PPX (flexibly titrated from 0.25 mg to 0.75 mg), 2 h to 3 h before bedtime for 12 weeks. The primary measuring outcomes were the International RLS Study Group Rating Scale (IRLS) and the Clinical Global Impressions-Improvement (CGI-I) scale. The secondary outcome was adverse events.

RESULTS

One hundred and ninety participants completed the study. At 12 weeks, the adjusted mean (SE) change from baseline was greater for PPX (vs placebo) for the IRLS score (-13.2 ± 0.7 vs -9.4 ± 0.6; p <0.01), and (-12.1 ± 0.6 vs -8.3 ± 0.6; p <0.01) at the end of one month follow-up after treatment. The CGI-I rating of "very much improved" or "much improved" in the percentage of participants (61.8% vs 34.3%; p <0.01), and (51.0% vs 26.5%; p <0.01) after week 12, and one month follow-up of treatment, respectively. The proportion of adverse events was 60.8% in the PPX group and 45.1% in the placebo group. No deaths related to PPX treatment were recorded.

CONCLUSIONS

In summary, the present study showed that PPX is efficacious and well tolerated in Chinese people with primary RLS.