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Pramipexole for RLS

Clinical bottom line

In a tiny trial of 10 patients with RLS, pramipexole exhibited apparent good efficacy, with some adverse events, mostly transient.


J Montplaisir et al. Restless legs syndrome improved by pramipexole: a double-blind randomized trial. Neurology 1999 52: 938-943.

J Montplaisir et al. Pramipexole in the treatment of restless legs syndrome: a follow-up study. European Journal of Neurology Suppl 2000 7 (Suppl 1): 27-31.

Clinical trial

The first trial had a randomised, double-blind, crossover design, comparing pramipexole 0.75 to 1.5 mg daily with placebo over two four-week treatments. There were 10 patients. Outcomes were sleep studies, including periodic limb movement, and questionnaires about symptoms.


Patients were aged 30-61 years (49 years on average). Pramipexole significantly improved some indices of RLS compared with placebo, but did not improve sleep latency, sleep efficiency, or number of awakenings. There was a large decrease in the number of periodic limb movements. Nine of 10 patients reported complete disappearance of RLS symptoms with pramipexole, and the other had a major improvement.

Nine patients reported various mild adverse events during the first week, with persistent nausea or daytime fatigue in two.

A follow study of seven patients for an average of 8 months showed no evidence of a decrease in therapeutic effect.


There is insufficient evidence on which to base any conclusions regarding pramipexole for RLS.