Study shows MIRAPEX(R) (pramipexole) relieves patients with restless legs syndrome

Apr 28 2004

Results from a large-scale, randomized, double-blind study show MIRAPEX(R) (pramipexole) provides rapid relief in patients with restless legs syndrome (RLS).

The results of the study were presented this week at the American Academy of Neurology (AAN) meeting in San Francisco, CA. RLS refers to "unpleasant, deep discomfort, including paresthesias, inside the calves when sitting or lying down, especially just before sleep, producing an irresistible urge to move the legs."

In an analysis of 109 patients randomized to either placebo (n=22) or MIRAPEX (pramipexole) at a daily dose of 0.125 mg (n=21), 0.25 mg (n=22), 0.5 mg (n=22), or 0.75 (n=22), MIRAPEX (pramipexole) showed efficacy over the dose range of 0.125 mg/day to 0.75 mg/day within 3 weeks of therapy.

The primary endpoint of the study was the reduction in periodic limb movements during time in bed index (PLMI). Safety and tolerability of MIRAPEX (pramipexole) were favorable in all dose groups tested. "These findings are most valuable in understanding which drugs are effective in treating RLS, a condition that up to 10% of the general population experiences," said Dr. Markku Partinen, presenting author of the study results. "In this study, pramipexole demonstrates clearly that it is a promising new therapy for the treatment of restless legs syndrome."

No medication is currently approved by the U.S. Food & Drug Administration for restless legs syndrome. MIRAPEX (pramipexole) is indicated for the treatment of the signs and symptoms of Parkinson's disease.

The most commonly reported adverse events in clinical trials of early and late Parkinson's disease were dizziness, dyskinesia, extrapyramidal syndrome, hallucinations, headache, insomnia, somnolence, and nausea. Boehringer Ingelheim and Pfizer co-promote MIRAPEX (pramipexole) for Parkinson's disease in the US.