BOEHRINGER INGELHEIM'S MIRAPEX STUDIED IN TREATING RLS

According to a study published in the journal Neurology, Boehringer Ingelheim's Mirapex (pramipexole dihydrochloride) significantly improved symptoms in patients with moderate to severe restless legs syndrome (RLS) versus placebo, as measured by the study's primary efficacy endpoints. The drug is currently approved for the treatment of idiopathic Parkinson's disease.

Significant treatment effects were also apparent for the study's secondary efficacy endpoints, where pramipexole improved ratings of daytime and nighttime symptom severity, as well as sleep satisfaction and quality of life.

The trial was a 12-week, multicenter, double-blind, randomized, placebo-controlled study of fixed daily doses of pramipexole (0.25 mg, 0.50 mg and 0.75 mg) in patients with moderate to severe RLS. Data from 339 patients were analyzed to evaluate the effect of pramipexole treatment on efficacy and safety. The mean age of patients was 51.4 years and the mean duration of RLS symptoms was 5.1 years. All patients were instructed to take pramipexole two to three hours before bedtime.

After 12 weeks, the mean International RLS Study Group Rating Scale change in total score from baseline was greater in patients receiving pramipexole than in those patients receiving placebo. The overall frequency of adverse events was similar in all treatment groups, and most side effects were judged to be of minor severity. The frequency of adverse events was higher in the pramipexole groups. The most commonly reported adverse events included nausea, headache, insomnia and somnolence.