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Restless Leg Syndrome Symptoms Show Improvement With Pramipexole: Presented at AAN

By Claire Sowerbutt

SAN DIEGO, C.A. -- April 10, 2006 -- Data from 2 studies that evaluated pramipexole in patients with restless leg syndrome (RLS) show significant benefit in providing symptom relief and improving quality of life (QoL).

John W. Winkelman, MD, PhD, medical director, Sleep Health Center, Brigham and Women's Hospital, Boston, Massachusetts, United States, presented the data from 1 study here on April 4^th during the 58^th Annual Meeting of the American Academy of Neurology (AAN).

The double-blind, placebo-controlled, parallel-group study randomised patients to 3 daily doses of pramipexole (0.25 mg, 0.50 mg, 0.75 mg) or placebo.

Dr. Winkelman and colleagues enrolled 215 women and 129 men with a mean age of 51.4 years and a mean duration of RLS of 5.1 years. Efficacy and QoL, measured using the Johns Hopkins Restless Leg Syndrome Quality of Life Questionnaire, were assessed using data from 339 patients.

The adjusted mean changes from baseline for placebo and each dose of pramipexole on the International RLS rating scale (IRLS) were -9.3, -12.8, -13.8, and -14.0, respectively, (P =.0086, P =.0011, and P =.0005, respectively).

QoL measures showed 56% improvement in pramipexole treated patients.

In a second presentation, Claudia Trenkwalder, MD, professor of medicine, Göttingen University, Paracelsus-Elena Clinic, Kassel, Germany, discussed the findings of a multicentre, randomised, placebo-controlled, double-blind withdrawal trial of pramipexole.

In this study, the researchers observed sustained symptomatic improvement in 150 patients who received pramipexole for 6 months in an open-label run-in phase after which they were randomised to either placebo or continued pramipexole for a further 3 months. The mean patient age in this study was 59.6 years, 72% were female, and the mean duration of RLS symptoms was 5.6 years.

At the end of the randomised phase, physician and patient assessments showed that beneficial effects of pramipexole were maintained in 60.3% of patients in the active treatment arm and in 23.1% of placebo patients. These effects were highly significant using the Mantel-Haenszel test (P <.0001).

Worsening of symptoms was seen in 75.4% of placebo patients and in 16.7% of pramipexole patients.

"These studies provide evidence that supports efficacy and safety of pramipexole for restless leg syndrome across a range of symptoms which were sustained over time," Dr. Winkelman said.

Pramipexole is currently approved by the United States Food and Drug Administration (FDA) for the treatment of idiopathic Parkinson's disease either in combination with levodopa or as monotherapy. A supplemental new drug application has been filed with the FDA for pramipexole treatment of symptomatic RLS.

Adverse effects commonly associated with this agent include dizziness, dyskinesia, headache, extra pyramidal syndrome, nausea, somnolence, and insomnia.

The research was supported by Boehringer Ingelhiem.


[Presentation titles: Pramipexole Is Efficacious and Safe in Treating Patients With RLS. Abstract P02.020. Sustained Effects of Pramipexole on Clinician Ratings of Improvement in Patients With Restless Legs Syndrome (RLS). Abstract P02.017]

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