"Crossover" Drug Effective for Restless Legs Syndrome

EMBARGOED FOR RELEASE UNTIL 4 P.M. ET, MONDAY, NOVEMBER 25, 2002

An anticonvulsant drug typically used to control seizures and neuropathic pain may reduce symptoms among those who suffer from restless legs syndrome (RLS), a movement disorder that affects up to 10 percent of the population. A study published in the November 26 issue of Neurology, journal of the American Academy of Neurology, concludes, "Gabapentin may be a potent agent for treatment of even severe RLS, without the disadvantages of long-term complications of previously favored treatments," according to study author Diego Garcia-Borreguero, MD, of the Fundacion Jimenez Diaz in Madrid, Spain.

RLS is characterized by: an urge to move the legs, generally accompanied by unpleasant sensations; an increase of symptoms during rest and a partial, temporary relief of symptoms through activity; and worsening of symptoms in the evening or at night. Symptoms tend to progress with age. RLS is usually treated with dopaminergic drugs, such as those used with Parkinson's disease patients. However, the side effects and likelihood of long-term complications have driven the search for RLS treatment options.

Researchers performed a double-blind study of the effectiveness of gabapentin with 24 patients with RLS, eight men and 16 women. None of the patients had been treated previously with either gabapentin or dopaminergic medications, and any other medications were discontinued at least two weeks before the study began. Patients were randomized and assigned to receive either gabapentin or placebo in the first of two six-week intervals, with a one-week "washout period" between alternating treatments. Physical and neurological examinations were performed at baseline, at the first visit (neurological examination only), and at the end of each treatment period. Patients also completed hourly symptom severity ratings.

Using sleep studies as well as an RLS severity rating scale, a sleep questionnaire, and patients' own perception of clinical symptom change, researchers found treatment with gabapentin improved (reduced) RLS symptoms in the study group. Sleep studies also showed a marked reduction in leg movements, as well as an overall improvement of total sleep time and sleep quality during treatment with gabapentin. "Our study shows dramatic therapeutic effects of gabapentin in RLS under controlled conditions," concludes Garcia-Borreguero. "Additional long-term studies are warranted to confirm our outcomes and examine gabapentin tolerance during chronic treatment."

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