Article

A randomized controlled study of pergolide in patients with restless legs syndrome

Max Planck Institute of Psychiatry, Munich, Germany.
Neurology (Impact Factor: 8.3). 04/1999; 52(5):944-50. DOI: 10.1212/WNL.52.5.944
Source: PubMed

ABSTRACT Open clinical trials indicate that low doses of pergolide, a long-acting D1 and D2 dopamine agonist, lead to a reduction in the symptoms of restless legs syndrome (RLS) with subjective improvement in sleep quality.
To assess the therapeutic efficacy of pergolide in improving sleep and subjective measures of well-being in patients with idiopathic RLS using polysomnography and clinical ratings.
In a randomized, double-blind, placebo-controlled crossover design we enrolled 30 patients with idiopathic RLS according to the criteria of the International RLS Study Group. All patients were free of psychoactive drugs for at least 2 weeks before the study. Patients were monitored using polysomnography, clinical ratings, and sleep diaries at baseline and at the end of a 4-week pergolide or placebo treatment period. The initial dosage of 0.05 mg pergolide was increased to the best subjective improvement paralleled by 20 mg domperidone tid.
At a mean dosage of 0.51 mg pergolide as a single daily dose 2 hours before bedtime, there were fewer periodic leg movements per hour of time in bed (5.7 versus 54.9, p < 0.0001), and total sleep time was significantly longer (373 versus 261 minutes, p < 0.0001). Ratings of subjective sleep quality, quality of life, and severity of RLS were improved significantly without relevant adverse events.
Pergolide given as a single low-to-medium bedtime dose in combination with domperidone provides a well-tolerated and effective treatment of sensorimotor symptoms and sleep disturbances in patients with primary RLS.

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    • "The cause of RLS has yet to be identified, but a large body of evidence suggests that it is caused by impairment of the central dopaminergic system. Some of the evidence to support this idea includes that the fact that RLS symptoms improve after treatment with dopamine-mimetic agents and the results of recent neuroimaging studies (Montplaisir et al., 1999; Ruottinen et al., 2000; Turjanski et al., 1999; Wetter et al., 1999). RLS is also thought to occur more frequently in patients who take antipsychotics that block dopamine receptors. "
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