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


OBJECTIVE
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.


METHODS
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.


RESULTS
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.


CONCLUSIONS
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.
Wetter
T C
TC
Max Planck Institute of Psychiatry, Munich, Germany.
Stiasny
K
K
Winkelmann
J
J
Buhlinger
A
A
Brandenburg
U
U
Penzel
T
T
Medori
R
R
Rubin
M
M
Oertel
W H
WH
Trenkwalder
C
C
D000328:Adult; D000368:Aged; D004311:Double-Blind Method; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D010479:Pergolide / Q000009:adverse effects / Q000627:therapeutic use*; D017286:Polysomnography; D011788:Quality of Life; D012148:Restless Legs Syndrome / Q000188:drug therapy*; D011795:Surveys and Questionnaires; D013577:Syndrome; D013997:Time Factors
D010479:Pergolide