Efficacy of cabergoline in restless legs syndrome: a placebo-controlled study with polysomnography (CATOR).
OBJECTIVE
To assess the efficacy and safety of the dopamine agonist cabergoline in the treatment of patients with idiopathic restless legs syndrome (CATOR study).


METHODS
Patients with moderate to severe restless legs syndrome (RLS) were randomly assigned to cabergoline (single evening dose: 2 mg) or placebo and treated for 5 weeks in a double-blind, multicenter polysomnography (PSG) trial. The primary efficacy measures were the periodic leg movements during sleep arousal index (PLMS-AI) and sleep efficiency. These and further PSG variables were monitored by centrally evaluated PSG. Severity of RLS was assessed using the International RLS Study Group Severity Scale (IRLS), the RLS-6 scales, the Sleep Questionnaire Form A (SF-A; quality of sleep), and the Quality of Life for RLS questionnaire.


RESULTS
Forty-three patients were treated and 40 patients were evaluated with PSG (age 56 +/- 10 years, 73% women). Cabergoline was superior to placebo in terms of the PLMS-AI (-17.7 +/- 16.4 vs -4.5 +/- 20.0 placebo; p = 0.0024), sleep efficiency (+6.2 +/- 13.9% vs +3.3 +/- 11.7%; p = 0.0443), PLMS index (p = 0.0014), PLM index (p = 0.0012), and total sleep time (p = 0.0443). Improvements in IRLS total score (-23.7 +/- 11.2 vs -7.9 +/- 11.0 placebo; p = 0.0002), RLS-6 severity scales during the night (p = 0.0010) and during the day (p = 0.0018), Clinical Global Impressions severity item (p = 0.0003), sleep quality (p = 0.0180), SF-A sleep quality (p = 0.0371), and QoL-RLS (p = 0.0247) were larger in patients treated with cabergoline compared with the placebo group. Adverse events were only mild and well-known side effects of dopamine agonists.


CONCLUSIONS
Single-evening cabergoline is an efficacious and well-tolerated short-term therapy for sensorimotor symptoms of restless legs syndrome and associated sleep disturbances.
Oertel
W H
WH
Department of Neurology, Center of Nervous Diseases, Philipps-University Marburg, Rudolf-Bultmann-Str. 8, D-35033 Marburg, Germany. oertelw@med.uni-marburg.de
Benes
H
H
Bodenschatz
R
R
Peglau
I
I
Warmuth
R
R
Happe
S
S
Geisler
P
P
Cassel
W
W
Leroux
M
M
Kohnen
R
R
Stiasny-Kolster
K
K
D000293:Adolescent; D000328:Adult; D000368:Aged; D000077465:Cabergoline; D016022:Case-Control Studies; D018491:Dopamine Agonists / Q000627:therapeutic use*; D004311:Double-Blind Method; D004334:Drug Administration Schedule; D004873:Ergolines / Q000627:therapeutic use*; D005260:Female; D006801:Humans; D008297:Male; D008875:Middle Aged; D011594:Psychometrics; D012148:Restless Legs Syndrome / Q000188:drug therapy* / Q000503:physiopathology*; D012720:Severity of Illness Index; D018709:Statistics, Nonparametric
D018491:Dopamine Agonists; D004873:Ergolines; D000077465:Cabergoline