Oertel, W. H. and Benes, H. and Bodenschatz, R. and Peglau, I. and Warmuth, R. and Happe, S. and Geisler, P. and Cassel, W. and Leroux, M. and Kohnen, R. and Stiasny-Kolster, K. (2006) Efficacy of cabergoline in restless legs syndrome - A placebo-controlled study with polysomnography (CATOR). NEUROLOGY, 67 (6). pp. 1040-1046. ISSN 0028-3878,
Full text not available from this repository. (Request a copy)Abstract
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. Conclusion: Single-evening cabergoline is an efficacious and well-tolerated short-term therapy for sensorimotor symptoms of restless legs syndrome and associated sleep disturbances.
| Item Type: | Article |
|---|---|
| Uncontrolled Keywords: | LIMB MOVEMENT-DISORDER; CLINICAL FOLLOW-UP; SR-L-DOPA; DOUBLE-BLIND; SYNDROME RLS; CROSSOVER TRIAL; PERGOLIDE; MULTICENTER; PRAMIPEXOLE; GABAPENTIN; |
| Subjects: | 600 Technology > 610 Medical sciences Medicine |
| Divisions: | Medicine > Lehrstuhl für Psychiatrie und Psychotherapie |
| Depositing User: | Dr. Gernot Deinzer |
| Date Deposited: | 27 Jan 2021 10:26 |
| Last Modified: | 27 Jan 2021 10:26 |
| URI: | https://pred.uni-regensburg.de/id/eprint/34010 |
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