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Efficacy of cabergoline in restless legs syndrome: a placebo-controlled study with polysomnography (CATOR).
Neurology. 2006 Sep 26; 67(6):1040-6.Neur

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.

Authors+Show Affiliations

Department of Neurology, Center of Nervous Diseases, Philipps-University Marburg, Rudolf-Bultmann-Str. 8, D-35033 Marburg, Germany. oertelw@med.uni-marburg.deNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

Comparative Study
Journal Article
Multicenter Study
Randomized Controlled Trial
Research Support, Non-U.S. Gov't

Language

eng

PubMed ID

16931508

Citation

Oertel, W H., et al. "Efficacy of Cabergoline in Restless Legs Syndrome: a Placebo-controlled Study With Polysomnography (CATOR)." Neurology, vol. 67, no. 6, 2006, pp. 1040-6.
Oertel WH, Benes H, Bodenschatz R, et al. Efficacy of cabergoline in restless legs syndrome: a placebo-controlled study with polysomnography (CATOR). Neurology. 2006;67(6):1040-6.
Oertel, W. H., Benes, H., Bodenschatz, R., Peglau, I., Warmuth, R., Happe, S., Geisler, P., Cassel, W., Leroux, M., Kohnen, R., & Stiasny-Kolster, K. (2006). Efficacy of cabergoline in restless legs syndrome: a placebo-controlled study with polysomnography (CATOR). Neurology, 67(6), 1040-6.
Oertel WH, et al. Efficacy of Cabergoline in Restless Legs Syndrome: a Placebo-controlled Study With Polysomnography (CATOR). Neurology. 2006 Sep 26;67(6):1040-6. PubMed PMID: 16931508.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Efficacy of cabergoline in restless legs syndrome: a placebo-controlled study with polysomnography (CATOR). AU - Oertel,W H, AU - Benes,H, AU - Bodenschatz,R, AU - Peglau,I, AU - Warmuth,R, AU - Happe,S, AU - Geisler,P, AU - Cassel,W, AU - Leroux,M, AU - Kohnen,R, AU - Stiasny-Kolster,K, Y1 - 2006/08/23/ PY - 2006/8/26/pubmed PY - 2006/10/13/medline PY - 2006/8/26/entrez SP - 1040 EP - 6 JF - Neurology JO - Neurology VL - 67 IS - 6 N2 - 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. SN - 1526-632X UR - https://www.unboundmedicine.com/medline/citation/16931508/Efficacy_of_cabergoline_in_restless_legs_syndrome:_a_placebo_controlled_study_with_polysomnography__CATOR__ L2 - http://www.neurology.org/cgi/pmidlookup?view=long&pmid=16931508 DB - PRIME DP - Unbound Medicine ER -