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Ropinirole in the treatment of patients with restless legs syndrome: a US-based randomized, double-blind, placebo-controlled clinical trial.
Mayo Clin Proc. 2006 Jan; 81(1):17-27.MC

Abstract

OBJECTIVE

To assess the efficacy, safety, and tolerability of the dopamine agonist ropinirole in the treatment of patients with moderate to severe primary restless legs syndrome (RLS).

PATIENTS AND METHODS

This multicenter, 12-week, double-blind, placebo-controlled, flexible-dose study enrolled US patients and was conducted between September 2003 and May 2004. Patients were randomized to ropinirole or placebo, 0.25-4.0 mg as needed and tolerated, once daily, 1 to 3 hours before bedtime. The primary end point was mean change from baseline to week 12 in International Restless Legs Scale (IRLS) total score. Key secondary efficacy measures included the Clinical Global Impression-Improvement scale.

RESULTS

A total of 381 patients were enrolled; 164 (87.7%) of 187 patients randomized to ropinirole and 167 (86.1%) of 194 randomized to placebo completed the study. Significant treatment differences favoring ropinirole, compared with placebo, were observed for change in IRLS total score at week 12 (adjusted mean treatment difference, -3.7; 95% confidence interval, -5.4 to -2.0; P < .001) and for all 3 key secondary end points: mean change from baseline in IRLS total score at week 1 and proportion of patients who were much/very much improved on the Clinical Global Impression Improvement scale at weeks 1 and 12. Ropinirole was associated with significantly greater Improvements in subjective measures of sleep disturbance, quantity, and adequacy; quality of life; and anxiety. Although treatment differences favoring ropinirole in daytime somnolence were observed, they were not statistically significant (P = .10). Ropinirole was generally well tolerated, with an adverse-event profile consistent with other dopamine agonists.

CONCLUSION

This study confirms that ropinirole improves RLS symptoms and subjective measures of sleep, quality of life, and anxiety and that it is generally well tolerated.

Authors+Show Affiliations

SleepMed of South Carolina, 1333 Taylor St, Columbia, SC 29201, USA. rbogan@sleepmed.mdNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info availableNo affiliation info available

Pub Type(s)

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

Language

eng

PubMed ID

16438474

Citation

Bogan, Richard K., et al. "Ropinirole in the Treatment of Patients With Restless Legs Syndrome: a US-based Randomized, Double-blind, Placebo-controlled Clinical Trial." Mayo Clinic Proceedings, vol. 81, no. 1, 2006, pp. 17-27.
Bogan RK, Fry JM, Schmidt MH, et al. Ropinirole in the treatment of patients with restless legs syndrome: a US-based randomized, double-blind, placebo-controlled clinical trial. Mayo Clin Proc. 2006;81(1):17-27.
Bogan, R. K., Fry, J. M., Schmidt, M. H., Carson, S. W., & Ritchie, S. Y. (2006). Ropinirole in the treatment of patients with restless legs syndrome: a US-based randomized, double-blind, placebo-controlled clinical trial. Mayo Clinic Proceedings, 81(1), 17-27.
Bogan RK, et al. Ropinirole in the Treatment of Patients With Restless Legs Syndrome: a US-based Randomized, Double-blind, Placebo-controlled Clinical Trial. Mayo Clin Proc. 2006;81(1):17-27. PubMed PMID: 16438474.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ropinirole in the treatment of patients with restless legs syndrome: a US-based randomized, double-blind, placebo-controlled clinical trial. AU - Bogan,Richard K, AU - Fry,June M, AU - Schmidt,Markus H, AU - Carson,Stanley W, AU - Ritchie,Sally Y, AU - ,, PY - 2006/1/28/pubmed PY - 2006/2/8/medline PY - 2006/1/28/entrez SP - 17 EP - 27 JF - Mayo Clinic proceedings JO - Mayo Clin. Proc. VL - 81 IS - 1 N2 - OBJECTIVE: To assess the efficacy, safety, and tolerability of the dopamine agonist ropinirole in the treatment of patients with moderate to severe primary restless legs syndrome (RLS). PATIENTS AND METHODS: This multicenter, 12-week, double-blind, placebo-controlled, flexible-dose study enrolled US patients and was conducted between September 2003 and May 2004. Patients were randomized to ropinirole or placebo, 0.25-4.0 mg as needed and tolerated, once daily, 1 to 3 hours before bedtime. The primary end point was mean change from baseline to week 12 in International Restless Legs Scale (IRLS) total score. Key secondary efficacy measures included the Clinical Global Impression-Improvement scale. RESULTS: A total of 381 patients were enrolled; 164 (87.7%) of 187 patients randomized to ropinirole and 167 (86.1%) of 194 randomized to placebo completed the study. Significant treatment differences favoring ropinirole, compared with placebo, were observed for change in IRLS total score at week 12 (adjusted mean treatment difference, -3.7; 95% confidence interval, -5.4 to -2.0; P < .001) and for all 3 key secondary end points: mean change from baseline in IRLS total score at week 1 and proportion of patients who were much/very much improved on the Clinical Global Impression Improvement scale at weeks 1 and 12. Ropinirole was associated with significantly greater Improvements in subjective measures of sleep disturbance, quantity, and adequacy; quality of life; and anxiety. Although treatment differences favoring ropinirole in daytime somnolence were observed, they were not statistically significant (P = .10). Ropinirole was generally well tolerated, with an adverse-event profile consistent with other dopamine agonists. CONCLUSION: This study confirms that ropinirole improves RLS symptoms and subjective measures of sleep, quality of life, and anxiety and that it is generally well tolerated. SN - 0025-6196 UR - https://www.unboundmedicine.com/medline/citation/16438474/Ropinirole_in_the_treatment_of_patients_with_restless_legs_syndrome:_a_US_based_randomized_double_blind_placebo_controlled_clinical_trial_ L2 - https://linkinghub.elsevier.com/retrieve/pii/S0025-6196(11)61631-5 DB - PRIME DP - Unbound Medicine ER -