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Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study.
Mov Disord. 2004 Dec; 19(12):1414-23.MD

Abstract

Restless legs syndrome (RLS) is a neurological condition with significant impact on sleep and quality of life (QoL). This double-blind, randomized, 12-week, multinational study compared the efficacy and safety of ropinirole and placebo in RLS. In total, 267 outpatients with moderate-to-severe RLS were randomly assigned to ropinirole (0.25-4.0 mg/day) or placebo, 1 to 3 hours before bedtime. The primary endpoint was the change in International Restless Legs Scale (IRLS) score at week 12. Key secondary endpoints were the percentage of patients showing significant improvement on the Clinical Global Impression-Improvement (CGI-I) scale at week 12 and changes in IRLS and CGI-I scale scores at week 1. Other measures included the Medical Outcomes Study sleep scale and Restless Legs Syndrome Quality of Life questionnaire. Improvements were significantly greater for ropinirole than placebo for change in IRLS score at week 12 (-11.2 [SE 0.76] vs. -8.7 [0.75], respectively; adjusted treatment difference -2.5 [95% confidence interval [CI], -4.6, -0.4], P = 0.0197); all key secondary endpoints; sleep and QoL parameters. Adverse events were typical for dopamine agonists; disease augmentation, although not directly assessed, was not reported during treatment. Ropinirole improves symptoms, associated sleep disturbance, and QoL of RLS patients and is generally well tolerated.

Links

Publisher Full Text

Authors+Show Affiliations

Walters AS
New Jersey Neuroscience Institute at JFK Medical Center, Edison, New Jersey 08818, USA. artumdnj@aol.com
Ondo WG
No affiliation info available
Dreykluft T
No affiliation info available
Grunstein R
No affiliation info available
Lee D
No affiliation info available
Sethi K
No affiliation info available
TREAT RLS 2 (Therapy with Ropinirole: Efficacy And Tolerability in RLS 2) Study Group
No affiliation info available

MeSH

AdolescentAdultAgedDopamine AgentsDouble-Blind MethodFemaleHumansIndolesMaleMiddle AgedQuality of LifeRestless Legs Syndrome

Pub Type(s)

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

Language

eng

PubMed ID

15390050

Clinical Trial Links

RESTIFFIC™ Foot Wrap Reduces Moderate to Severe Restless Leg Syndrome

Citation

Walters, Arthur S., et al. "Ropinirole Is Effective in the Treatment of Restless Legs Syndrome. TREAT RLS 2: a 12-week, Double-blind, Randomized, Parallel-group, Placebo-controlled Study." Movement Disorders : Official Journal of the Movement Disorder Society, vol. 19, no. 12, 2004, pp. 1414-23.
Walters AS, Ondo WG, Dreykluft T, et al. Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study. Mov Disord. 2004;19(12):1414-23.
Walters, A. S., Ondo, W. G., Dreykluft, T., Grunstein, R., Lee, D., & Sethi, K. (2004). Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study. Movement Disorders : Official Journal of the Movement Disorder Society, 19(12), 1414-23.
Walters AS, et al. Ropinirole Is Effective in the Treatment of Restless Legs Syndrome. TREAT RLS 2: a 12-week, Double-blind, Randomized, Parallel-group, Placebo-controlled Study. Mov Disord. 2004;19(12):1414-23. PubMed PMID: 15390050.
* Article titles in AMA citation format should be in sentence-case
TY - JOUR T1 - Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study. AU - Walters,Arthur S, AU - Ondo,William G, AU - Dreykluft,Tilman, AU - Grunstein,Ron, AU - Lee,Daniel, AU - Sethi,Kapil, AU - ,, PY - 2004/9/25/pubmed PY - 2005/4/9/medline PY - 2004/9/25/entrez SP - 1414 EP - 23 JF - Movement disorders : official journal of the Movement Disorder Society JO - Mov Disord VL - 19 IS - 12 N2 - Restless legs syndrome (RLS) is a neurological condition with significant impact on sleep and quality of life (QoL). This double-blind, randomized, 12-week, multinational study compared the efficacy and safety of ropinirole and placebo in RLS. In total, 267 outpatients with moderate-to-severe RLS were randomly assigned to ropinirole (0.25-4.0 mg/day) or placebo, 1 to 3 hours before bedtime. The primary endpoint was the change in International Restless Legs Scale (IRLS) score at week 12. Key secondary endpoints were the percentage of patients showing significant improvement on the Clinical Global Impression-Improvement (CGI-I) scale at week 12 and changes in IRLS and CGI-I scale scores at week 1. Other measures included the Medical Outcomes Study sleep scale and Restless Legs Syndrome Quality of Life questionnaire. Improvements were significantly greater for ropinirole than placebo for change in IRLS score at week 12 (-11.2 [SE 0.76] vs. -8.7 [0.75], respectively; adjusted treatment difference -2.5 [95% confidence interval [CI], -4.6, -0.4], P = 0.0197); all key secondary endpoints; sleep and QoL parameters. Adverse events were typical for dopamine agonists; disease augmentation, although not directly assessed, was not reported during treatment. Ropinirole improves symptoms, associated sleep disturbance, and QoL of RLS patients and is generally well tolerated. SN - 0885-3185 UR - https://www.unboundmedicine.com/medline/citation/15390050/Ropinirole_is_effective_in_the_treatment_of_restless_legs_syndrome__TREAT_RLS_2:_a_12_week_double_blind_randomized_parallel_group_placebo_controlled_study_ L2 - https://doi.org/10.1002/mds.20257 DB - PRIME DP - Unbound Medicine ER -