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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.

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  • 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

    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 -