Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: A 12-week, double-blind, randomized, parallel-group, placebo-controlled study
Corresponding Author
Arthur S. Walters MD
New Jersey Neuroscience Institute at JFK Medical Center, Edison, New Jersey, USA
New Jersey Neuroscience Institute at JFK Medical Center, 65 James Street, Edison, NJ 08818Search for more papers by this authorWilliam G. Ondo MD
Baylor College of Medicine, Houston, Texas, USA
Search for more papers by this authorTilman Dreykluft MD
Klinische Forschung Berlin, Berlin, Germany
Search for more papers by this authorRon Grunstein MD, PhD
Woolcock Institute of Medical Research, Royal Prince Alfred Hospital and University of Sydney, New South Wales, Australia
Search for more papers by this authorDaniel Lee MD
East Carolina Neurology, Greenville, North Carolina, USA
Search for more papers by this authorKapil Sethi MD, FRCP(UK)
Medical College of Georgia, Augusta, Georgia, USA
Search for more papers by this authoron behalf of the TREAT RLS 2 (Therapy with Ropinirole: Efficacy And Tolerability in RLS 2) Study Group
Search for more papers by this authorCorresponding Author
Arthur S. Walters MD
New Jersey Neuroscience Institute at JFK Medical Center, Edison, New Jersey, USA
New Jersey Neuroscience Institute at JFK Medical Center, 65 James Street, Edison, NJ 08818Search for more papers by this authorWilliam G. Ondo MD
Baylor College of Medicine, Houston, Texas, USA
Search for more papers by this authorTilman Dreykluft MD
Klinische Forschung Berlin, Berlin, Germany
Search for more papers by this authorRon Grunstein MD, PhD
Woolcock Institute of Medical Research, Royal Prince Alfred Hospital and University of Sydney, New South Wales, Australia
Search for more papers by this authorDaniel Lee MD
East Carolina Neurology, Greenville, North Carolina, USA
Search for more papers by this authorKapil Sethi MD, FRCP(UK)
Medical College of Georgia, Augusta, Georgia, USA
Search for more papers by this authoron behalf of the TREAT RLS 2 (Therapy with Ropinirole: Efficacy And Tolerability in RLS 2) Study Group
Search for more papers by this authorAbstract
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. © 2004 Movement Disorder Society
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