MovDisordV3, PubMed, Corpus, bibRecord, 003263

Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study.

Identifieur interne : 003263 ( PubMed/Corpus ); précédent : 003262; suivant : 003264

Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study.

Auteurs : Arthur S. Walters ; William G. Ondo ; Tilman Dreykluft ; Ron Grunstein ; Daniel Lee ; Kapil Sethi

Source :

Movement disorders : official journal of the Movement Disorder Society [ 0885-3185 ] ; 2004.

RBID : pubmed:15390050

English descriptors

KwdEn :
- Adolescent, Adult, Aged, Dopamine Agents (adverse effects), Dopamine Agents (therapeutic use), Double-Blind Method, Female, Humans, Indoles (adverse effects), Indoles (therapeutic use), Male, Middle Aged, Quality of Life, Restless Legs Syndrome (drug therapy).
MESH :
- chemical , adverse effects : Dopamine Agents, Indoles.
- chemical , therapeutic use : Dopamine Agents, Indoles.
- drug therapy : Restless Legs Syndrome.
- Adolescent, Adult, Aged, Double-Blind Method, Female, Humans, Male, Middle Aged, Quality of Life.

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.

DOI: 10.1002/mds.20257
PubMed: 15390050

Links to Exploration step

pubmed:15390050

Le document en format XML

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<author><name sortKey="Walters, Arthur S" sort="Walters, Arthur S" uniqKey="Walters A" first="Arthur S" last="Walters">Arthur S. Walters</name>
<affiliation><nlm:affiliation>New Jersey Neuroscience Institute at JFK Medical Center, Edison, New Jersey 08818, USA. artumdnj@aol.com</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Ondo, William G" sort="Ondo, William G" uniqKey="Ondo W" first="William G" last="Ondo">William G. Ondo</name>
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<author><name sortKey="Dreykluft, Tilman" sort="Dreykluft, Tilman" uniqKey="Dreykluft T" first="Tilman" last="Dreykluft">Tilman Dreykluft</name>
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<author><name sortKey="Grunstein, Ron" sort="Grunstein, Ron" uniqKey="Grunstein R" first="Ron" last="Grunstein">Ron Grunstein</name>
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<author><name sortKey="Lee, Daniel" sort="Lee, Daniel" uniqKey="Lee D" first="Daniel" last="Lee">Daniel Lee</name>
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<author><name sortKey="Sethi, Kapil" sort="Sethi, Kapil" uniqKey="Sethi K" first="Kapil" last="Sethi">Kapil Sethi</name>
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<author><name sortKey="Ondo, William G" sort="Ondo, William G" uniqKey="Ondo W" first="William G" last="Ondo">William G. Ondo</name>
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<author><name sortKey="Sethi, Kapil" sort="Sethi, Kapil" uniqKey="Sethi K" first="Kapil" last="Sethi">Kapil Sethi</name>
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<term>Adult</term>
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<term>Dopamine Agents (therapeutic use)</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
<term>Indoles (adverse effects)</term>
<term>Indoles (therapeutic use)</term>
<term>Male</term>
<term>Middle Aged</term>
<term>Quality of Life</term>
<term>Restless Legs Syndrome (drug therapy)</term>
</keywords>
<keywords scheme="MESH" type="chemical" qualifier="adverse effects" xml:lang="en"><term>Dopamine Agents</term>
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<keywords scheme="MESH" type="chemical" qualifier="therapeutic use" xml:lang="en"><term>Dopamine Agents</term>
<term>Indoles</term>
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<keywords scheme="MESH" xml:lang="en"><term>Adolescent</term>
<term>Adult</term>
<term>Aged</term>
<term>Double-Blind Method</term>
<term>Female</term>
<term>Humans</term>
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<front><div type="abstract" xml:lang="en">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.</div>
</front>
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<Title>Movement disorders : official journal of the Movement Disorder Society</Title>
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<ArticleTitle>Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study.</ArticleTitle>
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<Abstract><AbstractText>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.</AbstractText>
<CopyrightInformation>2004 Movement Disorder Society.</CopyrightInformation>
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	Movement Disorders (revue)
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Movement Disorders (revue)

Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study.

Ropinirole is effective in the treatment of restless legs syndrome. TREAT RLS 2: a 12-week, double-blind, randomized, parallel-group, placebo-controlled study.

Source :

English descriptors

Abstract

Links to Exploration step

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri

Pour générer des pages wiki