MovDisordV3, Main, Merge, bibRecord, 004278

Efficacy of pramipexole in restless legs syndrome : A six-week, multicenter, randomized, double-blind study (effect-RLS study)

Identifieur interne : 004278 ( Main/Merge ); précédent : 004277; suivant : 004279

Efficacy of pramipexole in restless legs syndrome : A six-week, multicenter, randomized, double-blind study (effect-RLS study)

Auteurs : Wolfgang H. Oertel [Allemagne] ; Karin Stiasny-Kolster [Allemagne] ; Bettina Bergtholdt [Allemagne] ; Yngve Hallström [Suède] ; Jaan Albo [Suède] ; Lena Leissner [Suède] ; Thomas Schindler [Allemagne] ; Juergen Koester [Allemagne] ; Juergen Reess [Allemagne]

Source :

Movement disorders [ 0885-3185 ] ; 2007.

RBID : Pascal:07-0133246

Descripteurs français

Pascal (Inist)
- Système nerveux pathologie, Impatience membre inférieur syndrome, Pramipexole, Etude multicentrique, Etude double insu, Essai clinique, Stimulant dopaminergique.

English descriptors

KwdEn :
- Clinical trial, Dopamine agonist, Double blind study, Multicenter study, Nervous system diseases, Pramipexole, Restless legs syndrome.

Abstract

We evaluated the efficacy of pramipexole versus placebo in restless legs syndrome (RLS) for 6 weeks. Overall, 345 patients were randomly assigned in a 1:2 ratio to receive either placebo (n = 115) or pramipexole (n = 230) with a starting dose of 0.125 mg/day. The dose was individually optimized according to the Patient Global Impression (PGI) assessment, up to a maximum of 0.75 mg/day. The primary endpoint consisted of two assessments: the change from baseline in the International RLS Study Group Rating Scale (IRLS) and the proportion of patients with Clinical Global Impressions-Improvement (CGI-I) assessments of "much/very much improved" (CGI-I responders) at week 6. Secondary endpoints included PGI and IRLS responder rates. Patient demographics and baseline characteristics were comparable between treatment groups. At baseline, mean IRLS scores were 24.9 (placebo) and 24.7 (pramipexole), representing severely affected patients. After 6 weeks, adjusted mean reductions (±SE) in IRLS score were 5.7 (±0.9) for placebo (median dose 0.47 mg/day) and 12.3 (±0.6) for pramipexole (median dose 0.35 mg/day; P < 0.0001). CGI-I responder rates were 32.5% (placebo) and 62.9% (pramipexole) (P < 0.0001). For all secondary endpoints, pramipexole showed superior results. Pramipexole was well tolerated throughout the study.

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Pascal:07-0133246

Le document en format XML

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<series><title level="j" type="main">Movement disorders</title>
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<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical trial</term>
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<keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term>
<term>Impatience membre inférieur syndrome</term>
<term>Pramipexole</term>
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<term>Etude double insu</term>
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<front><div type="abstract" xml:lang="en">We evaluated the efficacy of pramipexole versus placebo in restless legs syndrome (RLS) for 6 weeks. Overall, 345 patients were randomly assigned in a 1:2 ratio to receive either placebo (n = 115) or pramipexole (n = 230) with a starting dose of 0.125 mg/day. The dose was individually optimized according to the Patient Global Impression (PGI) assessment, up to a maximum of 0.75 mg/day. The primary endpoint consisted of two assessments: the change from baseline in the International RLS Study Group Rating Scale (IRLS) and the proportion of patients with Clinical Global Impressions-Improvement (CGI-I) assessments of "much/very much improved" (CGI-I responders) at week 6. Secondary endpoints included PGI and IRLS responder rates. Patient demographics and baseline characteristics were comparable between treatment groups. At baseline, mean IRLS scores were 24.9 (placebo) and 24.7 (pramipexole), representing severely affected patients. After 6 weeks, adjusted mean reductions (±SE) in IRLS score were 5.7 (±0.9) for placebo (median dose 0.47 mg/day) and 12.3 (±0.6) for pramipexole (median dose 0.35 mg/day; P < 0.0001). CGI-I responder rates were 32.5% (placebo) and 62.9% (pramipexole) (P < 0.0001). For all secondary endpoints, pramipexole showed superior results. Pramipexole was well tolerated throughout the study.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Suède</li>
</country>
<region><li>Berlin</li>
<li>District de Giessen</li>
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<tree><country name="Allemagne"><region name="Hesse (Land)"><name sortKey="Oertel, Wolfgang H" sort="Oertel, Wolfgang H" uniqKey="Oertel W" first="Wolfgang H." last="Oertel">Wolfgang H. Oertel</name>
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<name sortKey="Bergtholdt, Bettina" sort="Bergtholdt, Bettina" uniqKey="Bergtholdt B" first="Bettina" last="Bergtholdt">Bettina Bergtholdt</name>
<name sortKey="Koester, Juergen" sort="Koester, Juergen" uniqKey="Koester J" first="Juergen" last="Koester">Juergen Koester</name>
<name sortKey="Reess, Juergen" sort="Reess, Juergen" uniqKey="Reess J" first="Juergen" last="Reess">Juergen Reess</name>
<name sortKey="Schindler, Thomas" sort="Schindler, Thomas" uniqKey="Schindler T" first="Thomas" last="Schindler">Thomas Schindler</name>
<name sortKey="Stiasny Kolster, Karin" sort="Stiasny Kolster, Karin" uniqKey="Stiasny Kolster K" first="Karin" last="Stiasny-Kolster">Karin Stiasny-Kolster</name>
</country>
<country name="Suède"><region name="Svealand"><name sortKey="Hallstrom, Yngve" sort="Hallstrom, Yngve" uniqKey="Hallstrom Y" first="Yngve" last="Hallström">Yngve Hallström</name>
</region>
<name sortKey="Albo, Jaan" sort="Albo, Jaan" uniqKey="Albo J" first="Jaan" last="Albo">Jaan Albo</name>
<name sortKey="Leissner, Lena" sort="Leissner, Lena" uniqKey="Leissner L" first="Lena" last="Leissner">Lena Leissner</name>
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</record>

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	Movement Disorders (revue)
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Movement Disorders (revue)

Efficacy of pramipexole in restless legs syndrome : A six-week, multicenter, randomized, double-blind study (effect-RLS study)

Efficacy of pramipexole in restless legs syndrome : A six-week, multicenter, randomized, double-blind study (effect-RLS study)

Source :

Descripteurs français

English descriptors

Abstract

Links toward previous steps (curation, corpus...)

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