MovDisordV3, PascalFrancis, Curation, bibRecord, 001515

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

Identifieur interne : 001515 ( PascalFrancis/Curation ); précédent : 001514; suivant : 001516

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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<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>
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<s1>© 2007 INIST-CNRS. All rights reserved.</s1>
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<fA66 i1="01"><s0>USA</s0>
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<fC01 i1="01" l="ENG"><s0>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.</s0>
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<fC02 i1="02" i2="X"><s0>002B02Q</s0>
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<s5>02</s5>
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<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
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<fC03 i1="03" i2="X" l="ENG"><s0>Pramipexole</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
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<s5>37</s5>
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<s5>37</s5>
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<s5>37</s5>
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<fC07 i1="02" i2="X" l="FRE"><s0>Trouble sensibilité</s0>
<s5>38</s5>
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<s5>38</s5>
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<fC07 i1="02" i2="X" l="SPA"><s0>Trastorno sensibilidad</s0>
<s5>38</s5>
</fC07>
<fN21><s1>085</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
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<fN82><s1>OTO</s1>
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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)

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