Movement Disorders (revue)

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

Identifieur interne : 001688 ( PascalFrancis/Checkpoint ); précédent : 001687; suivant : 001689

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 :

RBID : Pascal:07-0133246

Descripteurs français

English descriptors

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

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<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Acroparestesia nocturna</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE">
<s0>Pramipexole</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Pramipexole</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Pramipexol</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Etude multicentrique</s0>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Multicenter study</s0>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Estudio multicéntrico</s0>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Etude double insu</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Double blind study</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Estudio doble ciego</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Essai clinique</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Clinical trial</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Ensayo clínico</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Stimulant dopaminergique</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Dopamine agonist</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Estimulante dopaminérgico</s0>
<s5>13</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Trouble neurologique</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Neurological disorder</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Trastorno neurológico</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Trouble sensibilité</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Sensitivity disorder</s0>
<s5>38</s5>
</fC07>
<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>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
<affiliations>
<list>
<country>
<li>Allemagne</li>
<li>Suède</li>
</country>
<region>
<li>Berlin</li>
<li>District de Giessen</li>
<li>Hesse (Land)</li>
<li>Svealand</li>
</region>
<settlement>
<li>Berlin</li>
<li>Marbourg</li>
<li>Stockholm</li>
</settlement>
</list>
<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>
</region>
<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>
</country>
</tree>
</affiliations>
</record>

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