Efficacy of pramipexole in restless legs syndrome : A six-week, multicenter, randomized, double-blind study (effect-RLS study)
Identifieur interne : 001806 ( PascalFrancis/Corpus ); précédent : 001805; suivant : 001807Efficacy of pramipexole in restless legs syndrome : A six-week, multicenter, randomized, double-blind study (effect-RLS study)
Auteurs : Wolfgang H. Oertel ; Karin Stiasny-Kolster ; Bettina Bergtholdt ; Yngve Hallström ; Jaan Albo ; Lena Leissner ; Thomas Schindler ; Juergen Koester ; Juergen ReessSource :
- Movement disorders [ 0885-3185 ] ; 2007.
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- Pascal (Inist)
English descriptors
- KwdEn :
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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Format Inist (serveur)
NO : | PASCAL 07-0133246 INIST |
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ET : | Efficacy of pramipexole in restless legs syndrome : A six-week, multicenter, randomized, double-blind study (effect-RLS study) |
AU : | OERTEL (Wolfgang H.); STIASNY-KOLSTER (Karin); BERGTHOLDT (Bettina); HALLSTRÖM (Yngve); ALBO (Jaan); LEISSNER (Lena); SCHINDLER (Thomas); KOESTER (Juergen); REESS (Juergen) |
AF : | Philipps-University Marburg/Marburg/Allemagne (1 aut., 2 aut.); Emovis GmbH/Berlin/Allemagne (3 aut.); Neuro Center/Stockholm/Suède (4 aut.); Läkarhuset Vallingby/Vällingby/Suède (5 aut.); Neurologiska Kliniken/Örebro/Suède (6 aut.); Boehringer Ingelheim Pharma GmbH & Co. KG/Allemagne (7 aut., 8 aut., 9 aut.) |
DT : | Publication en série; Niveau analytique |
SO : | Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2007; Vol. 22; No. 2; Pp. 213-219; Bibl. 14 ref. |
LA : | Anglais |
EA : | 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. |
CC : | 002B17; 002B02Q; 002B17D |
FD : | Système nerveux pathologie; Impatience membre inférieur syndrome; Pramipexole; Etude multicentrique; Etude double insu; Essai clinique; Stimulant dopaminergique |
FG : | Trouble neurologique; Trouble sensibilité |
ED : | Nervous system diseases; Restless legs syndrome; Pramipexole; Multicenter study; Double blind study; Clinical trial; Dopamine agonist |
EG : | Neurological disorder; Sensitivity disorder |
SD : | Sistema nervioso patología; Acroparestesia nocturna; Pramipexol; Estudio multicéntrico; Estudio doble ciego; Ensayo clínico; Estimulante dopaminérgico |
LO : | INIST-20953.354000145528070110 |
ID : | 07-0133246 |
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Pascal:07-0133246Le document en format XML
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<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>
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<server><NO>PASCAL 07-0133246 INIST</NO>
<ET>Efficacy of pramipexole in restless legs syndrome : A six-week, multicenter, randomized, double-blind study (effect-RLS study)</ET>
<AU>OERTEL (Wolfgang H.); STIASNY-KOLSTER (Karin); BERGTHOLDT (Bettina); HALLSTRÖM (Yngve); ALBO (Jaan); LEISSNER (Lena); SCHINDLER (Thomas); KOESTER (Juergen); REESS (Juergen)</AU>
<AF>Philipps-University Marburg/Marburg/Allemagne (1 aut., 2 aut.); Emovis GmbH/Berlin/Allemagne (3 aut.); Neuro Center/Stockholm/Suède (4 aut.); Läkarhuset Vallingby/Vällingby/Suède (5 aut.); Neurologiska Kliniken/Örebro/Suède (6 aut.); Boehringer Ingelheim Pharma GmbH & Co. KG/Allemagne (7 aut., 8 aut., 9 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2007; Vol. 22; No. 2; Pp. 213-219; Bibl. 14 ref.</SO>
<LA>Anglais</LA>
<EA>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.</EA>
<CC>002B17; 002B02Q; 002B17D</CC>
<FD>Système nerveux pathologie; Impatience membre inférieur syndrome; Pramipexole; Etude multicentrique; Etude double insu; Essai clinique; Stimulant dopaminergique</FD>
<FG>Trouble neurologique; Trouble sensibilité</FG>
<ED>Nervous system diseases; Restless legs syndrome; Pramipexole; Multicenter study; Double blind study; Clinical trial; Dopamine agonist</ED>
<EG>Neurological disorder; Sensitivity disorder</EG>
<SD>Sistema nervioso patología; Acroparestesia nocturna; Pramipexol; Estudio multicéntrico; Estudio doble ciego; Ensayo clínico; Estimulante dopaminérgico</SD>
<LO>INIST-20953.354000145528070110</LO>
<ID>07-0133246</ID>
</server>
</inist>
</record>
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