MovDisordV3, PascalFrancis, Checkpoint, bibRecord, 000A99

Double-Blind Study of Pardoprunox, a New Partial Dopamine Agonist, in Early Parkinson's Disease

Identifieur interne : 000A99 ( PascalFrancis/Checkpoint ); précédent : 000A98; suivant : 000B00

Double-Blind Study of Pardoprunox, a New Partial Dopamine Agonist, in Early Parkinson's Disease

Auteurs : Juliana Bronzova [Pays-Bas] ; Cristina Sampaio [Portugal] ; Robert A. Hauser [États-Unis] ; Anthony E. Lang [Canada] ; Olivier Rascol [France] ; Ad Theeuwes [Pays-Bas] ; Serge V. Van De Witte [Pays-Bas] ; Guus Van Scharrenburg [Pays-Bas]

Source :

Movement disorders [ 0885-3185 ] ; 2010.

RBID : Pascal:10-0233116

Descripteurs français

Pascal (Inist)
- Maladie de Parkinson, Pathologie du système nerveux, Etude double insu, Pardoprunox, Agoniste partiel, Stimulant dopaminergique, Essai clinique.

English descriptors

KwdEn :
- Clinical trial, Dopamine agonist, Double blind study, Nervous system diseases, Pardoprunox, Parkinson disease, Partial agonist.

Abstract

This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9-45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti-Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)-Motor score was improved in pardoprunox-treated patients (overall mean dose 23.8 mg/d; -7.3 points), as compared with placebo (-3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (≥0:30% reduction in UPDRS-Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS-activities of daily living (ADL) and -ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox-treated patients (vs. 3/70, 4.3%, placebo-treated patients), with dizziness, somnolence, headache, and asthenia also reported by ≥10 patients. In this exploratory proof-of-concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD.

Affiliations:

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Pascal:10-0233116

Le document en format XML

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<front><div type="abstract" xml:lang="en">This study examined the efficacy and safety of the partial dopamine agonist, pardoprunox (SLV308), in the treatment of patients with early Parkinson's disease (PD). Patients were randomized to receive pardoprunox (n = 69) or placebo (n = 70). Pardoprunox was titrated to each patient's optimal dose (9-45 mg/d) over 2 to 6 weeks and then maintained at this dose for a further 3 weeks. Concomitant anti-Parkinson treatment was not permitted. In the primary analysis, Unified PD Rating Scale (UPDRS)-Motor score was improved in pardoprunox-treated patients (overall mean dose 23.8 mg/d; -7.3 points), as compared with placebo (-3.0 points; P = 0.0001), from baseline to end point. At end point, there were more responders (≥0:30% reduction in UPDRS-Motor score) in the pardoprunox group (50.7%) than in the placebo group (15.7%; P < 0.0001). In other secondary analyses, UPDRS-activities of daily living (ADL) and -ADL+Motor scores were also significantly more improved in the pardoprunox group. Nausea was reported by 32 of 68 (47.1%) pardoprunox-treated patients (vs. 3/70, 4.3%, placebo-treated patients), with dizziness, somnolence, headache, and asthenia also reported by ≥10 patients. In this exploratory proof-of-concept study, pardoprunox significantly improved motor function in patients with early PD. The efficacy and safety profile of pardoprunox justifies its further investigation in PD.</div>
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<fC03 i1="06" i2="X" l="FRE"><s0>Stimulant dopaminergique</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Dopamine agonist</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Estimulante dopaminérgico</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Essai clinique</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Clinical trial</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Ensayo clínico</s0>
<s5>13</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Pathologie de l'encéphale</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG"><s0>Cerebral disorder</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA"><s0>Encéfalo patología</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE"><s0>Syndrome extrapyramidal</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Extrapyramidal syndrome</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Extrapiramidal síndrome</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Maladie dégénérative</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Degenerative disease</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Pathologie du   système nerveux central</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Central nervous system disease</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0>
<s5>40</s5>
</fC07>
<fN21><s1>158</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
<affiliations><list><country><li>Canada</li>
<li>France</li>
<li>Pays-Bas</li>
<li>Portugal</li>
<li>États-Unis</li>
</country>
<region><li>Floride</li>
<li>Midi-Pyrénées</li>
<li>Ontario</li>
</region>
<settlement><li>Tampa</li>
<li>Toronto</li>
<li>Toulouse</li>
</settlement>
<orgName><li>Université Toulouse III - Paul Sabatier</li>
<li>Université de Floride du Sud</li>
<li>Université de Toronto</li>
<li>Université de Toulouse</li>
</orgName>
</list>
<tree><country name="Pays-Bas"><noRegion><name sortKey="Bronzova, Juliana" sort="Bronzova, Juliana" uniqKey="Bronzova J" first="Juliana" last="Bronzova">Juliana Bronzova</name>
</noRegion>
<name sortKey="Theeuwes, Ad" sort="Theeuwes, Ad" uniqKey="Theeuwes A" first="Ad" last="Theeuwes">Ad Theeuwes</name>
<name sortKey="Van De Witte, Serge V" sort="Van De Witte, Serge V" uniqKey="Van De Witte S" first="Serge V." last="Van De Witte">Serge V. Van De Witte</name>
<name sortKey="Van Scharrenburg, Guus" sort="Van Scharrenburg, Guus" uniqKey="Van Scharrenburg G" first="Guus" last="Van Scharrenburg">Guus Van Scharrenburg</name>
</country>
<country name="Portugal"><noRegion><name sortKey="Sampaio, Cristina" sort="Sampaio, Cristina" uniqKey="Sampaio C" first="Cristina" last="Sampaio">Cristina Sampaio</name>
</noRegion>
</country>
<country name="États-Unis"><region name="Floride"><name sortKey="Hauser, Robert A" sort="Hauser, Robert A" uniqKey="Hauser R" first="Robert A." last="Hauser">Robert A. Hauser</name>
</region>
</country>
<country name="Canada"><region name="Ontario"><name sortKey="Lang, Anthony E" sort="Lang, Anthony E" uniqKey="Lang A" first="Anthony E." last="Lang">Anthony E. Lang</name>
</region>
</country>
<country name="France"><noRegion><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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	Movement Disorders (revue)
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Movement Disorders (revue)

Double-Blind Study of Pardoprunox, a New Partial Dopamine Agonist, in Early Parkinson's Disease

Double-Blind Study of Pardoprunox, a New Partial Dopamine Agonist, in Early Parkinson's Disease

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