Sarizotan as a treatment for dyskinesias in Parkinson's disease : A double-blind placebo-controlled trial
Identifieur interne : 001812 ( PascalFrancis/Corpus ); précédent : 001811; suivant : 001813Sarizotan as a treatment for dyskinesias in Parkinson's disease : A double-blind placebo-controlled trial
Auteurs : Christopher G. Goetz ; Philippe Damier ; Christine Hicking ; Eugene Laska ; Thomas Müller ; C. Warren Olanow ; Olivier Rascol ; Hermann RussSource :
- Movement disorders [ 0885-3185 ] ; 2007.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
Abstract
The objective of this study is to conduct a dose-finding study of sarizotan in Parkinson's disease (PD) patients with dyskinesia to identify a safe dose and to identify a sensitive dyskinesia rating measure. Sarizotan is a novel compound with full 5-HT1A agonist properties and additional high affinity for D3 and D4 receptors. An open label study documented improvements in PD patients with levodopa-induced dyskinesia. There is no precedent for study designs or outcome measures in pivotal trials of antidyskinesia therapies. The approach used here was a multicenter, randomized, placebo-controlled, double-blind, parallel study. Included were PD patients optimized to levodopa and dopaminergic drugs with moderately disabling dyskinesias present greater than or equal to 25% of the waking day. Interventions included sarizotan 2, 4, or 10 mg/day or matching placebo, given in two doses. There were two outcome measures: the primary measure was change from baseline in diary-based on time without dyskinesia; the secondary measures were change from baseline in scores on the Abnormal Involuntary Movement Scale (AIMS), the composite score of Unified Parkinson's Disease Rating Scale (UPDRS) Items 32+33 (dyskinesia duration and disability) and total UPDRS. A total of 398 subjects were randomized, with 381 included in the intention-to-treat population. No significant changes occurred on sarizotan compared to placebo on any diary-based measure of dyskinesia or the AIMS score. The composite score of UPDRS Items 32+33 was significantly improved with 2 mg/day sarizotan, with a trend at 10 mg/day. Adverse events were not significantly different in sarizotan-and placebo-treated patients, but off time significantly increased with sarizotan 10 mg/day. Sarizotan 2 mg/day is a safe agent in PD patients with dyskinesia. To test its role in abating dyskinesia, future studies should focus on this dose and will use the composite score of UPDRS Items 32+33 as the primary outcome.
Notice en format standard (ISO 2709)
Pour connaître la documentation sur le format Inist Standard.
| pA |
|
|---|
Format Inist (serveur)
| NO : | PASCAL 07-0133240 INIST |
|---|---|
| ET : | Sarizotan as a treatment for dyskinesias in Parkinson's disease : A double-blind placebo-controlled trial |
| AU : | GOETZ (Christopher G.); DAMIER (Philippe); HICKING (Christine); LASKA (Eugene); MÜLLER (Thomas); OLANOW (C. Warren); RASCOL (Olivier); RUSS (Hermann) |
| AF : | Rush University Medical Center/Chicago, Illinois/Etats-Unis (1 aut.); Hôpital Guillaume et Rend Laennec/Nantes/France (2 aut.); Merck KGaA/Darmstadt/Allemagne (3 aut., 8 aut.); New York University School of Medicine, New York, and Nathan Kline Institute/Orangeburg, New York/Etats-Unis (4 aut.); Ruhr University/Bochum/Allemagne (5 aut.); Mount Sinai School of Medicine/New York, New York/Etats-Unis (6 aut.); Toulouse University Hospital/Toulouse/France (7 aut.) |
| DT : | Publication en série; Niveau analytique |
| SO : | Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2007; Vol. 22; No. 2; Pp. 179-186; Bibl. 15 ref. |
| LA : | Anglais |
| EA : | The objective of this study is to conduct a dose-finding study of sarizotan in Parkinson's disease (PD) patients with dyskinesia to identify a safe dose and to identify a sensitive dyskinesia rating measure. Sarizotan is a novel compound with full 5-HT1A agonist properties and additional high affinity for D3 and D4 receptors. An open label study documented improvements in PD patients with levodopa-induced dyskinesia. There is no precedent for study designs or outcome measures in pivotal trials of antidyskinesia therapies. The approach used here was a multicenter, randomized, placebo-controlled, double-blind, parallel study. Included were PD patients optimized to levodopa and dopaminergic drugs with moderately disabling dyskinesias present greater than or equal to 25% of the waking day. Interventions included sarizotan 2, 4, or 10 mg/day or matching placebo, given in two doses. There were two outcome measures: the primary measure was change from baseline in diary-based on time without dyskinesia; the secondary measures were change from baseline in scores on the Abnormal Involuntary Movement Scale (AIMS), the composite score of Unified Parkinson's Disease Rating Scale (UPDRS) Items 32+33 (dyskinesia duration and disability) and total UPDRS. A total of 398 subjects were randomized, with 381 included in the intention-to-treat population. No significant changes occurred on sarizotan compared to placebo on any diary-based measure of dyskinesia or the AIMS score. The composite score of UPDRS Items 32+33 was significantly improved with 2 mg/day sarizotan, with a trend at 10 mg/day. Adverse events were not significantly different in sarizotan-and placebo-treated patients, but off time significantly increased with sarizotan 10 mg/day. Sarizotan 2 mg/day is a safe agent in PD patients with dyskinesia. To test its role in abating dyskinesia, future studies should focus on this dose and will use the composite score of UPDRS Items 32+33 as the primary outcome. |
| CC : | 002B17; 002B17G; 002B02U01 |
| FD : | Système nerveux pathologie; Dyskinésie; Parkinson maladie; Sarizotan; Traitement; Placebo; Essai clinique |
| FG : | Extrapyramidal syndrome; Mouvement involontaire; Trouble neurologique; Encéphale pathologie; Maladie dégénérative; Système nerveux central pathologie |
| ED : | Nervous system diseases; Dyskinesia; Parkinson disease; Sarizotan; Treatment; Placebo; Clinical trial |
| EG : | Extrapyramidal syndrome; Involuntary movement; Neurological disorder; Cerebral disorder; Degenerative disease; Central nervous system disease |
| SD : | Sistema nervioso patología; Disquinesia; Parkinson enfermedad; Sarizotán; Tratamiento; Placebo; Ensayo clínico |
| LO : | INIST-20953.354000145528070050 |
| ID : | 07-0133240 |
Links to Exploration step
Pascal:07-0133240Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Sarizotan as a treatment for dyskinesias in Parkinson's disease : A double-blind placebo-controlled trial</title><author><name sortKey="Goetz, Christopher G" sort="Goetz, Christopher G" uniqKey="Goetz C" first="Christopher G." last="Goetz">Christopher G. Goetz</name><affiliation><inist:fA14 i1="01"><s1>Rush University Medical Center</s1><s2>Chicago, Illinois</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Damier, Philippe" sort="Damier, Philippe" uniqKey="Damier P" first="Philippe" last="Damier">Philippe Damier</name><affiliation><inist:fA14 i1="02"><s1>Hôpital Guillaume et Rend Laennec</s1><s2>Nantes</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Hicking, Christine" sort="Hicking, Christine" uniqKey="Hicking C" first="Christine" last="Hicking">Christine Hicking</name><affiliation><inist:fA14 i1="03"><s1>Merck KGaA</s1><s2>Darmstadt</s2><s3>DEU</s3><sZ>3 aut.</sZ><sZ>8 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Laska, Eugene" sort="Laska, Eugene" uniqKey="Laska E" first="Eugene" last="Laska">Eugene Laska</name><affiliation><inist:fA14 i1="04"><s1>New York University School of Medicine, New York, and Nathan Kline Institute</s1><s2>Orangeburg, New York</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Muller, Thomas" sort="Muller, Thomas" uniqKey="Muller T" first="Thomas" last="Müller">Thomas Müller</name><affiliation><inist:fA14 i1="05"><s1>Ruhr University</s1><s2>Bochum</s2><s3>DEU</s3><sZ>5 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C. Warren" last="Olanow">C. Warren Olanow</name><affiliation><inist:fA14 i1="06"><s1>Mount Sinai School of Medicine</s1><s2>New York, New York</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation><inist:fA14 i1="07"><s1>Toulouse University Hospital</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>7 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Russ, Hermann" sort="Russ, Hermann" uniqKey="Russ H" first="Hermann" last="Russ">Hermann Russ</name><affiliation><inist:fA14 i1="03"><s1>Merck KGaA</s1><s2>Darmstadt</s2><s3>DEU</s3><sZ>3 aut.</sZ><sZ>8 aut.</sZ></inist:fA14></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">07-0133240</idno><date when="2007">2007</date><idno type="stanalyst">PASCAL 07-0133240 INIST</idno><idno type="RBID">Pascal:07-0133240</idno><idno type="wicri:Area/PascalFrancis/Corpus">001812</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Sarizotan as a treatment for dyskinesias in Parkinson's disease : A double-blind placebo-controlled trial</title><author><name sortKey="Goetz, Christopher G" sort="Goetz, Christopher G" uniqKey="Goetz C" first="Christopher G." last="Goetz">Christopher G. Goetz</name><affiliation><inist:fA14 i1="01"><s1>Rush University Medical Center</s1><s2>Chicago, Illinois</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Damier, Philippe" sort="Damier, Philippe" uniqKey="Damier P" first="Philippe" last="Damier">Philippe Damier</name><affiliation><inist:fA14 i1="02"><s1>Hôpital Guillaume et Rend Laennec</s1><s2>Nantes</s2><s3>FRA</s3><sZ>2 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Hicking, Christine" sort="Hicking, Christine" uniqKey="Hicking C" first="Christine" last="Hicking">Christine Hicking</name><affiliation><inist:fA14 i1="03"><s1>Merck KGaA</s1><s2>Darmstadt</s2><s3>DEU</s3><sZ>3 aut.</sZ><sZ>8 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Laska, Eugene" sort="Laska, Eugene" uniqKey="Laska E" first="Eugene" last="Laska">Eugene Laska</name><affiliation><inist:fA14 i1="04"><s1>New York University School of Medicine, New York, and Nathan Kline Institute</s1><s2>Orangeburg, New York</s2><s3>USA</s3><sZ>4 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Muller, Thomas" sort="Muller, Thomas" uniqKey="Muller T" first="Thomas" last="Müller">Thomas Müller</name><affiliation><inist:fA14 i1="05"><s1>Ruhr University</s1><s2>Bochum</s2><s3>DEU</s3><sZ>5 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Olanow, C Warren" sort="Olanow, C Warren" uniqKey="Olanow C" first="C. Warren" last="Olanow">C. Warren Olanow</name><affiliation><inist:fA14 i1="06"><s1>Mount Sinai School of Medicine</s1><s2>New York, New York</s2><s3>USA</s3><sZ>6 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation><inist:fA14 i1="07"><s1>Toulouse University Hospital</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>7 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Russ, Hermann" sort="Russ, Hermann" uniqKey="Russ H" first="Hermann" last="Russ">Hermann Russ</name><affiliation><inist:fA14 i1="03"><s1>Merck KGaA</s1><s2>Darmstadt</s2><s3>DEU</s3><sZ>3 aut.</sZ><sZ>8 aut.</sZ></inist:fA14></affiliation></author></analytic><series><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno><imprint><date when="2007">2007</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Clinical trial</term><term>Dyskinesia</term><term>Nervous system diseases</term><term>Parkinson disease</term><term>Placebo</term><term>Sarizotan</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Système nerveux pathologie</term><term>Dyskinésie</term><term>Parkinson maladie</term><term>Sarizotan</term><term>Traitement</term><term>Placebo</term><term>Essai clinique</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">The objective of this study is to conduct a dose-finding study of sarizotan in Parkinson's disease (PD) patients with dyskinesia to identify a safe dose and to identify a sensitive dyskinesia rating measure. Sarizotan is a novel compound with full 5-HT<sub>1A</sub> agonist properties and additional high affinity for D<sub>3</sub> and D<sub>4</sub> receptors. An open label study documented improvements in PD patients with levodopa-induced dyskinesia. There is no precedent for study designs or outcome measures in pivotal trials of antidyskinesia therapies. The approach used here was a multicenter, randomized, placebo-controlled, double-blind, parallel study. Included were PD patients optimized to levodopa and dopaminergic drugs with moderately disabling dyskinesias present greater than or equal to 25% of the waking day. Interventions included sarizotan 2, 4, or 10 mg/day or matching placebo, given in two doses. There were two outcome measures: the primary measure was change from baseline in diary-based on time without dyskinesia; the secondary measures were change from baseline in scores on the Abnormal Involuntary Movement Scale (AIMS), the composite score of Unified Parkinson's Disease Rating Scale (UPDRS) Items 32+33 (dyskinesia duration and disability) and total UPDRS. A total of 398 subjects were randomized, with 381 included in the intention-to-treat population. No significant changes occurred on sarizotan compared to placebo on any diary-based measure of dyskinesia or the AIMS score. The composite score of UPDRS Items 32+33 was significantly improved with 2 mg/day sarizotan, with a trend at 10 mg/day. Adverse events were not significantly different in sarizotan-and placebo-treated patients, but off time significantly increased with sarizotan 10 mg/day. Sarizotan 2 mg/day is a safe agent in PD patients with dyskinesia. To test its role in abating dyskinesia, future studies should focus on this dose and will use the composite score of UPDRS Items 32+33 as the primary outcome.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0885-3185</s0></fA01><fA03 i2="1"><s0>Mov. disord.</s0></fA03><fA05><s2>22</s2></fA05><fA06><s2>2</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Sarizotan as a treatment for dyskinesias in Parkinson's disease : A double-blind placebo-controlled trial</s1></fA08><fA11 i1="01" i2="1"><s1>GOETZ (Christopher G.)</s1></fA11><fA11 i1="02" i2="1"><s1>DAMIER (Philippe)</s1></fA11><fA11 i1="03" i2="1"><s1>HICKING (Christine)</s1></fA11><fA11 i1="04" i2="1"><s1>LASKA (Eugene)</s1></fA11><fA11 i1="05" i2="1"><s1>MÜLLER (Thomas)</s1></fA11><fA11 i1="06" i2="1"><s1>OLANOW (C. Warren)</s1></fA11><fA11 i1="07" i2="1"><s1>RASCOL (Olivier)</s1></fA11><fA11 i1="08" i2="1"><s1>RUSS (Hermann)</s1></fA11><fA14 i1="01"><s1>Rush University Medical Center</s1><s2>Chicago, Illinois</s2><s3>USA</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Hôpital Guillaume et Rend Laennec</s1><s2>Nantes</s2><s3>FRA</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>Merck KGaA</s1><s2>Darmstadt</s2><s3>DEU</s3><sZ>3 aut.</sZ><sZ>8 aut.</sZ></fA14><fA14 i1="04"><s1>New York University School of Medicine, New York, and Nathan Kline Institute</s1><s2>Orangeburg, New York</s2><s3>USA</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Ruhr University</s1><s2>Bochum</s2><s3>DEU</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>Mount Sinai School of Medicine</s1><s2>New York, New York</s2><s3>USA</s3><sZ>6 aut.</sZ></fA14><fA14 i1="07"><s1>Toulouse University Hospital</s1><s2>Toulouse</s2><s3>FRA</s3><sZ>7 aut.</sZ></fA14><fA20><s1>179-186</s1></fA20><fA21><s1>2007</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20953</s2><s5>354000145528070050</s5></fA43><fA44><s0>0000</s0><s1>© 2007 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>15 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>07-0133240</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Movement disorders</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>The objective of this study is to conduct a dose-finding study of sarizotan in Parkinson's disease (PD) patients with dyskinesia to identify a safe dose and to identify a sensitive dyskinesia rating measure. Sarizotan is a novel compound with full 5-HT<sub>1A</sub> agonist properties and additional high affinity for D<sub>3</sub> and D<sub>4</sub> receptors. An open label study documented improvements in PD patients with levodopa-induced dyskinesia. There is no precedent for study designs or outcome measures in pivotal trials of antidyskinesia therapies. The approach used here was a multicenter, randomized, placebo-controlled, double-blind, parallel study. Included were PD patients optimized to levodopa and dopaminergic drugs with moderately disabling dyskinesias present greater than or equal to 25% of the waking day. Interventions included sarizotan 2, 4, or 10 mg/day or matching placebo, given in two doses. There were two outcome measures: the primary measure was change from baseline in diary-based on time without dyskinesia; the secondary measures were change from baseline in scores on the Abnormal Involuntary Movement Scale (AIMS), the composite score of Unified Parkinson's Disease Rating Scale (UPDRS) Items 32+33 (dyskinesia duration and disability) and total UPDRS. A total of 398 subjects were randomized, with 381 included in the intention-to-treat population. No significant changes occurred on sarizotan compared to placebo on any diary-based measure of dyskinesia or the AIMS score. The composite score of UPDRS Items 32+33 was significantly improved with 2 mg/day sarizotan, with a trend at 10 mg/day. Adverse events were not significantly different in sarizotan-and placebo-treated patients, but off time significantly increased with sarizotan 10 mg/day. Sarizotan 2 mg/day is a safe agent in PD patients with dyskinesia. To test its role in abating dyskinesia, future studies should focus on this dose and will use the composite score of UPDRS Items 32+33 as the primary outcome.</s0></fC01><fC02 i1="01" i2="X"><s0>002B17</s0></fC02><fC02 i1="02" i2="X"><s0>002B17G</s0></fC02><fC02 i1="03" i2="X"><s0>002B02U01</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Système nerveux pathologie</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Nervous system diseases</s0><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Sistema nervioso patología</s0><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Dyskinésie</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Dyskinesia</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Disquinesia</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Parkinson maladie</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Parkinson disease</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Parkinson enfermedad</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Sarizotan</s0><s2>NK</s2><s2>FR</s2><s5>09</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Sarizotan</s0><s2>NK</s2><s2>FR</s2><s5>09</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Sarizotán</s0><s2>NK</s2><s2>FR</s2><s5>09</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Traitement</s0><s5>10</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Treatment</s0><s5>10</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Tratamiento</s0><s5>10</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Placebo</s0><s5>11</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Placebo</s0><s5>11</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Placebo</s0><s5>11</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Essai clinique</s0><s5>12</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Clinical trial</s0><s5>12</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Ensayo clínico</s0><s5>12</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Extrapyramidal syndrome</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Extrapyramidal syndrome</s0><s5>37</s5></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Extrapiramidal síndrome</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Mouvement involontaire</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Involuntary movement</s0><s5>38</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Movimiento involuntario</s0><s5>38</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Trouble neurologique</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Neurological disorder</s0><s5>39</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Trastorno neurológico</s0><s5>39</s5></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Encéphale pathologie</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Cerebral disorder</s0><s5>40</s5></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Encéfalo patología</s0><s5>40</s5></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Maladie dégénérative</s0><s5>41</s5></fC07><fC07 i1="05" i2="X" l="ENG"><s0>Degenerative disease</s0><s5>41</s5></fC07><fC07 i1="05" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0><s5>41</s5></fC07><fC07 i1="06" i2="X" l="FRE"><s0>Système nerveux central pathologie</s0><s5>42</s5></fC07><fC07 i1="06" i2="X" l="ENG"><s0>Central nervous system disease</s0><s5>42</s5></fC07><fC07 i1="06" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0><s5>42</s5></fC07><fN21><s1>085</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard><server><NO>PASCAL 07-0133240 INIST</NO><ET>Sarizotan as a treatment for dyskinesias in Parkinson's disease : A double-blind placebo-controlled trial</ET><AU>GOETZ (Christopher G.); DAMIER (Philippe); HICKING (Christine); LASKA (Eugene); MÜLLER (Thomas); OLANOW (C. Warren); RASCOL (Olivier); RUSS (Hermann)</AU><AF>Rush University Medical Center/Chicago, Illinois/Etats-Unis (1 aut.); Hôpital Guillaume et Rend Laennec/Nantes/France (2 aut.); Merck KGaA/Darmstadt/Allemagne (3 aut., 8 aut.); New York University School of Medicine, New York, and Nathan Kline Institute/Orangeburg, New York/Etats-Unis (4 aut.); Ruhr University/Bochum/Allemagne (5 aut.); Mount Sinai School of Medicine/New York, New York/Etats-Unis (6 aut.); Toulouse University Hospital/Toulouse/France (7 aut.)</AF><DT>Publication en série; Niveau analytique</DT><SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2007; Vol. 22; No. 2; Pp. 179-186; Bibl. 15 ref.</SO><LA>Anglais</LA><EA>The objective of this study is to conduct a dose-finding study of sarizotan in Parkinson's disease (PD) patients with dyskinesia to identify a safe dose and to identify a sensitive dyskinesia rating measure. Sarizotan is a novel compound with full 5-HT<sub>1A</sub> agonist properties and additional high affinity for D<sub>3</sub> and D<sub>4</sub> receptors. An open label study documented improvements in PD patients with levodopa-induced dyskinesia. There is no precedent for study designs or outcome measures in pivotal trials of antidyskinesia therapies. The approach used here was a multicenter, randomized, placebo-controlled, double-blind, parallel study. Included were PD patients optimized to levodopa and dopaminergic drugs with moderately disabling dyskinesias present greater than or equal to 25% of the waking day. Interventions included sarizotan 2, 4, or 10 mg/day or matching placebo, given in two doses. There were two outcome measures: the primary measure was change from baseline in diary-based on time without dyskinesia; the secondary measures were change from baseline in scores on the Abnormal Involuntary Movement Scale (AIMS), the composite score of Unified Parkinson's Disease Rating Scale (UPDRS) Items 32+33 (dyskinesia duration and disability) and total UPDRS. A total of 398 subjects were randomized, with 381 included in the intention-to-treat population. No significant changes occurred on sarizotan compared to placebo on any diary-based measure of dyskinesia or the AIMS score. The composite score of UPDRS Items 32+33 was significantly improved with 2 mg/day sarizotan, with a trend at 10 mg/day. Adverse events were not significantly different in sarizotan-and placebo-treated patients, but off time significantly increased with sarizotan 10 mg/day. Sarizotan 2 mg/day is a safe agent in PD patients with dyskinesia. To test its role in abating dyskinesia, future studies should focus on this dose and will use the composite score of UPDRS Items 32+33 as the primary outcome.</EA><CC>002B17; 002B17G; 002B02U01</CC><FD>Système nerveux pathologie; Dyskinésie; Parkinson maladie; Sarizotan; Traitement; Placebo; Essai clinique</FD><FG>Extrapyramidal syndrome; Mouvement involontaire; Trouble neurologique; Encéphale pathologie; Maladie dégénérative; Système nerveux central pathologie</FG><ED>Nervous system diseases; Dyskinesia; Parkinson disease; Sarizotan; Treatment; Placebo; Clinical trial</ED><EG>Extrapyramidal syndrome; Involuntary movement; Neurological disorder; Cerebral disorder; Degenerative disease; Central nervous system disease</EG><SD>Sistema nervioso patología; Disquinesia; Parkinson enfermedad; Sarizotán; Tratamiento; Placebo; Ensayo clínico</SD><LO>INIST-20953.354000145528070050</LO><ID>07-0133240</ID></server></inist></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Santé/explor/MovDisordV3/Data/PascalFrancis/Corpus
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 001812 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/PascalFrancis/Corpus/biblio.hfd -nk 001812 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Santé
|area= MovDisordV3
|flux= PascalFrancis
|étape= Corpus
|type= RBID
|clé= Pascal:07-0133240
|texte= Sarizotan as a treatment for dyskinesias in Parkinson's disease : A double-blind placebo-controlled trial
}}
| This area was generated with Dilib version V0.6.23. |  |