Orodispersible sublingual piribedil to abort OFF episodes: A single dose placebo‐controlled, randomized, double‐blind, cross‐over study
Identifieur interne : 001F73 ( Main/Merge ); précédent : 001F72; suivant : 001F74Orodispersible sublingual piribedil to abort OFF episodes: A single dose placebo‐controlled, randomized, double‐blind, cross‐over study
Auteurs : Olivier Rascol [France] ; Jean-Philippe Azulay [France] ; Olivier Blin [France] ; Anne-Marie Bonnet [France] ; Christine Brefel-Courbon [France] ; Pierre Césaro [France] ; Philippe Damier [France] ; Bérengère Debilly [France] ; Frank Durif [France] ; Monique Galitzky [France] ; Jean-Marie Grouin [France] ; Sylvie Pennaforte [France] ; Gabriel Villafane [France] ; Sadek Yaici [France] ; Yves Agid [France]Source :
- Movement Disorders [ 0885-3185 ] ; 2010-02-15.
Descripteurs français
- Wicri :
- geographic : France.
English descriptors
- KwdEn :
- Administration, Sublingual, Antiparkinson Agents (administration & dosage), Apomorphine (administration & dosage), Cross-Over Studies, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Routes, France, Humans, Logistic Models, Parkinson Disease (drug therapy), Parkinson's disease, Piribedil (administration & dosage), Proportional Hazards Models, S90049, Severity of Illness Index, apomorphine, dopamine agonist, motor fluctuations, piribedil.
- MESH :
- chemical , administration & dosage : Antiparkinson Agents, Apomorphine, Piribedil.
- geographic : France.
- drug therapy : Parkinson Disease.
- Administration, Sublingual, Cross-Over Studies, Dose-Response Relationship, Drug, Double-Blind Method, Drug Administration Routes, Humans, Logistic Models, Proportional Hazards Models, Severity of Illness Index.
Abstract
S90049, a novel sublingual formulation of the non‐ergoline D2‐D3 agonist piribedil, has a pharmacokinetic profile promising to provide rapid relief on motor signs in Parkinson's disease (PD). We assessed the efficacy and safety of S90049 in aborting OFF episodes responding to subcutaneous apomorphine in PD patients with motor fluctuations. This was a single‐dose double‐blind double‐placebo 3 × 3 cross‐over study. Optimal tested doses were determined during a previous open‐label titration phase (S90049 median dose: 60 mg, apomorphine: 5 mg). Primary endpoint was the maximal change versus baseline in UPDRS motor score (ΔUPDRS III) assessed after drug administration following an overnight withdrawal of antiparkinsonian medications. Thirty patients (age: 60 ± 8 years, PD duration: 12 ± 6 years, UPDRS III OFF: 37 ± 15) participated. S90049 wassuperior to placebo on ΔUPDRS III (−13 ± 12 versus −7 ± 9 respectively; estimated difference −5.2, 95% Confidence Interval (CI)[−10.4;0.05], P = 0.05). This was also true for secondary outcomes: number of patients switching from OFF to ON (17 on S90049 vs. 8 on placebo, P = 0.03), time to turn ON (P = 0.013) and duration of the ON phase (P = 0.03). In the 17 patients who switched ON on S90049, ΔUPDRS III was similar on S90049 (−21.2 ± 10.1) and apomorphine (−23.6 ± 14.1) (estimated difference: 4.0 95% CI [−2.9;10.9]). S90049 was well tolerated: no serious or unexpected adverse event occurred. A single dose of up to 60 mg of S90049 given sublingually was superior to placebo in improving UPDRS III and aborting a practical OFF in patients with advanced PD. Testing greater doses might improve response rate. © 2009 Movement Disorder Society
Url:
DOI: 10.1002/mds.22922
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type="city">Marseille</settlement></placeName></affiliation></author><author><name sortKey="Bonnet, Anne Arie" sort="Bonnet, Anne Arie" uniqKey="Bonnet A" first="Anne-Marie" last="Bonnet">Anne-Marie Bonnet</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Centre d'Investigation Clinique, Fédération des maladies du Système Nerveux, INSERM U 679, CHU Pitié‐Salpétrière, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Brefel Ourbon, Christine" sort="Brefel Ourbon, Christine" uniqKey="Brefel Ourbon C" first="Christine" last="Brefel-Courbon">Christine Brefel-Courbon</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Departments of Clinical Pharmacology and Neurosciences, INSERM Clinical Investigation Center CIC‐9302 and UMR‐825, CHU Toulouse‐Purpan and University Paul Sabatier, Toulouse</wicri:regionArea><placeName><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Cesaro, Pierre" sort="Cesaro, Pierre" uniqKey="Cesaro P" first="Pierre" last="Césaro">Pierre Césaro</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Neurosciences, INSERM U 841, CHU Henri Mondor, Créteil 94000</wicri:regionArea><placeName><region type="region" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Damier, Philippe" sort="Damier, Philippe" uniqKey="Damier P" first="Philippe" last="Damier">Philippe Damier</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>INSERM, Clinical Investigation Center CIC, and Clinique Neurologique, CHU Nantes, Nantes</wicri:regionArea><placeName><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Debilly, Berengere" sort="Debilly, Berengere" uniqKey="Debilly B" first="Bérengère" last="Debilly">Bérengère Debilly</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Service de Neurologie, Hôpital Gabriel Montpied, CHU Clermont‐Ferrand, Faculty of Medecine, University of Clermont, 1, EA 3845, Clermont‐Ferrand</wicri:regionArea><wicri:noRegion>Clermont‐Ferrand</wicri:noRegion><wicri:noRegion>Clermont‐Ferrand</wicri:noRegion></affiliation></author><author><name sortKey="Durif, Frank" sort="Durif, Frank" uniqKey="Durif F" first="Frank" last="Durif">Frank Durif</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Service de Neurologie, Hôpital Gabriel Montpied, CHU Clermont‐Ferrand, Faculty of Medecine, University of Clermont, 1, EA 3845, Clermont‐Ferrand</wicri:regionArea><wicri:noRegion>Clermont‐Ferrand</wicri:noRegion><wicri:noRegion>Clermont‐Ferrand</wicri:noRegion></affiliation></author><author><name sortKey="Galitzky, Monique" sort="Galitzky, Monique" uniqKey="Galitzky M" first="Monique" last="Galitzky">Monique Galitzky</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Departments of Clinical Pharmacology and Neurosciences, INSERM Clinical Investigation Center CIC‐9302 and UMR‐825, CHU Toulouse‐Purpan and University Paul Sabatier, Toulouse</wicri:regionArea><placeName><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Grouin, Jean Arie" sort="Grouin, Jean Arie" uniqKey="Grouin J" first="Jean-Marie" last="Grouin">Jean-Marie Grouin</name><affiliation wicri:level="4"><country xml:lang="fr">France</country><wicri:regionArea>Laboratoire de Biostatistiques, INSERM U 657, Université de Rouen, Rouen</wicri:regionArea><placeName><settlement type="city">Rouen</settlement></placeName><orgName type="university">Université de Rouen</orgName><placeName><settlement type="city">Rouen</settlement><region type="region" nuts="2">Région Bourgogne</region></placeName></affiliation></author><author><name sortKey="Pennaforte, Sylvie" sort="Pennaforte, Sylvie" uniqKey="Pennaforte S" first="Sylvie" last="Pennaforte">Sylvie Pennaforte</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Institut de Recherches Internationales Servier, Courbevoie</wicri:regionArea><wicri:noRegion>Courbevoie</wicri:noRegion><wicri:noRegion>Courbevoie</wicri:noRegion></affiliation></author><author><name sortKey="Villafane, Gabriel" sort="Villafane, Gabriel" uniqKey="Villafane G" first="Gabriel" last="Villafane">Gabriel Villafane</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Neurosciences, INSERM U 841, CHU Henri Mondor, Créteil 94000</wicri:regionArea><placeName><region type="region" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Yaici, Sadek" sort="Yaici, Sadek" uniqKey="Yaici S" first="Sadek" last="Yaici">Sadek Yaici</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Centre d'Investigation Clinique, Fédération des maladies du Système Nerveux, INSERM U 679, CHU Pitié‐Salpétrière, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Agid, Yves" sort="Agid, Yves" uniqKey="Agid Y" first="Yves" last="Agid">Yves Agid</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Centre d'Investigation Clinique, Fédération des maladies du Système Nerveux, INSERM U 679, CHU Pitié‐Salpétrière, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement></placeName><placeName><settlement type="city">Paris</settlement><region type="region" nuts="2">Île-de-France</region></placeName><orgName type="hospital" n="4">Hôpital de la Salpêtrière</orgName></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2010-02-15">2010-02-15</date><biblScope unit="vol">25</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="368">368</biblScope><biblScope unit="page" to="376">376</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">336E94F27649D97517D84497998FD3E90304F4EF</idno><idno type="DOI">10.1002/mds.22922</idno><idno type="ArticleID">MDS22922</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Sublingual</term><term>Antiparkinson Agents (administration & dosage)</term><term>Apomorphine (administration & dosage)</term><term>Cross-Over Studies</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Routes</term><term>France</term><term>Humans</term><term>Logistic Models</term><term>Parkinson Disease (drug therapy)</term><term>Parkinson's disease</term><term>Piribedil (administration & dosage)</term><term>Proportional Hazards Models</term><term>S90049</term><term>Severity of Illness Index</term><term>apomorphine</term><term>dopamine agonist</term><term>motor fluctuations</term><term>piribedil</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term><term>Apomorphine</term><term>Piribedil</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>France</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Sublingual</term><term>Cross-Over Studies</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Routes</term><term>Humans</term><term>Logistic Models</term><term>Proportional Hazards Models</term><term>Severity of Illness Index</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>France</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">S90049, a novel sublingual formulation of the non‐ergoline D2‐D3 agonist piribedil, has a pharmacokinetic profile promising to provide rapid relief on motor signs in Parkinson's disease (PD). We assessed the efficacy and safety of S90049 in aborting OFF episodes responding to subcutaneous apomorphine in PD patients with motor fluctuations. This was a single‐dose double‐blind double‐placebo 3 × 3 cross‐over study. Optimal tested doses were determined during a previous open‐label titration phase (S90049 median dose: 60 mg, apomorphine: 5 mg). Primary endpoint was the maximal change versus baseline in UPDRS motor score (ΔUPDRS III) assessed after drug administration following an overnight withdrawal of antiparkinsonian medications. Thirty patients (age: 60 ± 8 years, PD duration: 12 ± 6 years, UPDRS III OFF: 37 ± 15) participated. S90049 wassuperior to placebo on ΔUPDRS III (−13 ± 12 versus −7 ± 9 respectively; estimated difference −5.2, 95% Confidence Interval (CI)[−10.4;0.05], P = 0.05). This was also true for secondary outcomes: number of patients switching from OFF to ON (17 on S90049 vs. 8 on placebo, P = 0.03), time to turn ON (P = 0.013) and duration of the ON phase (P = 0.03). In the 17 patients who switched ON on S90049, ΔUPDRS III was similar on S90049 (−21.2 ± 10.1) and apomorphine (−23.6 ± 14.1) (estimated difference: 4.0 95% CI [−2.9;10.9]). S90049 was well tolerated: no serious or unexpected adverse event occurred. A single dose of up to 60 mg of S90049 given sublingually was superior to placebo in improving UPDRS III and aborting a practical OFF in patients with advanced PD. Testing greater doses might improve response rate. © 2009 Movement Disorder Society</div></front></TEI><double doi="10.1002/mds.22922"><ISTEX><TEI wicri:istexFullTextTei="biblStruct"><teiHeader><fileDesc><titleStmt><title xml:lang="en">Orodispersible sublingual piribedil to abort OFF episodes: A single dose placebo‐controlled, randomized, double‐blind, cross‐over study</title><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation><country>France</country><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation></author><author><name sortKey="Azulay, Jean Hilippe" sort="Azulay, Jean Hilippe" uniqKey="Azulay J" first="Jean-Philippe" last="Azulay">Jean-Philippe Azulay</name></author><author><name sortKey="Blin, Olivier" sort="Blin, Olivier" uniqKey="Blin O" first="Olivier" last="Blin">Olivier Blin</name></author><author><name sortKey="Bonnet, Anne Arie" sort="Bonnet, Anne Arie" uniqKey="Bonnet A" first="Anne-Marie" last="Bonnet">Anne-Marie Bonnet</name></author><author><name sortKey="Brefel Ourbon, Christine" sort="Brefel Ourbon, Christine" uniqKey="Brefel Ourbon C" first="Christine" last="Brefel-Courbon">Christine Brefel-Courbon</name></author><author><name sortKey="Cesaro, Pierre" sort="Cesaro, Pierre" uniqKey="Cesaro P" first="Pierre" last="Césaro">Pierre Césaro</name></author><author><name sortKey="Damier, Philippe" sort="Damier, Philippe" uniqKey="Damier P" first="Philippe" last="Damier">Philippe Damier</name></author><author><name sortKey="Debilly, Berengere" sort="Debilly, Berengere" uniqKey="Debilly B" first="Bérengère" last="Debilly">Bérengère Debilly</name></author><author><name sortKey="Durif, Frank" sort="Durif, Frank" uniqKey="Durif F" first="Frank" last="Durif">Frank Durif</name></author><author><name sortKey="Galitzky, Monique" sort="Galitzky, Monique" uniqKey="Galitzky M" first="Monique" last="Galitzky">Monique Galitzky</name></author><author><name sortKey="Grouin, Jean Arie" sort="Grouin, Jean Arie" uniqKey="Grouin J" first="Jean-Marie" last="Grouin">Jean-Marie Grouin</name></author><author><name sortKey="Pennaforte, Sylvie" sort="Pennaforte, Sylvie" uniqKey="Pennaforte S" first="Sylvie" last="Pennaforte">Sylvie Pennaforte</name></author><author><name sortKey="Villafane, Gabriel" sort="Villafane, Gabriel" uniqKey="Villafane G" first="Gabriel" last="Villafane">Gabriel Villafane</name></author><author><name sortKey="Yaici, Sadek" sort="Yaici, Sadek" uniqKey="Yaici S" first="Sadek" last="Yaici">Sadek Yaici</name></author><author><name sortKey="Agid, Yves" sort="Agid, Yves" uniqKey="Agid Y" first="Yves" last="Agid">Yves Agid</name><affiliation><country>France</country><placeName><settlement type="city">Paris</settlement><region type="region" nuts="2">Île-de-France</region></placeName><orgName type="hospital" n="4">Hôpital de la Salpêtrière</orgName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">ISTEX</idno><idno type="RBID">ISTEX:336E94F27649D97517D84497998FD3E90304F4EF</idno><date when="2010" year="2010">2010</date><idno type="doi">10.1002/mds.22922</idno><idno type="url">https://api.istex.fr/document/336E94F27649D97517D84497998FD3E90304F4EF/fulltext/pdf</idno><idno type="wicri:Area/Istex/Corpus">000517</idno><idno type="wicri:Area/Istex/Curation">000517</idno><idno type="wicri:Area/Istex/Checkpoint">000816</idno><idno type="wicri:doubleKey">0885-3185:2010:Rascol O:orodispersible:sublingual:piribedil</idno></publicationStmt><sourceDesc><biblStruct><analytic><title level="a" type="main" xml:lang="en">Orodispersible sublingual piribedil to abort OFF episodes: A single dose placebo‐controlled, randomized, double‐blind, cross‐over study</title><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Departments of Clinical Pharmacology and Neurosciences, INSERM Clinical Investigation Center CIC‐9302 and UMR‐825, CHU Toulouse‐Purpan and University Paul Sabatier, Toulouse</wicri:regionArea><placeName><settlement type="city">Toulouse</settlement></placeName><placeName><settlement type="city">Toulouse</settlement><region type="region" nuts="2">Midi-Pyrénées</region></placeName><orgName type="university" n="3">Université Toulouse III - Paul Sabatier</orgName><orgName type="institution" wicri:auto="newGroup">Université de Toulouse</orgName></affiliation></author><author><name sortKey="Azulay, Jean Hilippe" sort="Azulay, Jean Hilippe" uniqKey="Azulay J" first="Jean-Philippe" last="Azulay">Jean-Philippe Azulay</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Service de Neurologie et Pathologie du Mouvement, Pôle Neurosciences cliniques, CHU Timone, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation></author><author><name sortKey="Blin, Olivier" sort="Blin, Olivier" uniqKey="Blin O" first="Olivier" last="Blin">Olivier Blin</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Clinical Investigation Centre (CIC‐UPCET) and Department of Clinical Pharmacology, UMR‐CNRS 6193 Institute of Cognitive Neurosciences, CHU Timone, Marseille</wicri:regionArea><placeName><settlement type="city">Marseille</settlement></placeName></affiliation></author><author><name sortKey="Bonnet, Anne Arie" sort="Bonnet, Anne Arie" uniqKey="Bonnet A" first="Anne-Marie" last="Bonnet">Anne-Marie Bonnet</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Centre d'Investigation Clinique, Fédération des maladies du Système Nerveux, INSERM U 679, CHU Pitié‐Salpétrière, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Brefel Ourbon, Christine" sort="Brefel Ourbon, Christine" uniqKey="Brefel Ourbon C" first="Christine" last="Brefel-Courbon">Christine Brefel-Courbon</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Departments of Clinical Pharmacology and Neurosciences, INSERM Clinical Investigation Center CIC‐9302 and UMR‐825, CHU Toulouse‐Purpan and University Paul Sabatier, Toulouse</wicri:regionArea><placeName><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Cesaro, Pierre" sort="Cesaro, Pierre" uniqKey="Cesaro P" first="Pierre" last="Césaro">Pierre Césaro</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Neurosciences, INSERM U 841, CHU Henri Mondor, Créteil 94000</wicri:regionArea><placeName><region type="region" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Damier, Philippe" sort="Damier, Philippe" uniqKey="Damier P" first="Philippe" last="Damier">Philippe Damier</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>INSERM, Clinical Investigation Center CIC, and Clinique Neurologique, CHU Nantes, Nantes</wicri:regionArea><placeName><settlement type="city">Nantes</settlement></placeName></affiliation></author><author><name sortKey="Debilly, Berengere" sort="Debilly, Berengere" uniqKey="Debilly B" first="Bérengère" last="Debilly">Bérengère Debilly</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Service de Neurologie, Hôpital Gabriel Montpied, CHU Clermont‐Ferrand, Faculty of Medecine, University of Clermont, 1, EA 3845, Clermont‐Ferrand</wicri:regionArea><wicri:noRegion>Clermont‐Ferrand</wicri:noRegion><wicri:noRegion>Clermont‐Ferrand</wicri:noRegion></affiliation></author><author><name sortKey="Durif, Frank" sort="Durif, Frank" uniqKey="Durif F" first="Frank" last="Durif">Frank Durif</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Service de Neurologie, Hôpital Gabriel Montpied, CHU Clermont‐Ferrand, Faculty of Medecine, University of Clermont, 1, EA 3845, Clermont‐Ferrand</wicri:regionArea><wicri:noRegion>Clermont‐Ferrand</wicri:noRegion><wicri:noRegion>Clermont‐Ferrand</wicri:noRegion></affiliation></author><author><name sortKey="Galitzky, Monique" sort="Galitzky, Monique" uniqKey="Galitzky M" first="Monique" last="Galitzky">Monique Galitzky</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Departments of Clinical Pharmacology and Neurosciences, INSERM Clinical Investigation Center CIC‐9302 and UMR‐825, CHU Toulouse‐Purpan and University Paul Sabatier, Toulouse</wicri:regionArea><placeName><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Grouin, Jean Arie" sort="Grouin, Jean Arie" uniqKey="Grouin J" first="Jean-Marie" last="Grouin">Jean-Marie Grouin</name><affiliation wicri:level="4"><country xml:lang="fr">France</country><wicri:regionArea>Laboratoire de Biostatistiques, INSERM U 657, Université de Rouen, Rouen</wicri:regionArea><placeName><settlement type="city">Rouen</settlement></placeName><orgName type="university">Université de Rouen</orgName><placeName><settlement type="city">Rouen</settlement><region type="region" nuts="2">Région Bourgogne</region></placeName></affiliation></author><author><name sortKey="Pennaforte, Sylvie" sort="Pennaforte, Sylvie" uniqKey="Pennaforte S" first="Sylvie" last="Pennaforte">Sylvie Pennaforte</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Institut de Recherches Internationales Servier, Courbevoie</wicri:regionArea><wicri:noRegion>Courbevoie</wicri:noRegion><wicri:noRegion>Courbevoie</wicri:noRegion></affiliation></author><author><name sortKey="Villafane, Gabriel" sort="Villafane, Gabriel" uniqKey="Villafane G" first="Gabriel" last="Villafane">Gabriel Villafane</name><affiliation wicri:level="3"><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Neurosciences, INSERM U 841, CHU Henri Mondor, Créteil 94000</wicri:regionArea><placeName><region type="region" nuts="2">Île-de-France</region></placeName></affiliation></author><author><name sortKey="Yaici, Sadek" sort="Yaici, Sadek" uniqKey="Yaici S" first="Sadek" last="Yaici">Sadek Yaici</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Centre d'Investigation Clinique, Fédération des maladies du Système Nerveux, INSERM U 679, CHU Pitié‐Salpétrière, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement></placeName></affiliation></author><author><name sortKey="Agid, Yves" sort="Agid, Yves" uniqKey="Agid Y" first="Yves" last="Agid">Yves Agid</name><affiliation wicri:level="1"><country xml:lang="fr">France</country><wicri:regionArea>Centre d'Investigation Clinique, Fédération des maladies du Système Nerveux, INSERM U 679, CHU Pitié‐Salpétrière, Paris</wicri:regionArea><placeName><settlement type="city">Paris</settlement></placeName><placeName><settlement type="city">Paris</settlement><region type="region" nuts="2">Île-de-France</region></placeName><orgName type="hospital" n="4">Hôpital de la Salpêtrière</orgName></affiliation></author></analytic><monogr></monogr><series><title level="j">Movement Disorders</title><title level="j" type="abbrev">Mov. Disord.</title><idno type="ISSN">0885-3185</idno><idno type="eISSN">1531-8257</idno><imprint><publisher>Wiley Subscription Services, Inc., A Wiley Company</publisher><pubPlace>Hoboken</pubPlace><date type="published" when="2010-02-15">2010-02-15</date><biblScope unit="vol">25</biblScope><biblScope unit="issue">3</biblScope><biblScope unit="page" from="368">368</biblScope><biblScope unit="page" to="376">376</biblScope></imprint><idno type="ISSN">0885-3185</idno></series><idno type="istex">336E94F27649D97517D84497998FD3E90304F4EF</idno><idno type="DOI">10.1002/mds.22922</idno><idno type="ArticleID">MDS22922</idno></biblStruct></sourceDesc><seriesStmt><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Parkinson's disease</term><term>S90049</term><term>apomorphine</term><term>dopamine agonist</term><term>motor fluctuations</term><term>piribedil</term></keywords></textClass><langUsage><language ident="en">en</language></langUsage></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">S90049, a novel sublingual formulation of the non‐ergoline D2‐D3 agonist piribedil, has a pharmacokinetic profile promising to provide rapid relief on motor signs in Parkinson's disease (PD). We assessed the efficacy and safety of S90049 in aborting OFF episodes responding to subcutaneous apomorphine in PD patients with motor fluctuations. This was a single‐dose double‐blind double‐placebo 3 × 3 cross‐over study. Optimal tested doses were determined during a previous open‐label titration phase (S90049 median dose: 60 mg, apomorphine: 5 mg). Primary endpoint was the maximal change versus baseline in UPDRS motor score (ΔUPDRS III) assessed after drug administration following an overnight withdrawal of antiparkinsonian medications. Thirty patients (age: 60 ± 8 years, PD duration: 12 ± 6 years, UPDRS III OFF: 37 ± 15) participated. S90049 wassuperior to placebo on ΔUPDRS III (−13 ± 12 versus −7 ± 9 respectively; estimated difference −5.2, 95% Confidence Interval (CI)[−10.4;0.05], P = 0.05). This was also true for secondary outcomes: number of patients switching from OFF to ON (17 on S90049 vs. 8 on placebo, P = 0.03), time to turn ON (P = 0.013) and duration of the ON phase (P = 0.03). In the 17 patients who switched ON on S90049, ΔUPDRS III was similar on S90049 (−21.2 ± 10.1) and apomorphine (−23.6 ± 14.1) (estimated difference: 4.0 95% CI [−2.9;10.9]). S90049 was well tolerated: no serious or unexpected adverse event occurred. A single dose of up to 60 mg of S90049 given sublingually was superior to placebo in improving UPDRS III and aborting a practical OFF in patients with advanced PD. Testing greater doses might improve response rate. © 2009 Movement Disorder Society</div></front></TEI></ISTEX><PubMed><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Orodispersible sublingual piribedil to abort OFF episodes: a single dose placebo-controlled, randomized, double-blind, cross-over study.</title><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Pharmacology, INSERM Clinical Investigation Center CIC-9302 and UMR-825, CHU Toulouse-Purpan and University Paul Sabatier, Toulouse, France. rascol@cict.fr</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Pharmacology, INSERM Clinical Investigation Center CIC-9302 and UMR-825, CHU Toulouse-Purpan and University Paul Sabatier, Toulouse</wicri:regionArea><placeName><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Azulay, Jean Philippe" sort="Azulay, Jean Philippe" uniqKey="Azulay J" first="Jean-Philippe" last="Azulay">Jean-Philippe Azulay</name></author><author><name sortKey="Blin, Olivier" sort="Blin, Olivier" uniqKey="Blin O" first="Olivier" last="Blin">Olivier Blin</name></author><author><name sortKey="Bonnet, Anne Marie" sort="Bonnet, Anne Marie" uniqKey="Bonnet A" first="Anne-Marie" last="Bonnet">Anne-Marie Bonnet</name></author><author><name sortKey="Brefel Courbon, Christine" sort="Brefel Courbon, Christine" uniqKey="Brefel Courbon C" first="Christine" last="Brefel-Courbon">Christine Brefel-Courbon</name></author><author><name sortKey="Cesaro, Pierre" sort="Cesaro, Pierre" uniqKey="Cesaro P" first="Pierre" last="Césaro">Pierre Césaro</name></author><author><name sortKey="Damier, Philippe" sort="Damier, Philippe" uniqKey="Damier P" first="Philippe" last="Damier">Philippe Damier</name></author><author><name sortKey="Debilly, Berengere" sort="Debilly, Berengere" uniqKey="Debilly B" first="Bérengère" last="Debilly">Bérengère Debilly</name></author><author><name sortKey="Durif, Frank" sort="Durif, Frank" uniqKey="Durif F" first="Frank" last="Durif">Frank Durif</name></author><author><name sortKey="Galitzky, Monique" sort="Galitzky, Monique" uniqKey="Galitzky M" first="Monique" last="Galitzky">Monique Galitzky</name></author><author><name sortKey="Grouin, Jean Marie" sort="Grouin, Jean Marie" uniqKey="Grouin J" first="Jean-Marie" last="Grouin">Jean-Marie Grouin</name></author><author><name sortKey="Pennaforte, Sylvie" sort="Pennaforte, Sylvie" uniqKey="Pennaforte S" first="Sylvie" last="Pennaforte">Sylvie Pennaforte</name></author><author><name sortKey="Villafane, Gabriel" sort="Villafane, Gabriel" uniqKey="Villafane G" first="Gabriel" last="Villafane">Gabriel Villafane</name></author><author><name sortKey="Yaici, Sadek" sort="Yaici, Sadek" uniqKey="Yaici S" first="Sadek" last="Yaici">Sadek Yaici</name></author><author><name sortKey="Agid, Yves" sort="Agid, Yves" uniqKey="Agid Y" first="Yves" last="Agid">Yves Agid</name><affiliation><country>France</country><placeName><settlement type="city">Paris</settlement><region type="region" nuts="2">Île-de-France</region></placeName><orgName type="hospital" n="4">Hôpital de la Salpêtrière</orgName></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2010">2010</date><idno type="doi">10.1002/mds.22922</idno><idno type="RBID">pubmed:20063435</idno><idno type="pmid">20063435</idno><idno type="wicri:Area/PubMed/Corpus">001A30</idno><idno type="wicri:Area/PubMed/Curation">001A30</idno><idno type="wicri:Area/PubMed/Checkpoint">001734</idno><idno type="wicri:Area/Ncbi/Merge">002972</idno><idno type="wicri:Area/Ncbi/Curation">002972</idno><idno type="wicri:Area/Ncbi/Checkpoint">002972</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en">Orodispersible sublingual piribedil to abort OFF episodes: a single dose placebo-controlled, randomized, double-blind, cross-over study.</title><author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name><affiliation wicri:level="1"><nlm:affiliation>Department of Clinical Pharmacology, INSERM Clinical Investigation Center CIC-9302 and UMR-825, CHU Toulouse-Purpan and University Paul Sabatier, Toulouse, France. rascol@cict.fr</nlm:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Pharmacology, INSERM Clinical Investigation Center CIC-9302 and UMR-825, CHU Toulouse-Purpan and University Paul Sabatier, Toulouse</wicri:regionArea><placeName><settlement type="city">Toulouse</settlement></placeName></affiliation></author><author><name sortKey="Azulay, Jean Philippe" sort="Azulay, Jean Philippe" uniqKey="Azulay J" first="Jean-Philippe" last="Azulay">Jean-Philippe Azulay</name></author><author><name sortKey="Blin, Olivier" sort="Blin, Olivier" uniqKey="Blin O" first="Olivier" last="Blin">Olivier Blin</name></author><author><name sortKey="Bonnet, Anne Marie" sort="Bonnet, Anne Marie" uniqKey="Bonnet A" first="Anne-Marie" last="Bonnet">Anne-Marie Bonnet</name></author><author><name sortKey="Brefel Courbon, Christine" sort="Brefel Courbon, Christine" uniqKey="Brefel Courbon C" first="Christine" last="Brefel-Courbon">Christine Brefel-Courbon</name></author><author><name sortKey="Cesaro, Pierre" sort="Cesaro, Pierre" uniqKey="Cesaro P" first="Pierre" last="Césaro">Pierre Césaro</name></author><author><name sortKey="Damier, Philippe" sort="Damier, Philippe" uniqKey="Damier P" first="Philippe" last="Damier">Philippe Damier</name></author><author><name sortKey="Debilly, Berengere" sort="Debilly, Berengere" uniqKey="Debilly B" first="Bérengère" last="Debilly">Bérengère Debilly</name></author><author><name sortKey="Durif, Frank" sort="Durif, Frank" uniqKey="Durif F" first="Frank" last="Durif">Frank Durif</name></author><author><name sortKey="Galitzky, Monique" sort="Galitzky, Monique" uniqKey="Galitzky M" first="Monique" last="Galitzky">Monique Galitzky</name></author><author><name sortKey="Grouin, Jean Marie" sort="Grouin, Jean Marie" uniqKey="Grouin J" first="Jean-Marie" last="Grouin">Jean-Marie Grouin</name></author><author><name sortKey="Pennaforte, Sylvie" sort="Pennaforte, Sylvie" uniqKey="Pennaforte S" first="Sylvie" last="Pennaforte">Sylvie Pennaforte</name></author><author><name sortKey="Villafane, Gabriel" sort="Villafane, Gabriel" uniqKey="Villafane G" first="Gabriel" last="Villafane">Gabriel Villafane</name></author><author><name sortKey="Yaici, Sadek" sort="Yaici, Sadek" uniqKey="Yaici S" first="Sadek" last="Yaici">Sadek Yaici</name></author><author><name sortKey="Agid, Yves" sort="Agid, Yves" uniqKey="Agid Y" first="Yves" last="Agid">Yves Agid</name><affiliation><country>France</country><placeName><settlement type="city">Paris</settlement><region type="region" nuts="2">Île-de-France</region></placeName><orgName type="hospital" n="4">Hôpital de la Salpêtrière</orgName></affiliation></author></analytic><series><title level="j">Movement disorders : official journal of the Movement Disorder Society</title><idno type="eISSN">1531-8257</idno><imprint><date when="2010" type="published">2010</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Administration, Sublingual</term><term>Antiparkinson Agents (administration & dosage)</term><term>Apomorphine (administration & dosage)</term><term>Cross-Over Studies</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Routes</term><term>France</term><term>Humans</term><term>Logistic Models</term><term>Parkinson Disease (drug therapy)</term><term>Piribedil (administration & dosage)</term><term>Proportional Hazards Models</term><term>Severity of Illness Index</term></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antiparkinson Agents</term><term>Apomorphine</term><term>Piribedil</term></keywords><keywords scheme="MESH" type="geographic" xml:lang="en"><term>France</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Parkinson Disease</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Administration, Sublingual</term><term>Cross-Over Studies</term><term>Dose-Response Relationship, Drug</term><term>Double-Blind Method</term><term>Drug Administration Routes</term><term>Humans</term><term>Logistic Models</term><term>Proportional Hazards Models</term><term>Severity of Illness Index</term></keywords><keywords scheme="Wicri" type="geographic" xml:lang="fr"><term>France</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">S90049, a novel sublingual formulation of the non-ergoline D(2)-D(3) agonist piribedil, has a pharmacokinetic profile promising to provide rapid relief on motor signs in Parkinson's disease (PD). We assessed the efficacy and safety of S90049 in aborting OFF episodes responding to subcutaneous apomorphine in PD patients with motor fluctuations. This was a single-dose double-blind double-placebo 3 x 3 cross-over study. Optimal tested doses were determined during a previous open-label titration phase (S90049 median dose: 60 mg, apomorphine: 5 mg). Primary endpoint was the maximal change versus baseline in UPDRS motor score (Delta UPDRS III) assessed after drug administration following an overnight withdrawal of antiparkinsonian medications. Thirty patients (age: 60 +/- 8 years, PD duration: 12 +/- 6 years, UPDRS III OFF: 37 +/- 15) participated. S90049 was superior to placebo on Delta UPDRS III (-13 +/- 12 versus -7 +/- 9 respectively; estimated difference -5.2, 95% Confidence Interval (CI)[-10.4;0.05], P = 0.05). This was also true for secondary outcomes: number of patients switching from OFF to ON (17 on S90049 vs. 8 on placebo, P = 0.03), time to turn ON (P = 0.013) and duration of the ON phase (P = 0.03). In the 17 patients who switched ON on S90049, Delta UPDRS III was similar on S90049 (-21.2 +/- 10.1) and apomorphine (-23.6 +/- 14.1) (estimated difference: 4.0 95% CI [-2.9;10.9]). S90049 was well tolerated: no serious or unexpected adverse event occurred. A single dose of up to 60 mg of S90049 given sublingually was superior to placebo in improving UPDRS III and aborting a practical OFF in patients with advanced PD. Testing greater doses might improve response rate.</div></front></TEI></PubMed></double></record>Pour manipuler ce document sous Unix (Dilib)
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