Orodispersible sublingual piribedil to abort OFF episodes: A single dose placebo‐controlled, randomized, double‐blind, cross‐over study
Identifieur interne : 000517 ( Istex/Curation ); précédent : 000516; suivant : 000518Orodispersible 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.
English descriptors
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
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DOI: 10.1002/mds.22922
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Courbevoie</wicri:regionArea></affiliation></author><author><name sortKey="Villafane, Gabriel" sort="Villafane, Gabriel" uniqKey="Villafane G" first="Gabriel" last="Villafane">Gabriel Villafane</name><affiliation wicri:level="1"><mods:affiliation>Department of Clinical Neurosciences, INSERM U 841, CHU Henri Mondor, Créteil 94000, France</mods:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Neurosciences, INSERM U 841, CHU Henri Mondor, Créteil 94000</wicri:regionArea></affiliation></author><author><name sortKey="Yaici, Sadek" sort="Yaici, Sadek" uniqKey="Yaici S" first="Sadek" last="Yaici">Sadek Yaici</name><affiliation wicri:level="1"><mods:affiliation>Centre d'Investigation Clinique, Fédération des maladies du Système Nerveux, INSERM U 679, CHU Pitié‐Salpétrière, Paris, France</mods:affiliation><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></affiliation></author><author><name sortKey="Agid, Yves" sort="Agid, Yves" uniqKey="Agid Y" first="Yves" last="Agid">Yves Agid</name><affiliation wicri:level="1"><mods:affiliation>Centre d'Investigation Clinique, Fédération des maladies du Système Nerveux, INSERM U 679, CHU Pitié‐Salpétrière, Paris, France</mods:affiliation><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></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></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"><mods:affiliation>Departments of Clinical Pharmacology and Neurosciences, INSERM Clinical Investigation Center CIC‐9302 and UMR‐825, CHU Toulouse‐Purpan and University Paul Sabatier, Toulouse, France</mods:affiliation><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></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"><mods:affiliation>Service de Neurologie et Pathologie du Mouvement, Pôle Neurosciences cliniques, CHU Timone, Marseille, France</mods:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Service de Neurologie et Pathologie du Mouvement, Pôle Neurosciences cliniques, CHU Timone, Marseille</wicri:regionArea></affiliation></author><author><name sortKey="Blin, Olivier" sort="Blin, Olivier" uniqKey="Blin O" first="Olivier" last="Blin">Olivier Blin</name><affiliation wicri:level="1"><mods:affiliation>Clinical Investigation Centre (CIC‐UPCET) and Department of Clinical Pharmacology, UMR‐CNRS 6193 Institute of Cognitive Neurosciences, CHU Timone, Marseille, France</mods:affiliation><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></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"><mods:affiliation>Centre d'Investigation Clinique, Fédération des maladies du Système Nerveux, INSERM U 679, CHU Pitié‐Salpétrière, Paris, France</mods:affiliation><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></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"><mods:affiliation>Departments of Clinical Pharmacology and Neurosciences, INSERM Clinical Investigation Center CIC‐9302 and UMR‐825, CHU Toulouse‐Purpan and University Paul Sabatier, Toulouse, France</mods:affiliation><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></affiliation></author><author><name sortKey="Cesaro, Pierre" sort="Cesaro, Pierre" uniqKey="Cesaro P" first="Pierre" last="Césaro">Pierre Césaro</name><affiliation wicri:level="1"><mods:affiliation>Department of Clinical Neurosciences, INSERM U 841, CHU Henri Mondor, Créteil 94000, France</mods:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Neurosciences, INSERM U 841, CHU Henri Mondor, Créteil 94000</wicri:regionArea></affiliation></author><author><name sortKey="Damier, Philippe" sort="Damier, Philippe" uniqKey="Damier P" first="Philippe" last="Damier">Philippe Damier</name><affiliation wicri:level="1"><mods:affiliation>INSERM, Clinical Investigation Center CIC, and Clinique Neurologique, CHU Nantes, Nantes, France</mods:affiliation><country xml:lang="fr">France</country><wicri:regionArea>INSERM, Clinical Investigation Center CIC, and Clinique Neurologique, CHU Nantes, Nantes</wicri:regionArea></affiliation></author><author><name sortKey="Debilly, Berengere" sort="Debilly, Berengere" uniqKey="Debilly B" first="Bérengère" last="Debilly">Bérengère Debilly</name><affiliation wicri:level="1"><mods:affiliation>Service de Neurologie, Hôpital Gabriel Montpied, CHU Clermont‐Ferrand, Faculty of Medecine, University of Clermont, 1, EA 3845, Clermont‐Ferrand, France</mods:affiliation><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></affiliation></author><author><name sortKey="Durif, Frank" sort="Durif, Frank" uniqKey="Durif F" first="Frank" last="Durif">Frank Durif</name><affiliation wicri:level="1"><mods:affiliation>Service de Neurologie, Hôpital Gabriel Montpied, CHU Clermont‐Ferrand, Faculty of Medecine, University of Clermont, 1, EA 3845, Clermont‐Ferrand, France</mods:affiliation><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></affiliation></author><author><name sortKey="Galitzky, Monique" sort="Galitzky, Monique" uniqKey="Galitzky M" first="Monique" last="Galitzky">Monique Galitzky</name><affiliation wicri:level="1"><mods:affiliation>Departments of Clinical Pharmacology and Neurosciences, INSERM Clinical Investigation Center CIC‐9302 and UMR‐825, CHU Toulouse‐Purpan and University Paul Sabatier, Toulouse, France</mods:affiliation><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></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="1"><mods:affiliation>Laboratoire de Biostatistiques, INSERM U 657, Université de Rouen, Rouen, France</mods:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Laboratoire de Biostatistiques, INSERM U 657, Université de Rouen, Rouen</wicri:regionArea></affiliation></author><author><name sortKey="Pennaforte, Sylvie" sort="Pennaforte, Sylvie" uniqKey="Pennaforte S" first="Sylvie" last="Pennaforte">Sylvie Pennaforte</name><affiliation wicri:level="1"><mods:affiliation>Institut de Recherches Internationales Servier, Courbevoie, France</mods:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Institut de Recherches Internationales Servier, Courbevoie</wicri:regionArea></affiliation></author><author><name sortKey="Villafane, Gabriel" sort="Villafane, Gabriel" uniqKey="Villafane G" first="Gabriel" last="Villafane">Gabriel Villafane</name><affiliation wicri:level="1"><mods:affiliation>Department of Clinical Neurosciences, INSERM U 841, CHU Henri Mondor, Créteil 94000, France</mods:affiliation><country xml:lang="fr">France</country><wicri:regionArea>Department of Clinical Neurosciences, INSERM U 841, CHU Henri Mondor, Créteil 94000</wicri:regionArea></affiliation></author><author><name sortKey="Yaici, Sadek" sort="Yaici, Sadek" uniqKey="Yaici S" first="Sadek" last="Yaici">Sadek Yaici</name><affiliation wicri:level="1"><mods:affiliation>Centre d'Investigation Clinique, Fédération des maladies du Système Nerveux, INSERM U 679, CHU Pitié‐Salpétrière, Paris, France</mods:affiliation><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></affiliation></author><author><name sortKey="Agid, Yves" sort="Agid, Yves" uniqKey="Agid Y" first="Yves" last="Agid">Yves Agid</name><affiliation wicri:level="1"><mods:affiliation>Centre d'Investigation Clinique, Fédération des maladies du Système Nerveux, INSERM U 679, CHU Pitié‐Salpétrière, Paris, France</mods:affiliation><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></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></record>Pour manipuler ce document sous Unix (Dilib)
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