ParkinsonFranceV1, PascalFrancis, Checkpoint, bibRecord, 000472

Orodispersible Sublingual Piribedil to Abort OFF Episodes: A Single Dose Placebo-Controlled, Randomized, Double-Blind, Cross-Over Study

Identifieur interne : 000472 ( PascalFrancis/Checkpoint ); précédent : 000471; suivant : 000473

Orodispersible 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 Cesaro [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.

RBID : Pascal:10-0161577

Descripteurs français

Pascal (Inist)
- Maladie de Parkinson, Pathologie du système nerveux, Piribédil, Dose unique, Placebo, Etude double insu, Fluctuation, Stimulant dopaminergique, Apomorphine.

English descriptors

KwdEn :
- Dopamine agonist, Double blind study, Fluctuations, Nervous system diseases, Parkinson disease, Piribedil, Placebo, Single dose.

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 was superior 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.

Affiliations:

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<author><name sortKey="Debilly, Berengere" sort="Debilly, Berengere" uniqKey="Debilly B" first="Bérengère" last="Debilly">Bérengère Debilly</name>
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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">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="3"><inist:fA14 i1="01"><s1>Departments of Clinical Pharmacology and Neurosciences, INSERM Clinical Investigation Center CIC-9302 and UMR-825, CHU Toulouse-Purpan and University Paul Sabatier</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Occitanie (région administrative)</region>
<region type="old region">Midi-Pyrénées</region>
<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>
<affiliation wicri:level="3"><inist:fA14 i1="02"><s1>Service de Neurologie et Pathologie du Mouvement, Pôle Neurosciences cliniques, CHU Timone</s1>
<s2>Marseille</s2>
<s3>FRA</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Provence-Alpes-Côte d'Azur</region>
<region type="old region">Provence-Alpes-Côte d'Azur</region>
<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="3"><inist:fA14 i1="03"><s1>Clinical Investigation Centre (CIC-UPCET) and Department of Clinical Pharmacology, UMR-CNRS 6193 Institute of Cognitive Neurosciences, CHU Timone</s1>
<s2>Marseille</s2>
<s3>FRA</s3>
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</inist:fA14>
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<placeName><region type="region">Provence-Alpes-Côte d'Azur</region>
<region type="old region">Provence-Alpes-Côte d'Azur</region>
<settlement type="city">Marseille</settlement>
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<author><name sortKey="Bonnet, Anne Marie" sort="Bonnet, Anne Marie" uniqKey="Bonnet A" first="Anne-Marie" last="Bonnet">Anne-Marie Bonnet</name>
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<s2>Paris</s2>
<s3>FRA</s3>
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<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
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</placeName>
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<author><name sortKey="Brefel Courbon, Christine" sort="Brefel Courbon, Christine" uniqKey="Brefel Courbon C" first="Christine" last="Brefel-Courbon">Christine Brefel-Courbon</name>
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<s2>Toulouse</s2>
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</inist:fA14>
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</placeName>
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</author>
<author><name sortKey="Cesaro, Pierre" sort="Cesaro, Pierre" uniqKey="Cesaro P" first="Pierre" last="Cesaro">Pierre Cesaro</name>
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<s3>FRA</s3>
<sZ>6 aut.</sZ>
<sZ>13 aut.</sZ>
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<author><name sortKey="Damier, Philippe" sort="Damier, Philippe" uniqKey="Damier P" first="Philippe" last="Damier">Philippe Damier</name>
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<s2>Nantes</s2>
<s3>FRA</s3>
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</inist:fA14>
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<placeName><region type="region">Pays de la Loire</region>
<region type="old region">Pays de la Loire</region>
<settlement type="city">Nantes</settlement>
</placeName>
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</author>
<author><name sortKey="Debilly, Berengere" sort="Debilly, Berengere" uniqKey="Debilly B" first="Bérengère" last="Debilly">Bérengère Debilly</name>
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<region type="old region">Auvergne (région administrative)</region>
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<author><name sortKey="Durif, Frank" sort="Durif, Frank" uniqKey="Durif F" first="Frank" last="Durif">Frank Durif</name>
<affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Service de Neurologie, Hôpital Gabriel Montpied, CHU Clermont-Ferrand, Faculty of Medecine, University of Clermont, 1, EA 3845</s1>
<s2>Clermont-Ferrand</s2>
<s3>FRA</s3>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Auvergne (région administrative)</region>
<settlement type="city">Clermont-Ferrand</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Galitzky, Monique" sort="Galitzky, Monique" uniqKey="Galitzky M" first="Monique" last="Galitzky">Monique Galitzky</name>
<affiliation wicri:level="3"><inist:fA14 i1="01"><s1>Departments of Clinical Pharmacology and Neurosciences, INSERM Clinical Investigation Center CIC-9302 and UMR-825, CHU Toulouse-Purpan and University Paul Sabatier</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Occitanie (région administrative)</region>
<region type="old region">Midi-Pyrénées</region>
<settlement type="city">Toulouse</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Grouin, Jean Marie" sort="Grouin, Jean Marie" uniqKey="Grouin J" first="Jean-Marie" last="Grouin">Jean-Marie Grouin</name>
<affiliation wicri:level="4"><inist:fA14 i1="08"><s1>Laboratoire de Biostatistiques, INSERM U 657, Université de Rouen</s1>
<s2>Rouen</s2>
<s3>FRA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Région Normandie</region>
<region type="old region">Haute-Normandie</region>
<settlement type="city">Rouen</settlement>
</placeName>
<orgName type="university">Université de Rouen</orgName>
</affiliation>
</author>
<author><name sortKey="Pennaforte, Sylvie" sort="Pennaforte, Sylvie" uniqKey="Pennaforte S" first="Sylvie" last="Pennaforte">Sylvie Pennaforte</name>
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<country>France</country>
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</affiliation>
</author>
<author><name sortKey="Villafane, Gabriel" sort="Villafane, Gabriel" uniqKey="Villafane G" first="Gabriel" last="Villafane">Gabriel Villafane</name>
<affiliation wicri:level="3"><inist:fA14 i1="05"><s1>Department of Clinical Neurosciences, INSERM U 841, CHU Henri Mondor</s1>
<s2>Créteil 94000</s2>
<s3>FRA</s3>
<sZ>6 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region" nuts="2">Île-de-France</region>
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</author>
<author><name sortKey="Yaici, Sadek" sort="Yaici, Sadek" uniqKey="Yaici S" first="Sadek" last="Yaici">Sadek Yaici</name>
<affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Centre d'Investigation Clinique, Fédération des maladies du Système Nerveux, INSERM U 679, CHU Pitié-Salpétrière</s1>
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<s3>FRA</s3>
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<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
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<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</settlement>
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</author>
<author><name sortKey="Agid, Yves" sort="Agid, Yves" uniqKey="Agid Y" first="Yves" last="Agid">Yves Agid</name>
<affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Centre d'Investigation Clinique, Fédération des maladies du Système Nerveux, INSERM U 679, CHU Pitié-Salpétrière</s1>
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<s3>FRA</s3>
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<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<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>
<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="2010">2010</date>
</imprint>
</series>
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<seriesStmt><title level="j" type="main">Movement disorders</title>
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<idno type="ISSN">0885-3185</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Dopamine agonist</term>
<term>Double blind study</term>
<term>Fluctuations</term>
<term>Nervous system diseases</term>
<term>Parkinson disease</term>
<term>Piribedil</term>
<term>Placebo</term>
<term>Single dose</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term>
<term>Pathologie du   système nerveux</term>
<term>Piribédil</term>
<term>Dose unique</term>
<term>Placebo</term>
<term>Etude double insu</term>
<term>Fluctuation</term>
<term>Stimulant dopaminergique</term>
<term>Apomorphine</term>
</keywords>
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</teiHeader>
<front><div type="abstract" xml:lang="en">S90049, a novel sublingual formulation of the non-ergoline D<sub>2</sub>
-D<sub>3</sub>
 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 was superior 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.</div>
</front>
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<fA08 i1="01" i2="1" l="ENG"><s1>Orodispersible Sublingual Piribedil to Abort OFF Episodes: A Single Dose Placebo-Controlled, Randomized, Double-Blind, Cross-Over Study</s1>
</fA08>
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</fA11>
<fA11 i1="15" i2="1"><s1>AGID (Yves)</s1>
</fA11>
<fA14 i1="01"><s1>Departments of Clinical Pharmacology and Neurosciences, INSERM Clinical Investigation Center CIC-9302 and UMR-825, CHU Toulouse-Purpan and University Paul Sabatier</s1>
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<sZ>1 aut.</sZ>
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<sZ>10 aut.</sZ>
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<fA14 i1="02"><s1>Service de Neurologie et Pathologie du Mouvement, Pôle Neurosciences cliniques, CHU Timone</s1>
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<s3>FRA</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Clinical Investigation Centre (CIC-UPCET) and Department of Clinical Pharmacology, UMR-CNRS 6193 Institute of Cognitive Neurosciences, CHU Timone</s1>
<s2>Marseille</s2>
<s3>FRA</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Centre d'Investigation Clinique, Fédération des maladies du Système Nerveux, INSERM U 679, CHU Pitié-Salpétrière</s1>
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<s3>FRA</s3>
<sZ>4 aut.</sZ>
<sZ>14 aut.</sZ>
<sZ>15 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Department of Clinical Neurosciences, INSERM U 841, CHU Henri Mondor</s1>
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<s3>FRA</s3>
<sZ>6 aut.</sZ>
<sZ>13 aut.</sZ>
</fA14>
<fA14 i1="06"><s1>INSERM, Clinical Investigation Center CIC, and Clinique Neurologique, CHU Nantes</s1>
<s2>Nantes</s2>
<s3>FRA</s3>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>Service de Neurologie, Hôpital Gabriel Montpied, CHU Clermont-Ferrand, Faculty of Medecine, University of Clermont, 1, EA 3845</s1>
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<s3>FRA</s3>
<sZ>8 aut.</sZ>
<sZ>9 aut.</sZ>
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<fA14 i1="08"><s1>Laboratoire de Biostatistiques, INSERM U 657, Université de Rouen</s1>
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<sZ>11 aut.</sZ>
</fA14>
<fA14 i1="09"><s1>Institut de Recherches Internationales Servier</s1>
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<s3>FRA</s3>
<sZ>12 aut.</sZ>
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<fA20><s1>368-376</s1>
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<fC01 i1="01" l="ENG"><s0>S90049, a novel sublingual formulation of the non-ergoline D<sub>2</sub>
-D<sub>3</sub>
 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 was superior 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.</s0>
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<fC03 i1="03" i2="X" l="ENG"><s0>Piribedil</s0>
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</list>
<tree><country name="France"><region name="Occitanie (région administrative)"><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
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<name sortKey="Blin, Olivier" sort="Blin, Olivier" uniqKey="Blin O" first="Olivier" last="Blin">Olivier Blin</name>
<name sortKey="Bonnet, Anne Marie" sort="Bonnet, Anne Marie" uniqKey="Bonnet A" first="Anne-Marie" last="Bonnet">Anne-Marie Bonnet</name>
<name sortKey="Brefel Courbon, Christine" sort="Brefel Courbon, Christine" uniqKey="Brefel Courbon C" first="Christine" last="Brefel-Courbon">Christine Brefel-Courbon</name>
<name sortKey="Cesaro, Pierre" sort="Cesaro, Pierre" uniqKey="Cesaro P" first="Pierre" last="Cesaro">Pierre Cesaro</name>
<name sortKey="Damier, Philippe" sort="Damier, Philippe" uniqKey="Damier P" first="Philippe" last="Damier">Philippe Damier</name>
<name sortKey="Debilly, Berengere" sort="Debilly, Berengere" uniqKey="Debilly B" first="Bérengère" last="Debilly">Bérengère Debilly</name>
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<name sortKey="Pennaforte, Sylvie" sort="Pennaforte, Sylvie" uniqKey="Pennaforte S" first="Sylvie" last="Pennaforte">Sylvie Pennaforte</name>
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<name sortKey="Yaici, Sadek" sort="Yaici, Sadek" uniqKey="Yaici S" first="Sadek" last="Yaici">Sadek Yaici</name>
</country>
</tree>
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</record>

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	La maladie de Parkinson en France (serveur d'exploration)
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La maladie de Parkinson en France (serveur d'exploration)

Orodispersible Sublingual Piribedil to Abort OFF Episodes: A Single Dose Placebo-Controlled, Randomized, Double-Blind, Cross-Over Study

Orodispersible Sublingual Piribedil to Abort OFF Episodes: A Single Dose Placebo-Controlled, Randomized, Double-Blind, Cross-Over Study

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