MovDisordV3, Main, Exploration, bibRecord, 001B37

Orodispersible sublingual piribedil to abort OFF episodes: A single dose placebo‐controlled, randomized, double‐blind, cross‐over study

Identifieur interne : 001B37 ( Main/Exploration ); précédent : 001B36; suivant : 001B38

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 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.

RBID : ISTEX:336E94F27649D97517D84497998FD3E90304F4EF

Descripteurs français

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

English descriptors

KwdEn :
- Administration, Sublingual, Antiparkinson Agents (administration & dosage), Apomorphine (administration & dosage), Cross-Over Studies, Dopamine agonist, Dose-Response Relationship, Drug, Double blind study, Double-Blind Method, Drug Administration Routes, Fluctuations, France, Humans, Logistic Models, Nervous system diseases, Parkinson Disease (drug therapy), Parkinson disease, Parkinson's disease, Piribedil, Piribedil (administration & dosage), Placebo, Proportional Hazards Models, S90049, Severity of Illness Index, Single dose, 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:

https://api.istex.fr/document/336E94F27649D97517D84497998FD3E90304F4EF/fulltext/pdf

DOI: 10.1002/mds.22922

Affiliations:

Le document en format XML

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<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>Dopamine agonist</term>
<term>Dose-Response Relationship, Drug</term>
<term>Double blind study</term>
<term>Double-Blind Method</term>
<term>Drug Administration Routes</term>
<term>Fluctuations</term>
<term>France</term>
<term>Humans</term>
<term>Logistic Models</term>
<term>Nervous system diseases</term>
<term>Parkinson Disease (drug therapy)</term>
<term>Parkinson disease</term>
<term>Parkinson's disease</term>
<term>Piribedil</term>
<term>Piribedil (administration & dosage)</term>
<term>Placebo</term>
<term>Proportional Hazards Models</term>
<term>S90049</term>
<term>Severity of Illness Index</term>
<term>Single dose</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>
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<keywords scheme="MESH" type="geographic" xml:lang="en"><term>France</term>
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<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="Pascal" xml:lang="fr"><term>Apomorphine</term>
<term>Dose unique</term>
<term>Etude double insu</term>
<term>Fluctuation</term>
<term>Maladie de Parkinson</term>
<term>Pathologie du   système nerveux</term>
<term>Piribédil</term>
<term>Placebo</term>
<term>Stimulant dopaminergique</term>
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<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>
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<affiliations><list><country><li>France</li>
</country>
<region><li>Midi-Pyrénées</li>
<li>Région Bourgogne</li>
<li>Île-de-France</li>
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<settlement><li>Marseille</li>
<li>Nantes</li>
<li>Paris</li>
<li>Rouen</li>
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<orgName><li>Hôpital de la Salpêtrière</li>
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<name sortKey="Brefel Ourbon, Christine" sort="Brefel Ourbon, Christine" uniqKey="Brefel Ourbon C" first="Christine" last="Brefel-Courbon">Christine Brefel-Courbon</name>
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<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="Grouin, Jean Arie" sort="Grouin, Jean Arie" uniqKey="Grouin J" first="Jean-Marie" last="Grouin">Jean-Marie Grouin</name>
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<name sortKey="Yaici, Sadek" sort="Yaici, Sadek" uniqKey="Yaici S" first="Sadek" last="Yaici">Sadek Yaici</name>
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Movement Disorders (revue)

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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	Movement Disorders (revue)
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