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

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End-of-dose akinesia after a single intravenous infusion of the dopaminergic agonist piribedil in Parkinson's disease patients : A pharmacokinetic/pharmacodynamic, randomized, double-blind study

Identifieur interne : 000C57 ( PascalFrancis/Corpus ); précédent : 000C56; suivant : 000C58

End-of-dose akinesia after a single intravenous infusion of the dopaminergic agonist piribedil in Parkinson's disease patients : A pharmacokinetic/pharmacodynamic, randomized, double-blind study

Auteurs : Nicolas Simon ; Joëlle Micallef ; Jean-Charles Reynier ; Monique Lesourd ; Tatiana Witjas ; André Alicherif ; Jean-Philippe Azulay ; Olivier Blin

Source :

RBID : Pascal:05-0387232

Descripteurs français

English descriptors

Abstract

This randomized, double-blind trial was designed to define the possible relationship between piribedil plasma concentrations and the decrease of the Unified Parkinson's Disease Rating Scale (UPDRS) motor score or the switch from off to on state after single intravenous infusion. Ten fluctuating patients with idiopathic Parkinson's disease (PD) received escalating doses of piribedil (2-16 mg) and placebo. Starting from 2 mg, piribedil was effective in reducing the motor deficit (UPDRS, motor score) including akinesia at the first evaluation time point of 15 minutes, and in reversing off state of 7 of 10 patients. The doses were equally effective, although the effect was more sustained with the highest dose of 16 mg. Piribedil was well tolerated up to a 16-mg dose and pharmacokinetics were linear up to the 16-mg dose. Plasma levels of piribedil were not correlated to the motor score improvement or switch from off→on. In conclusion, a short single infusion of piribedil at 2 to 16 mg was safe and effective in improving motor symptoms, including akinesia, of fluctuating PD patients.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

pA  
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A03   1    @0 Mov. disord.
A05       @2 20
A06       @2 7
A08 01  1  ENG  @1 End-of-dose akinesia after a single intravenous infusion of the dopaminergic agonist piribedil in Parkinson's disease patients : A pharmacokinetic/pharmacodynamic, randomized, double-blind study
A11 01  1    @1 SIMON (Nicolas)
A11 02  1    @1 MICALLEF (Joëlle)
A11 03  1    @1 REYNIER (Jean-Charles)
A11 04  1    @1 LESOURD (Monique)
A11 05  1    @1 WITJAS (Tatiana)
A11 06  1    @1 ALICHERIF (André)
A11 07  1    @1 AZULAY (Jean-Philippe)
A11 08  1    @1 BLIN (Olivier)
A14 01      @1 Laboratoire de Pharmacologie Medicale et Clinique, Centre Hospitalier Universitaire Timone @2 Marseille @3 FRA @Z 1 aut.
A14 02      @1 CPCET, Centre Hospitalier Universitaire Timone, Institut des Neurosciences Cognitives de la Mediterran, CNRS-Universite de la Méditerranée @2 Marseille @3 FRA @Z 2 aut. @Z 3 aut. @Z 5 aut. @Z 6 aut. @Z 7 aut. @Z 8 aut.
A14 03      @1 Institut de Recherches Internationales Servier @2 Courbevoie @3 FRA @Z 4 aut.
A20       @1 803-809
A21       @1 2005
A23 01      @0 ENG
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A44       @0 0000 @1 © 2005 INIST-CNRS. All rights reserved.
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A47 01  1    @0 05-0387232
A60       @1 P
A61       @0 A
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A66 01      @0 USA
C01 01    ENG  @0 This randomized, double-blind trial was designed to define the possible relationship between piribedil plasma concentrations and the decrease of the Unified Parkinson's Disease Rating Scale (UPDRS) motor score or the switch from off to on state after single intravenous infusion. Ten fluctuating patients with idiopathic Parkinson's disease (PD) received escalating doses of piribedil (2-16 mg) and placebo. Starting from 2 mg, piribedil was effective in reducing the motor deficit (UPDRS, motor score) including akinesia at the first evaluation time point of 15 minutes, and in reversing off state of 7 of 10 patients. The doses were equally effective, although the effect was more sustained with the highest dose of 16 mg. Piribedil was well tolerated up to a 16-mg dose and pharmacokinetics were linear up to the 16-mg dose. Plasma levels of piribedil were not correlated to the motor score improvement or switch from off→on. In conclusion, a short single infusion of piribedil at 2 to 16 mg was safe and effective in improving motor symptoms, including akinesia, of fluctuating PD patients.
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C03 09  X  FRE  @0 Etude double insu @5 14
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C03 09  X  SPA  @0 Estudio doble ciego @5 14
C03 10  X  FRE  @0 Pharmacodynamie @4 CD @5 96
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Format Inist (serveur)

NO : PASCAL 05-0387232 INIST
ET : End-of-dose akinesia after a single intravenous infusion of the dopaminergic agonist piribedil in Parkinson's disease patients : A pharmacokinetic/pharmacodynamic, randomized, double-blind study
AU : SIMON (Nicolas); MICALLEF (Joëlle); REYNIER (Jean-Charles); LESOURD (Monique); WITJAS (Tatiana); ALICHERIF (André); AZULAY (Jean-Philippe); BLIN (Olivier)
AF : Laboratoire de Pharmacologie Medicale et Clinique, Centre Hospitalier Universitaire Timone/Marseille/France (1 aut.); CPCET, Centre Hospitalier Universitaire Timone, Institut des Neurosciences Cognitives de la Mediterran, CNRS-Universite de la Méditerranée/Marseille/France (2 aut., 3 aut., 5 aut., 6 aut., 7 aut., 8 aut.); Institut de Recherches Internationales Servier/Courbevoie/France (4 aut.)
DT : Publication en série; Niveau analytique
SO : Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2005; Vol. 20; No. 7; Pp. 803-809; Bibl. 21 ref.
LA : Anglais
EA : This randomized, double-blind trial was designed to define the possible relationship between piribedil plasma concentrations and the decrease of the Unified Parkinson's Disease Rating Scale (UPDRS) motor score or the switch from off to on state after single intravenous infusion. Ten fluctuating patients with idiopathic Parkinson's disease (PD) received escalating doses of piribedil (2-16 mg) and placebo. Starting from 2 mg, piribedil was effective in reducing the motor deficit (UPDRS, motor score) including akinesia at the first evaluation time point of 15 minutes, and in reversing off state of 7 of 10 patients. The doses were equally effective, although the effect was more sustained with the highest dose of 16 mg. Piribedil was well tolerated up to a 16-mg dose and pharmacokinetics were linear up to the 16-mg dose. Plasma levels of piribedil were not correlated to the motor score improvement or switch from off→on. In conclusion, a short single infusion of piribedil at 2 to 16 mg was safe and effective in improving motor symptoms, including akinesia, of fluctuating PD patients.
CC : 002B17; 002B17G; 002B17F
FD : Système nerveux pathologie; Akinésie; Parkinson maladie; Dose unique; Voie intraveineuse; Piribédil; Homme; Pharmacocinétique; Etude double insu; Pharmacodynamie
FG : Encéphale pathologie; Système nerveux central pathologie; Trouble moteur; Trouble neurologique; Extrapyramidal syndrome; Maladie dégénérative
ED : Nervous system diseases; Akinesia; Parkinson disease; Single dose; Intravenous administration; Piribedil; Human; Pharmacokinetics; Double blind study; Pharmacodynamics
EG : Cerebral disorder; Central nervous system disease; Motor system disorder; Neurological disorder; Extrapyramidal syndrome; Degenerative disease
SD : Sistema nervioso patología; Aquinesia; Parkinson enfermedad; Dosis única; Vía intravenosa; Piribedil; Hombre; Farmacocinética; Estudio doble ciego
LO : INIST-20953.354000132363110040
ID : 05-0387232

Links to Exploration step

Pascal:05-0387232

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<div type="abstract" xml:lang="en">This randomized, double-blind trial was designed to define the possible relationship between piribedil plasma concentrations and the decrease of the Unified Parkinson's Disease Rating Scale (UPDRS) motor score or the switch from off to on state after single intravenous infusion. Ten fluctuating patients with idiopathic Parkinson's disease (PD) received escalating doses of piribedil (2-16 mg) and placebo. Starting from 2 mg, piribedil was effective in reducing the motor deficit (UPDRS, motor score) including akinesia at the first evaluation time point of 15 minutes, and in reversing off state of 7 of 10 patients. The doses were equally effective, although the effect was more sustained with the highest dose of 16 mg. Piribedil was well tolerated up to a 16-mg dose and pharmacokinetics were linear up to the 16-mg dose. Plasma levels of piribedil were not correlated to the motor score improvement or switch from off→on. In conclusion, a short single infusion of piribedil at 2 to 16 mg was safe and effective in improving motor symptoms, including akinesia, of fluctuating PD patients.</div>
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<fA06>
<s2>7</s2>
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<fA08 i1="01" i2="1" l="ENG">
<s1>End-of-dose akinesia after a single intravenous infusion of the dopaminergic agonist piribedil in Parkinson's disease patients : A pharmacokinetic/pharmacodynamic, randomized, double-blind study</s1>
</fA08>
<fA11 i1="01" i2="1">
<s1>SIMON (Nicolas)</s1>
</fA11>
<fA11 i1="02" i2="1">
<s1>MICALLEF (Joëlle)</s1>
</fA11>
<fA11 i1="03" i2="1">
<s1>REYNIER (Jean-Charles)</s1>
</fA11>
<fA11 i1="04" i2="1">
<s1>LESOURD (Monique)</s1>
</fA11>
<fA11 i1="05" i2="1">
<s1>WITJAS (Tatiana)</s1>
</fA11>
<fA11 i1="06" i2="1">
<s1>ALICHERIF (André)</s1>
</fA11>
<fA11 i1="07" i2="1">
<s1>AZULAY (Jean-Philippe)</s1>
</fA11>
<fA11 i1="08" i2="1">
<s1>BLIN (Olivier)</s1>
</fA11>
<fA14 i1="01">
<s1>Laboratoire de Pharmacologie Medicale et Clinique, Centre Hospitalier Universitaire Timone</s1>
<s2>Marseille</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
</fA14>
<fA14 i1="02">
<s1>CPCET, Centre Hospitalier Universitaire Timone, Institut des Neurosciences Cognitives de la Mediterran, CNRS-Universite de la Méditerranée</s1>
<s2>Marseille</s2>
<s3>FRA</s3>
<sZ>2 aut.</sZ>
<sZ>3 aut.</sZ>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</fA14>
<fA14 i1="03">
<s1>Institut de Recherches Internationales Servier</s1>
<s2>Courbevoie</s2>
<s3>FRA</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA20>
<s1>803-809</s1>
</fA20>
<fA21>
<s1>2005</s1>
</fA21>
<fA23 i1="01">
<s0>ENG</s0>
</fA23>
<fA43 i1="01">
<s1>INIST</s1>
<s2>20953</s2>
<s5>354000132363110040</s5>
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<s0>0000</s0>
<s1>© 2005 INIST-CNRS. All rights reserved.</s1>
</fA44>
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<s0>21 ref.</s0>
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<fA47 i1="01" i2="1">
<s0>05-0387232</s0>
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<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>This randomized, double-blind trial was designed to define the possible relationship between piribedil plasma concentrations and the decrease of the Unified Parkinson's Disease Rating Scale (UPDRS) motor score or the switch from off to on state after single intravenous infusion. Ten fluctuating patients with idiopathic Parkinson's disease (PD) received escalating doses of piribedil (2-16 mg) and placebo. Starting from 2 mg, piribedil was effective in reducing the motor deficit (UPDRS, motor score) including akinesia at the first evaluation time point of 15 minutes, and in reversing off state of 7 of 10 patients. The doses were equally effective, although the effect was more sustained with the highest dose of 16 mg. Piribedil was well tolerated up to a 16-mg dose and pharmacokinetics were linear up to the 16-mg dose. Plasma levels of piribedil were not correlated to the motor score improvement or switch from off→on. In conclusion, a short single infusion of piribedil at 2 to 16 mg was safe and effective in improving motor symptoms, including akinesia, of fluctuating PD patients.</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>002B17F</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>Akinésie</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG">
<s0>Akinesia</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA">
<s0>Aquinesia</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>Dose unique</s0>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Single dose</s0>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Dosis única</s0>
<s5>09</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Voie intraveineuse</s0>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Intravenous administration</s0>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Vía intravenosa</s0>
<s5>10</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Piribédil</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Piribedil</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Piribedil</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>11</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE">
<s0>Homme</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG">
<s0>Human</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA">
<s0>Hombre</s0>
<s5>12</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE">
<s0>Pharmacocinétique</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Pharmacokinetics</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Farmacocinética</s0>
<s5>13</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Etude double insu</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Double blind study</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Estudio doble ciego</s0>
<s5>14</s5>
</fC03>
<fC03 i1="10" i2="X" l="FRE">
<s0>Pharmacodynamie</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC03 i1="10" i2="X" l="ENG">
<s0>Pharmacodynamics</s0>
<s4>CD</s4>
<s5>96</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE">
<s0>Encéphale pathologie</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="ENG">
<s0>Cerebral disorder</s0>
<s5>37</s5>
</fC07>
<fC07 i1="01" i2="X" l="SPA">
<s0>Encéfalo patología</s0>
<s5>37</s5>
</fC07>
<fC07 i1="02" i2="X" l="FRE">
<s0>Système nerveux central pathologie</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG">
<s0>Central nervous system disease</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA">
<s0>Sistema nervosio central patología</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE">
<s0>Trouble moteur</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG">
<s0>Motor system disorder</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA">
<s0>Trastorno motor</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE">
<s0>Trouble neurologique</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG">
<s0>Neurological disorder</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA">
<s0>Trastorno neurológico</s0>
<s5>40</s5>
</fC07>
<fC07 i1="05" i2="X" l="FRE">
<s0>Extrapyramidal syndrome</s0>
<s5>41</s5>
</fC07>
<fC07 i1="05" i2="X" l="ENG">
<s0>Extrapyramidal syndrome</s0>
<s5>41</s5>
</fC07>
<fC07 i1="05" i2="X" l="SPA">
<s0>Extrapiramidal síndrome</s0>
<s5>41</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE">
<s0>Maladie dégénérative</s0>
<s5>42</s5>
</fC07>
<fC07 i1="06" i2="X" l="ENG">
<s0>Degenerative disease</s0>
<s5>42</s5>
</fC07>
<fC07 i1="06" i2="X" l="SPA">
<s0>Enfermedad degenerativa</s0>
<s5>42</s5>
</fC07>
<fN21>
<s1>269</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
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<server>
<NO>PASCAL 05-0387232 INIST</NO>
<ET>End-of-dose akinesia after a single intravenous infusion of the dopaminergic agonist piribedil in Parkinson's disease patients : A pharmacokinetic/pharmacodynamic, randomized, double-blind study</ET>
<AU>SIMON (Nicolas); MICALLEF (Joëlle); REYNIER (Jean-Charles); LESOURD (Monique); WITJAS (Tatiana); ALICHERIF (André); AZULAY (Jean-Philippe); BLIN (Olivier)</AU>
<AF>Laboratoire de Pharmacologie Medicale et Clinique, Centre Hospitalier Universitaire Timone/Marseille/France (1 aut.); CPCET, Centre Hospitalier Universitaire Timone, Institut des Neurosciences Cognitives de la Mediterran, CNRS-Universite de la Méditerranée/Marseille/France (2 aut., 3 aut., 5 aut., 6 aut., 7 aut., 8 aut.); Institut de Recherches Internationales Servier/Courbevoie/France (4 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2005; Vol. 20; No. 7; Pp. 803-809; Bibl. 21 ref.</SO>
<LA>Anglais</LA>
<EA>This randomized, double-blind trial was designed to define the possible relationship between piribedil plasma concentrations and the decrease of the Unified Parkinson's Disease Rating Scale (UPDRS) motor score or the switch from off to on state after single intravenous infusion. Ten fluctuating patients with idiopathic Parkinson's disease (PD) received escalating doses of piribedil (2-16 mg) and placebo. Starting from 2 mg, piribedil was effective in reducing the motor deficit (UPDRS, motor score) including akinesia at the first evaluation time point of 15 minutes, and in reversing off state of 7 of 10 patients. The doses were equally effective, although the effect was more sustained with the highest dose of 16 mg. Piribedil was well tolerated up to a 16-mg dose and pharmacokinetics were linear up to the 16-mg dose. Plasma levels of piribedil were not correlated to the motor score improvement or switch from off→on. In conclusion, a short single infusion of piribedil at 2 to 16 mg was safe and effective in improving motor symptoms, including akinesia, of fluctuating PD patients.</EA>
<CC>002B17; 002B17G; 002B17F</CC>
<FD>Système nerveux pathologie; Akinésie; Parkinson maladie; Dose unique; Voie intraveineuse; Piribédil; Homme; Pharmacocinétique; Etude double insu; Pharmacodynamie</FD>
<FG>Encéphale pathologie; Système nerveux central pathologie; Trouble moteur; Trouble neurologique; Extrapyramidal syndrome; Maladie dégénérative</FG>
<ED>Nervous system diseases; Akinesia; Parkinson disease; Single dose; Intravenous administration; Piribedil; Human; Pharmacokinetics; Double blind study; Pharmacodynamics</ED>
<EG>Cerebral disorder; Central nervous system disease; Motor system disorder; Neurological disorder; Extrapyramidal syndrome; Degenerative disease</EG>
<SD>Sistema nervioso patología; Aquinesia; Parkinson enfermedad; Dosis única; Vía intravenosa; Piribedil; Hombre; Farmacocinética; Estudio doble ciego</SD>
<LO>INIST-20953.354000132363110040</LO>
<ID>05-0387232</ID>
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