ParkinsonFranceV1, PascalFrancis, Corpus, bibRecord, 000897

Tesofensine (NS 2330), a Monoamine Reuptake Inhibitor, in Patients With Advanced Parkinson Disease and Motor Fluctuations : The ADVANS Study

Identifieur interne : 000897 ( PascalFrancis/Corpus ); précédent : 000896; suivant : 000898

Tesofensine (NS 2330), a Monoamine Reuptake Inhibitor, in Patients With Advanced Parkinson Disease and Motor Fluctuations : The ADVANS Study

Auteurs : Olivier Rascol ; Werner Poewe ; Andrew Lees ; Marina Aristin ; Laurence Salin ; Nolwenn Juhel ; Lisa Waldhauser ; Thomas Schindler

Source :

Archives of neurology : (Chicago) [ 0003-9942 ] ; 2008.

RBID : Pascal:08-0248382

Descripteurs français

Pascal (Inist)
- Maladie de Parkinson, Pathologie du système nerveux, Tésofensine, Inhibiteur recapture, Homme, Stade avancé, Fluctuation.

English descriptors

KwdEn :
- Advanced stage, Fluctuations, Human, Nervous system diseases, Parkinson disease, Reuptake inhibitor, Tesofensine.

Abstract

Objective: To assess the safety and efficacy of tesofensine, a triple monoamine reuptake inhibitor, in patients with advanced Parkinson disease (PD). Design: A pilot phase 2, randomized, double-blind, placebo-controlled, parallel-group trial. The study occurred in hospital-based outpatient clinics and in clinical trial units. Patients with advanced PD and levodoparelated motor fluctuations were enrolled. Tesofensine (0.125, 0.25, 0.5, or 1 mg) or placebo tablets were administered once daily for 14 weeks. Main Outcome Measures: Coprimary end points were the changes from baseline in Unified Parkinson Disease Rating Scale (UPDRS) subscale II (activities of daily living) plus subscale III (motor function) total score and in percentage of waking hours spent in "off" time noted in self-scoring diaries. Secondary end points were safety, pharmacokinetics, responder analysis (≥20% reduction in UPDRS score and in off time), and changes in percentage of waking hours spent in "on" time with and without troublesome dyskinesia. Results: The adjusted mean differences (relative to placebo) were -4.7 points in UPDRS subscale II plus subscale III total score (P=.005) with tesofensine, 0.5 mg, and -7.1% in off time (-68 minutes, P=.02) with tesofensine, 0.25 mg. Other dosages did not induce statistically significant effects. The plasma concentration increased with the dosage, but no clear dose-response relationship was observed. Gastrointestinal tract and neuropsychiatric adverse events were more frequent with tesofensine than with placebo, especially at the higher dosages. Conclusions: Patients with PD in advanced stages showed modest improvements in UPDRS subscale II plus subscale III total score and in off time when treated with tesofensine, but a dose-response relationship could not be established for efficacy, while adverse drug reactions tended to be more frequent at higher dosages.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

A01	`01`	`1`		`@0 0003-9942`
A02	`01`			`@0 ARNEAS`
A03		`1`		`@0 Arch. neurol. : (Chic.)`
A05				`@2 65`
A06				`@2 5`
A08	`01`	`1`	`ENG`	`@1 Tesofensine (NS 2330), a Monoamine Reuptake Inhibitor, in Patients With Advanced Parkinson Disease and Motor Fluctuations : The ADVANS Study`
A11	`01`	`1`		`@1 RASCOL (Olivier)`
A11	`02`	`1`		`@1 POEWE (Werner)`
A11	`03`	`1`		`@1 LEES (Andrew)`
A11	`04`	`1`		`@1 ARISTIN (Marina)`
A11	`05`	`1`		`@1 SALIN (Laurence)`
A11	`06`	`1`		`@1 JUHEL (Nolwenn)`
A11	`07`	`1`		`@1 WALDHAUSER (Lisa)`
A11	`08`	`1`		`@1 SCHINDLER (Thomas)`
A14	`01`			`@1 Laboratoire de Pharmacologie Médicale et Clinique, Pôle Neurosciences, Centre d'Investigations Cliniques, Institut National de la Santé et de la Récherche Médicale, Unité 825, University Hospital @2 Toulouse @3 FRA @Z 1 aut. @Z 4 aut.`
A14	`02`			`@1 Department of Neurology, Universitätskliniken @2 Innsbruck @3 AUT @Z 2 aut.`
A14	`03`			`@1 Reta Lila Weston Institute for Neurological Studies, Institute ofNeurology, University College London @2 London @3 GBR @Z 3 aut.`
A14	`04`			`@1 Medical and Drug Regulatory Affairs, Boehringer Ingelheim @2 Reims @3 FRA @Z 5 aut. @Z 6 aut.`
A14	`05`			`@1 Clinical Research, Boehringer Ingelheim @2 Biberach @3 DEU @Z 7 aut. @Z 8 aut.`
A17	`01`	`1`		`@1 ADVANS Study Group @3 INC`
A20				`@1 577-583`
A21				`@1 2008`
A23	`01`			`@0 ENG`
A43	`01`			`@1 INIST @2 2048B @5 354000195879560010`
A44				`@0 0000 @1 © 2008 INIST-CNRS. All rights reserved.`
A45				`@0 16 ref.`
A47	`01`	`1`		`@0 08-0248382`
A60				`@1 P`
A61				`@0 A`
A64	`01`	`1`		`@0 Archives of neurology : (Chicago)`
A66	`01`			`@0 USA`
C01	`01`		`ENG`	@0 Objective: To assess the safety and efficacy of tesofensine, a triple monoamine reuptake inhibitor, in patients with advanced Parkinson disease (PD). Design: A pilot phase 2, randomized, double-blind, placebo-controlled, parallel-group trial. The study occurred in hospital-based outpatient clinics and in clinical trial units. Patients with advanced PD and levodoparelated motor fluctuations were enrolled. Tesofensine (0.125, 0.25, 0.5, or 1 mg) or placebo tablets were administered once daily for 14 weeks. Main Outcome Measures: Coprimary end points were the changes from baseline in Unified Parkinson Disease Rating Scale (UPDRS) subscale II (activities of daily living) plus subscale III (motor function) total score and in percentage of waking hours spent in "off" time noted in self-scoring diaries. Secondary end points were safety, pharmacokinetics, responder analysis (≥20% reduction in UPDRS score and in off time), and changes in percentage of waking hours spent in "on" time with and without troublesome dyskinesia. Results: The adjusted mean differences (relative to placebo) were -4.7 points in UPDRS subscale II plus subscale III total score (P=.005) with tesofensine, 0.5 mg, and -7.1% in off time (-68 minutes, P=.02) with tesofensine, 0.25 mg. Other dosages did not induce statistically significant effects. The plasma concentration increased with the dosage, but no clear dose-response relationship was observed. Gastrointestinal tract and neuropsychiatric adverse events were more frequent with tesofensine than with placebo, especially at the higher dosages. Conclusions: Patients with PD in advanced stages showed modest improvements in UPDRS subscale II plus subscale III total score and in off time when treated with tesofensine, but a dose-response relationship could not be established for efficacy, while adverse drug reactions tended to be more frequent at higher dosages.
C02	`01`	`X`		`@0 002B17`
C02	`02`	`X`		`@0 002B17G`
C03	`01`	`X`	`FRE`	`@0 Maladie de Parkinson @2 NM @5 01`
C03	`01`	`X`	`ENG`	`@0 Parkinson disease @2 NM @5 01`
C03	`01`	`X`	`SPA`	`@0 Parkinson enfermedad @2 NM @5 01`
C03	`02`	`X`	`FRE`	`@0 Pathologie du système nerveux @5 02`
C03	`02`	`X`	`ENG`	`@0 Nervous system diseases @5 02`
C03	`02`	`X`	`SPA`	`@0 Sistema nervioso patología @5 02`
C03	`03`	`X`	`FRE`	`@0 Tésofensine @2 FR @5 09`
C03	`03`	`X`	`ENG`	`@0 Tesofensine @2 FR @5 09`
C03	`03`	`X`	`SPA`	`@0 Tesofensina @2 FR @5 09`
C03	`04`	`X`	`FRE`	`@0 Inhibiteur recapture @5 10`
C03	`04`	`X`	`ENG`	`@0 Reuptake inhibitor @5 10`
C03	`04`	`X`	`SPA`	`@0 Inhibidor recaptura @5 10`
C03	`05`	`X`	`FRE`	`@0 Homme @5 11`
C03	`05`	`X`	`ENG`	`@0 Human @5 11`
C03	`05`	`X`	`SPA`	`@0 Hombre @5 11`
C03	`06`	`X`	`FRE`	`@0 Stade avancé @5 12`
C03	`06`	`X`	`ENG`	`@0 Advanced stage @5 12`
C03	`06`	`X`	`SPA`	`@0 Estadio avanzado @5 12`
C03	`07`	`X`	`FRE`	`@0 Fluctuation @5 13`
C03	`07`	`X`	`ENG`	`@0 Fluctuations @5 13`
C03	`07`	`X`	`SPA`	`@0 Fluctuación @5 13`
C07	`01`	`X`	`FRE`	`@0 Pathologie de l'encéphale @5 37`
C07	`01`	`X`	`ENG`	`@0 Cerebral disorder @5 37`
C07	`01`	`X`	`SPA`	`@0 Encéfalo patología @5 37`
C07	`02`	`X`	`FRE`	`@0 Syndrome extrapyramidal @5 38`
C07	`02`	`X`	`ENG`	`@0 Extrapyramidal syndrome @5 38`
C07	`02`	`X`	`SPA`	`@0 Extrapiramidal síndrome @5 38`
C07	`03`	`X`	`FRE`	`@0 Maladie dégénérative @5 39`
C07	`03`	`X`	`ENG`	`@0 Degenerative disease @5 39`
C07	`03`	`X`	`SPA`	`@0 Enfermedad degenerativa @5 39`
C07	`04`	`X`	`FRE`	`@0 Pathologie du système nerveux central @5 40`
C07	`04`	`X`	`ENG`	`@0 Central nervous system disease @5 40`
C07	`04`	`X`	`SPA`	`@0 Sistema nervosio central patología @5 40`
N21				`@1 162`
N44	`01`			`@1 OTO`
N82				`@1 OTO`

Format Inist (serveur)

NO :	PASCAL 08-0248382 INIST
ET :	Tesofensine (NS 2330), a Monoamine Reuptake Inhibitor, in Patients With Advanced Parkinson Disease and Motor Fluctuations : The ADVANS Study
AU :	RASCOL (Olivier); POEWE (Werner); LEES (Andrew); ARISTIN (Marina); SALIN (Laurence); JUHEL (Nolwenn); WALDHAUSER (Lisa); SCHINDLER (Thomas)
AF :	Laboratoire de Pharmacologie Médicale et Clinique, Pôle Neurosciences, Centre d'Investigations Cliniques, Institut National de la Santé et de la Récherche Médicale, Unité 825, University Hospital/Toulouse/France (1 aut., 4 aut.); Department of Neurology, Universitätskliniken/Innsbruck/Autriche (2 aut.); Reta Lila Weston Institute for Neurological Studies, Institute ofNeurology, University College London/London/Royaume-Uni (3 aut.); Medical and Drug Regulatory Affairs, Boehringer Ingelheim/Reims/France (5 aut., 6 aut.); Clinical Research, Boehringer Ingelheim/Biberach/Allemagne (7 aut., 8 aut.)
DT :	Publication en série; Niveau analytique
SO :	Archives of neurology : (Chicago); ISSN 0003-9942; Coden ARNEAS; Etats-Unis; Da. 2008; Vol. 65; No. 5; Pp. 577-583; Bibl. 16 ref.
LA :	Anglais
EA :	Objective: To assess the safety and efficacy of tesofensine, a triple monoamine reuptake inhibitor, in patients with advanced Parkinson disease (PD). Design: A pilot phase 2, randomized, double-blind, placebo-controlled, parallel-group trial. The study occurred in hospital-based outpatient clinics and in clinical trial units. Patients with advanced PD and levodoparelated motor fluctuations were enrolled. Tesofensine (0.125, 0.25, 0.5, or 1 mg) or placebo tablets were administered once daily for 14 weeks. Main Outcome Measures: Coprimary end points were the changes from baseline in Unified Parkinson Disease Rating Scale (UPDRS) subscale II (activities of daily living) plus subscale III (motor function) total score and in percentage of waking hours spent in "off" time noted in self-scoring diaries. Secondary end points were safety, pharmacokinetics, responder analysis (≥20% reduction in UPDRS score and in off time), and changes in percentage of waking hours spent in "on" time with and without troublesome dyskinesia. Results: The adjusted mean differences (relative to placebo) were -4.7 points in UPDRS subscale II plus subscale III total score (P=.005) with tesofensine, 0.5 mg, and -7.1% in off time (-68 minutes, P=.02) with tesofensine, 0.25 mg. Other dosages did not induce statistically significant effects. The plasma concentration increased with the dosage, but no clear dose-response relationship was observed. Gastrointestinal tract and neuropsychiatric adverse events were more frequent with tesofensine than with placebo, especially at the higher dosages. Conclusions: Patients with PD in advanced stages showed modest improvements in UPDRS subscale II plus subscale III total score and in off time when treated with tesofensine, but a dose-response relationship could not be established for efficacy, while adverse drug reactions tended to be more frequent at higher dosages.
CC :	002B17; 002B17G
FD :	Maladie de Parkinson; Pathologie du système nerveux; Tésofensine; Inhibiteur recapture; Homme; Stade avancé; Fluctuation
FG :	Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central
ED :	Parkinson disease; Nervous system diseases; Tesofensine; Reuptake inhibitor; Human; Advanced stage; Fluctuations
EG :	Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease
SD :	Parkinson enfermedad; Sistema nervioso patología; Tesofensina; Inhibidor recaptura; Hombre; Estadio avanzado; Fluctuación
LO :	INIST-2048B.354000195879560010
ID :	08-0248382

Links to Exploration step

Pascal:08-0248382

Le document en format XML

<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">Tesofensine (NS 2330), a Monoamine Reuptake Inhibitor, in Patients With Advanced Parkinson Disease and Motor Fluctuations : The ADVANS Study</title>
<author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
<affiliation><inist:fA14 i1="01"><s1>Laboratoire de Pharmacologie Médicale et Clinique, Pôle Neurosciences, Centre d'Investigations Cliniques, Institut National de la Santé et de la Récherche Médicale, Unité 825, University Hospital</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name>
<affiliation><inist:fA14 i1="02"><s1>Department of Neurology, Universitätskliniken</s1>
<s2>Innsbruck</s2>
<s3>AUT</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees</name>
<affiliation><inist:fA14 i1="03"><s1>Reta Lila Weston Institute for Neurological Studies, Institute ofNeurology, University College London</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Aristin, Marina" sort="Aristin, Marina" uniqKey="Aristin M" first="Marina" last="Aristin">Marina Aristin</name>
<affiliation><inist:fA14 i1="01"><s1>Laboratoire de Pharmacologie Médicale et Clinique, Pôle Neurosciences, Centre d'Investigations Cliniques, Institut National de la Santé et de la Récherche Médicale, Unité 825, University Hospital</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Salin, Laurence" sort="Salin, Laurence" uniqKey="Salin L" first="Laurence" last="Salin">Laurence Salin</name>
<affiliation><inist:fA14 i1="04"><s1>Medical and Drug Regulatory Affairs, Boehringer Ingelheim</s1>
<s2>Reims</s2>
<s3>FRA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Juhel, Nolwenn" sort="Juhel, Nolwenn" uniqKey="Juhel N" first="Nolwenn" last="Juhel">Nolwenn Juhel</name>
<affiliation><inist:fA14 i1="04"><s1>Medical and Drug Regulatory Affairs, Boehringer Ingelheim</s1>
<s2>Reims</s2>
<s3>FRA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Waldhauser, Lisa" sort="Waldhauser, Lisa" uniqKey="Waldhauser L" first="Lisa" last="Waldhauser">Lisa Waldhauser</name>
<affiliation><inist:fA14 i1="05"><s1>Clinical Research, Boehringer Ingelheim</s1>
<s2>Biberach</s2>
<s3>DEU</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Schindler, Thomas" sort="Schindler, Thomas" uniqKey="Schindler T" first="Thomas" last="Schindler">Thomas Schindler</name>
<affiliation><inist:fA14 i1="05"><s1>Clinical Research, Boehringer Ingelheim</s1>
<s2>Biberach</s2>
<s3>DEU</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</titleStmt>
<publicationStmt><idno type="wicri:source">INIST</idno>
<idno type="inist">08-0248382</idno>
<date when="2008">2008</date>
<idno type="stanalyst">PASCAL 08-0248382 INIST</idno>
<idno type="RBID">Pascal:08-0248382</idno>
<idno type="wicri:Area/PascalFrancis/Corpus">000897</idno>
</publicationStmt>
<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Tesofensine (NS 2330), a Monoamine Reuptake Inhibitor, in Patients With Advanced Parkinson Disease and Motor Fluctuations : The ADVANS Study</title>
<author><name sortKey="Rascol, Olivier" sort="Rascol, Olivier" uniqKey="Rascol O" first="Olivier" last="Rascol">Olivier Rascol</name>
<affiliation><inist:fA14 i1="01"><s1>Laboratoire de Pharmacologie Médicale et Clinique, Pôle Neurosciences, Centre d'Investigations Cliniques, Institut National de la Santé et de la Récherche Médicale, Unité 825, University Hospital</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Poewe, Werner" sort="Poewe, Werner" uniqKey="Poewe W" first="Werner" last="Poewe">Werner Poewe</name>
<affiliation><inist:fA14 i1="02"><s1>Department of Neurology, Universitätskliniken</s1>
<s2>Innsbruck</s2>
<s3>AUT</s3>
<sZ>2 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Lees, Andrew" sort="Lees, Andrew" uniqKey="Lees A" first="Andrew" last="Lees">Andrew Lees</name>
<affiliation><inist:fA14 i1="03"><s1>Reta Lila Weston Institute for Neurological Studies, Institute ofNeurology, University College London</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>3 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Aristin, Marina" sort="Aristin, Marina" uniqKey="Aristin M" first="Marina" last="Aristin">Marina Aristin</name>
<affiliation><inist:fA14 i1="01"><s1>Laboratoire de Pharmacologie Médicale et Clinique, Pôle Neurosciences, Centre d'Investigations Cliniques, Institut National de la Santé et de la Récherche Médicale, Unité 825, University Hospital</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>4 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Salin, Laurence" sort="Salin, Laurence" uniqKey="Salin L" first="Laurence" last="Salin">Laurence Salin</name>
<affiliation><inist:fA14 i1="04"><s1>Medical and Drug Regulatory Affairs, Boehringer Ingelheim</s1>
<s2>Reims</s2>
<s3>FRA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Juhel, Nolwenn" sort="Juhel, Nolwenn" uniqKey="Juhel N" first="Nolwenn" last="Juhel">Nolwenn Juhel</name>
<affiliation><inist:fA14 i1="04"><s1>Medical and Drug Regulatory Affairs, Boehringer Ingelheim</s1>
<s2>Reims</s2>
<s3>FRA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Waldhauser, Lisa" sort="Waldhauser, Lisa" uniqKey="Waldhauser L" first="Lisa" last="Waldhauser">Lisa Waldhauser</name>
<affiliation><inist:fA14 i1="05"><s1>Clinical Research, Boehringer Ingelheim</s1>
<s2>Biberach</s2>
<s3>DEU</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
<author><name sortKey="Schindler, Thomas" sort="Schindler, Thomas" uniqKey="Schindler T" first="Thomas" last="Schindler">Thomas Schindler</name>
<affiliation><inist:fA14 i1="05"><s1>Clinical Research, Boehringer Ingelheim</s1>
<s2>Biberach</s2>
<s3>DEU</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</inist:fA14>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Archives of neurology : (Chicago)</title>
<title level="j" type="abbreviated">Arch. neurol. : (Chic.)</title>
<idno type="ISSN">0003-9942</idno>
<imprint><date when="2008">2008</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Archives of neurology : (Chicago)</title>
<title level="j" type="abbreviated">Arch. neurol. : (Chic.)</title>
<idno type="ISSN">0003-9942</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term>
<term>Fluctuations</term>
<term>Human</term>
<term>Nervous system diseases</term>
<term>Parkinson disease</term>
<term>Reuptake inhibitor</term>
<term>Tesofensine</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term>
<term>Pathologie du   système nerveux</term>
<term>Tésofensine</term>
<term>Inhibiteur recapture</term>
<term>Homme</term>
<term>Stade avancé</term>
<term>Fluctuation</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Objective: To assess the safety and efficacy of tesofensine, a triple monoamine reuptake inhibitor, in patients with advanced Parkinson disease (PD). Design: A pilot phase 2, randomized, double-blind, placebo-controlled, parallel-group trial. The study occurred in hospital-based outpatient clinics and in clinical trial units. Patients with advanced PD and levodoparelated motor fluctuations were enrolled. Tesofensine (0.125, 0.25, 0.5, or 1 mg) or placebo tablets were administered once daily for 14 weeks. Main Outcome Measures: Coprimary end points were the changes from baseline in Unified Parkinson Disease Rating Scale (UPDRS) subscale II (activities of daily living) plus subscale III (motor function) total score and in percentage of waking hours spent in "off" time noted in self-scoring diaries. Secondary end points were safety, pharmacokinetics, responder analysis (≥20% reduction in UPDRS score and in off time), and changes in percentage of waking hours spent in "on" time with and without troublesome dyskinesia. Results: The adjusted mean differences (relative to placebo) were -4.7 points in UPDRS subscale II plus subscale III total score (P=.005) with tesofensine, 0.5 mg, and -7.1% in off time (-68 minutes, P=.02) with tesofensine, 0.25 mg. Other dosages did not induce statistically significant effects. The plasma concentration increased with the dosage, but no clear dose-response relationship was observed. Gastrointestinal tract and neuropsychiatric adverse events were more frequent with tesofensine than with placebo, especially at the higher dosages. Conclusions: Patients with PD in advanced stages showed modest improvements in UPDRS subscale II plus subscale III total score and in off time when treated with tesofensine, but a dose-response relationship could not be established for efficacy, while adverse drug reactions tended to be more frequent at higher dosages.</div>
</front>
</TEI>
<inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0003-9942</s0>
</fA01>
<fA02 i1="01"><s0>ARNEAS</s0>
</fA02>
<fA03 i2="1"><s0>Arch. neurol. : (Chic.)</s0>
</fA03>
<fA05><s2>65</s2>
</fA05>
<fA06><s2>5</s2>
</fA06>
<fA08 i1="01" i2="1" l="ENG"><s1>Tesofensine (NS 2330), a Monoamine Reuptake Inhibitor, in Patients With Advanced Parkinson Disease and Motor Fluctuations : The ADVANS Study</s1>
</fA08>
<fA11 i1="01" i2="1"><s1>RASCOL (Olivier)</s1>
</fA11>
<fA11 i1="02" i2="1"><s1>POEWE (Werner)</s1>
</fA11>
<fA11 i1="03" i2="1"><s1>LEES (Andrew)</s1>
</fA11>
<fA11 i1="04" i2="1"><s1>ARISTIN (Marina)</s1>
</fA11>
<fA11 i1="05" i2="1"><s1>SALIN (Laurence)</s1>
</fA11>
<fA11 i1="06" i2="1"><s1>JUHEL (Nolwenn)</s1>
</fA11>
<fA11 i1="07" i2="1"><s1>WALDHAUSER (Lisa)</s1>
</fA11>
<fA11 i1="08" i2="1"><s1>SCHINDLER (Thomas)</s1>
</fA11>
<fA14 i1="01"><s1>Laboratoire de Pharmacologie Médicale et Clinique, Pôle Neurosciences, Centre d'Investigations Cliniques, Institut National de la Santé et de la Récherche Médicale, Unité 825, University Hospital</s1>
<s2>Toulouse</s2>
<s3>FRA</s3>
<sZ>1 aut.</sZ>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="02"><s1>Department of Neurology, Universitätskliniken</s1>
<s2>Innsbruck</s2>
<s3>AUT</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Reta Lila Weston Institute for Neurological Studies, Institute ofNeurology, University College London</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Medical and Drug Regulatory Affairs, Boehringer Ingelheim</s1>
<s2>Reims</s2>
<s3>FRA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Clinical Research, Boehringer Ingelheim</s1>
<s2>Biberach</s2>
<s3>DEU</s3>
<sZ>7 aut.</sZ>
<sZ>8 aut.</sZ>
</fA14>
<fA17 i1="01" i2="1"><s1>ADVANS Study Group</s1>
<s3>INC</s3>
</fA17>
<fA20><s1>577-583</s1>
</fA20>
<fA21><s1>2008</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
<fA43 i1="01"><s1>INIST</s1>
<s2>2048B</s2>
<s5>354000195879560010</s5>
</fA43>
<fA44><s0>0000</s0>
<s1>© 2008 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>16 ref.</s0>
</fA45>
<fA47 i1="01" i2="1"><s0>08-0248382</s0>
</fA47>
<fA60><s1>P</s1>
</fA60>
<fA61><s0>A</s0>
</fA61>
<fA64 i1="01" i2="1"><s0>Archives of neurology : (Chicago)</s0>
</fA64>
<fA66 i1="01"><s0>USA</s0>
</fA66>
<fC01 i1="01" l="ENG"><s0>Objective: To assess the safety and efficacy of tesofensine, a triple monoamine reuptake inhibitor, in patients with advanced Parkinson disease (PD). Design: A pilot phase 2, randomized, double-blind, placebo-controlled, parallel-group trial. The study occurred in hospital-based outpatient clinics and in clinical trial units. Patients with advanced PD and levodoparelated motor fluctuations were enrolled. Tesofensine (0.125, 0.25, 0.5, or 1 mg) or placebo tablets were administered once daily for 14 weeks. Main Outcome Measures: Coprimary end points were the changes from baseline in Unified Parkinson Disease Rating Scale (UPDRS) subscale II (activities of daily living) plus subscale III (motor function) total score and in percentage of waking hours spent in "off" time noted in self-scoring diaries. Secondary end points were safety, pharmacokinetics, responder analysis (≥20% reduction in UPDRS score and in off time), and changes in percentage of waking hours spent in "on" time with and without troublesome dyskinesia. Results: The adjusted mean differences (relative to placebo) were -4.7 points in UPDRS subscale II plus subscale III total score (P=.005) with tesofensine, 0.5 mg, and -7.1% in off time (-68 minutes, P=.02) with tesofensine, 0.25 mg. Other dosages did not induce statistically significant effects. The plasma concentration increased with the dosage, but no clear dose-response relationship was observed. Gastrointestinal tract and neuropsychiatric adverse events were more frequent with tesofensine than with placebo, especially at the higher dosages. Conclusions: Patients with PD in advanced stages showed modest improvements in UPDRS subscale II plus subscale III total score and in off time when treated with tesofensine, but a dose-response relationship could not be established for efficacy, while adverse drug reactions tended to be more frequent at higher dosages.</s0>
</fC01>
<fC02 i1="01" i2="X"><s0>002B17</s0>
</fC02>
<fC02 i1="02" i2="X"><s0>002B17G</s0>
</fC02>
<fC03 i1="01" i2="X" l="FRE"><s0>Maladie de Parkinson</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="ENG"><s0>Parkinson disease</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="01" i2="X" l="SPA"><s0>Parkinson enfermedad</s0>
<s2>NM</s2>
<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Pathologie du   système nerveux</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="ENG"><s0>Nervous system diseases</s0>
<s5>02</s5>
</fC03>
<fC03 i1="02" i2="X" l="SPA"><s0>Sistema nervioso patología</s0>
<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Tésofensine</s0>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Tesofensine</s0>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Tesofensina</s0>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Inhibiteur recapture</s0>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Reuptake inhibitor</s0>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA"><s0>Inhibidor recaptura</s0>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE"><s0>Homme</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Human</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Hombre</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Stade avancé</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Advanced stage</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Estadio avanzado</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Fluctuation</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Fluctuations</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Fluctuación</s0>
<s5>13</s5>
</fC03>
<fC07 i1="01" i2="X" l="FRE"><s0>Pathologie de l'encéphale</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>Syndrome extrapyramidal</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="ENG"><s0>Extrapyramidal syndrome</s0>
<s5>38</s5>
</fC07>
<fC07 i1="02" i2="X" l="SPA"><s0>Extrapiramidal síndrome</s0>
<s5>38</s5>
</fC07>
<fC07 i1="03" i2="X" l="FRE"><s0>Maladie dégénérative</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="ENG"><s0>Degenerative disease</s0>
<s5>39</s5>
</fC07>
<fC07 i1="03" i2="X" l="SPA"><s0>Enfermedad degenerativa</s0>
<s5>39</s5>
</fC07>
<fC07 i1="04" i2="X" l="FRE"><s0>Pathologie du   système nerveux central</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="ENG"><s0>Central nervous system disease</s0>
<s5>40</s5>
</fC07>
<fC07 i1="04" i2="X" l="SPA"><s0>Sistema nervosio central patología</s0>
<s5>40</s5>
</fC07>
<fN21><s1>162</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
<server><NO>PASCAL 08-0248382 INIST</NO>
<ET>Tesofensine (NS 2330), a Monoamine Reuptake Inhibitor, in Patients With Advanced Parkinson Disease and Motor Fluctuations : The ADVANS Study</ET>
<AU>RASCOL (Olivier); POEWE (Werner); LEES (Andrew); ARISTIN (Marina); SALIN (Laurence); JUHEL (Nolwenn); WALDHAUSER (Lisa); SCHINDLER (Thomas)</AU>
<AF>Laboratoire de Pharmacologie Médicale et Clinique, Pôle Neurosciences, Centre d'Investigations Cliniques, Institut National de la Santé et de la Récherche Médicale, Unité 825, University Hospital/Toulouse/France (1 aut., 4 aut.); Department of Neurology, Universitätskliniken/Innsbruck/Autriche (2 aut.); Reta Lila Weston Institute for Neurological Studies, Institute ofNeurology, University College London/London/Royaume-Uni (3 aut.); Medical and Drug Regulatory Affairs, Boehringer Ingelheim/Reims/France (5 aut., 6 aut.); Clinical Research, Boehringer Ingelheim/Biberach/Allemagne (7 aut., 8 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Archives of neurology : (Chicago); ISSN 0003-9942; Coden ARNEAS; Etats-Unis; Da. 2008; Vol. 65; No. 5; Pp. 577-583; Bibl. 16 ref.</SO>
<LA>Anglais</LA>
<EA>Objective: To assess the safety and efficacy of tesofensine, a triple monoamine reuptake inhibitor, in patients with advanced Parkinson disease (PD). Design: A pilot phase 2, randomized, double-blind, placebo-controlled, parallel-group trial. The study occurred in hospital-based outpatient clinics and in clinical trial units. Patients with advanced PD and levodoparelated motor fluctuations were enrolled. Tesofensine (0.125, 0.25, 0.5, or 1 mg) or placebo tablets were administered once daily for 14 weeks. Main Outcome Measures: Coprimary end points were the changes from baseline in Unified Parkinson Disease Rating Scale (UPDRS) subscale II (activities of daily living) plus subscale III (motor function) total score and in percentage of waking hours spent in "off" time noted in self-scoring diaries. Secondary end points were safety, pharmacokinetics, responder analysis (≥20% reduction in UPDRS score and in off time), and changes in percentage of waking hours spent in "on" time with and without troublesome dyskinesia. Results: The adjusted mean differences (relative to placebo) were -4.7 points in UPDRS subscale II plus subscale III total score (P=.005) with tesofensine, 0.5 mg, and -7.1% in off time (-68 minutes, P=.02) with tesofensine, 0.25 mg. Other dosages did not induce statistically significant effects. The plasma concentration increased with the dosage, but no clear dose-response relationship was observed. Gastrointestinal tract and neuropsychiatric adverse events were more frequent with tesofensine than with placebo, especially at the higher dosages. Conclusions: Patients with PD in advanced stages showed modest improvements in UPDRS subscale II plus subscale III total score and in off time when treated with tesofensine, but a dose-response relationship could not be established for efficacy, while adverse drug reactions tended to be more frequent at higher dosages.</EA>
<CC>002B17; 002B17G</CC>
<FD>Maladie de Parkinson; Pathologie du   système nerveux; Tésofensine; Inhibiteur recapture; Homme; Stade avancé; Fluctuation</FD>
<FG>Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du   système nerveux central</FG>
<ED>Parkinson disease; Nervous system diseases; Tesofensine; Reuptake inhibitor; Human; Advanced stage; Fluctuations</ED>
<EG>Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease</EG>
<SD>Parkinson enfermedad; Sistema nervioso patología; Tesofensina; Inhibidor recaptura; Hombre; Estadio avanzado; Fluctuación</SD>
<LO>INIST-2048B.354000195879560010</LO>
<ID>08-0248382</ID>
</server>
</inist>
</record>

Pour manipuler ce document sous Unix (Dilib)

EXPLOR_STEP=$WICRI_ROOT/Wicri/Sante/explor/ParkinsonFranceV1/Data/PascalFrancis/Corpus

HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000897 | SxmlIndent | more

HfdSelect -h $EXPLOR_AREA/Data/PascalFrancis/Corpus/biblio.hfd -nk 000897 | SxmlIndent | more

Pour mettre un lien sur cette page dans le réseau Wicri

{{Explor lien
   |wiki=    Wicri/Sante
   |area=    ParkinsonFranceV1
   |flux=    PascalFrancis
   |étape=   Corpus
   |type=    RBID
   |clé=     Pascal:08-0248382
   |texte=   Tesofensine (NS 2330), a Monoamine Reuptake Inhibitor, in Patients With Advanced Parkinson Disease and Motor Fluctuations : The ADVANS Study
}}

This area was generated with Dilib version V0.6.29.
Data generation: Wed May 17 19:46:39 2017. Site generation: Mon Mar 4 15:48:15 2024

	La maladie de Parkinson en France (serveur d'exploration)
	Attention, ce site est en cours de développement ! Attention, site généré par des moyens informatiques à partir de corpus bruts. Les informations ne sont donc pas validées.

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

Tesofensine (NS 2330), a Monoamine Reuptake Inhibitor, in Patients With Advanced Parkinson Disease and Motor Fluctuations : The ADVANS Study

Tesofensine (NS 2330), a Monoamine Reuptake Inhibitor, in Patients With Advanced Parkinson Disease and Motor Fluctuations : The ADVANS Study

Source :

Descripteurs français

English descriptors

Abstract

Notice en format standard (ISO 2709)

Format Inist (serveur)

Links to Exploration step

Le document en format XML

Pour manipuler ce document sous Unix (Dilib)

Pour mettre un lien sur cette page dans le réseau Wicri