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 : 000898Tesofensine (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 SchindlerSource :
- Archives of neurology : (Chicago) [ 0003-9942 ] ; 2008.
Descripteurs français
- Pascal (Inist)
English descriptors
- KwdEn :
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.
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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 |
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Pascal:08-0248382Le document en format XML
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<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>
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<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>
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