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Movement Disorders (revue)

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Melevodopa/Carbidopa Effervescent Formulation in the Treatment of Motor Fluctuations in Advanced Parkinson's Disease

Identifieur interne : 002401 ( PascalFrancis/Curation ); précédent : 002400; suivant : 002402

Melevodopa/Carbidopa Effervescent Formulation in the Treatment of Motor Fluctuations in Advanced Parkinson's Disease

Auteurs : Fabrizio Stocchi [Italie] ; Mario Zappia [Italie] ; Valentina Dall'Armi [Italie] ; Jaime Kulisevsky [Espagne] ; Paolo Lamberti [Italie] ; José Angel Obeso [Espagne]

Source :

RBID : Pascal:10-0446313

Descripteurs français

English descriptors

Abstract

Melevodopa hydrochloride plus carbidopa in effervescent tablets (M/C) is a readily soluble antiparkinsonian tablet formulation. A total of 221 patients with Parkinson's disease and motor fluctuations entered a randomized, double-blind, double-dummy, controlled parallel group study, which compared the effectiveness of oral M/C effervescent tablets with standard oral formulation levodopa/carbidopa tablets (L/C; Sinemet) in reducing total daily OFF time. The difference of total daily OFF time (intention-to-treat population) between the two groups was not statistically significant (P = 0.07): -39.4 minutes (95%CI: -67.08 to - 11.73) in M/C group vs. +3.5 minutes (95%CI: -36.19 to +43.26) in the L/C group. In the intragroup analysis, M/C significantly reduced the baseline daily OFF, which remained unchanged in the L/C group. There were no unexpected adverse events in either treatment arms, and discontinuation rates due to adverse events did not differ between the two groups [M/C: 2 patients (1.3%); L/C: 1 patient (1.4°70)]. This study failed to meet the primary endpoint (P = 0.07); however, there was a trend in favour of the M/C preparation, which deserves further attention.
pA  
A01 01  1    @0 0885-3185
A03   1    @0 Mov. disord.
A05       @2 25
A06       @2 12
A08 01  1  ENG  @1 Melevodopa/Carbidopa Effervescent Formulation in the Treatment of Motor Fluctuations in Advanced Parkinson's Disease
A11 01  1    @1 STOCCHI (Fabrizio)
A11 02  1    @1 ZAPPIA (Mario)
A11 03  1    @1 DALL'ARMI (Valentina)
A11 04  1    @1 KULISEVSKY (Jaime)
A11 05  1    @1 LAMBERTI (Paolo)
A11 06  1    @1 ANGEL OBESO (José)
A14 01      @1 Department of Neuroscience, Institute of Neurology, IRCCS San Raffaele Pisana @2 Roma 00163 @3 ITA @Z 1 aut.
A14 02      @1 Neuroscience Department, University of Catania @2 Catania 95123 @3 ITA @Z 2 aut.
A14 03      @1 Department of Clinical and Molecular Epidemiology, IRCCS San Raffaele Pisana @2 Roma 00163 @3 ITA @Z 3 aut.
A14 04      @1 Neurology Department, Movement Disorder Unit, Fundació de G. S. de l'Hospital de la Santa Creu Sant Pau @2 Barcelona @3 ESP @Z 4 aut.
A14 05      @1 Department of Neurology, Ospedale Policlinico Consorziale @2 Bari 70124 @3 ITA @Z 5 aut.
A14 06      @1 Department of Neurology, Neurology, Clinica Universitaria de Navarra @2 Pamplona 31008 @3 ESP @Z 6 aut.
A17 01  1    @1 Melevodopa Plus Carbidopa Study Group @3 INC
A20       @1 1881-1887
A21       @1 2010
A23 01      @0 ENG
A43 01      @1 INIST @2 20953 @5 354000194841700150
A44       @0 0000 @1 © 2010 INIST-CNRS. All rights reserved.
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A47 01  1    @0 10-0446313
A60       @1 P
A61       @0 A
A64 01  1    @0 Movement disorders
A66 01      @0 USA
C01 01    ENG  @0 Melevodopa hydrochloride plus carbidopa in effervescent tablets (M/C) is a readily soluble antiparkinsonian tablet formulation. A total of 221 patients with Parkinson's disease and motor fluctuations entered a randomized, double-blind, double-dummy, controlled parallel group study, which compared the effectiveness of oral M/C effervescent tablets with standard oral formulation levodopa/carbidopa tablets (L/C; Sinemet) in reducing total daily OFF time. The difference of total daily OFF time (intention-to-treat population) between the two groups was not statistically significant (P = 0.07): -39.4 minutes (95%CI: -67.08 to - 11.73) in M/C group vs. +3.5 minutes (95%CI: -36.19 to +43.26) in the L/C group. In the intragroup analysis, M/C significantly reduced the baseline daily OFF, which remained unchanged in the L/C group. There were no unexpected adverse events in either treatment arms, and discontinuation rates due to adverse events did not differ between the two groups [M/C: 2 patients (1.3%); L/C: 1 patient (1.4°70)]. This study failed to meet the primary endpoint (P = 0.07); however, there was a trend in favour of the M/C preparation, which deserves further attention.
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 Mélévodopa @2 NK @2 FR @5 09
C03 03  X  ENG  @0 Melevodopa @2 NK @2 FR @5 09
C03 03  X  SPA  @0 Melevodopa @2 NK @2 FR @5 09
C03 04  X  FRE  @0 Carbidopa @2 NK @2 FR @5 10
C03 04  X  ENG  @0 Carbidopa @2 NK @2 FR @5 10
C03 04  X  SPA  @0 Carbidopa @2 NK @2 FR @5 10
C03 05  X  FRE  @0 Formulation @5 11
C03 05  X  ENG  @0 Formulation @5 11
C03 05  X  SPA  @0 Formulación @5 11
C03 06  X  FRE  @0 Traitement @5 12
C03 06  X  ENG  @0 Treatment @5 12
C03 06  X  SPA  @0 Tratamiento @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
C03 08  X  FRE  @0 Stade avancé @5 14
C03 08  X  ENG  @0 Advanced stage @5 14
C03 08  X  SPA  @0 Estadio avanzado @5 14
C03 09  X  FRE  @0 Lévodopa @2 NK @2 FR @5 15
C03 09  X  ENG  @0 Levodopa @2 NK @2 FR @5 15
C03 09  X  SPA  @0 Levodopa @2 NK @2 FR @5 15
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       @1 291
N44 01      @1 OTO
N82       @1 OTO

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Pascal:10-0446313

Le document en format XML

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<div type="abstract" xml:lang="en">Melevodopa hydrochloride plus carbidopa in effervescent tablets (M/C) is a readily soluble antiparkinsonian tablet formulation. A total of 221 patients with Parkinson's disease and motor fluctuations entered a randomized, double-blind, double-dummy, controlled parallel group study, which compared the effectiveness of oral M/C effervescent tablets with standard oral formulation levodopa/carbidopa tablets (L/C; Sinemet) in reducing total daily OFF time. The difference of total daily OFF time (intention-to-treat population) between the two groups was not statistically significant (P = 0.07): -39.4 minutes (95%CI: -67.08 to - 11.73) in M/C group vs. +3.5 minutes (95%CI: -36.19 to +43.26) in the L/C group. In the intragroup analysis, M/C significantly reduced the baseline daily OFF, which remained unchanged in the L/C group. There were no unexpected adverse events in either treatment arms, and discontinuation rates due to adverse events did not differ between the two groups [M/C: 2 patients (1.3%); L/C: 1 patient (1.4°70)]. This study failed to meet the primary endpoint (P = 0.07); however, there was a trend in favour of the M/C preparation, which deserves further attention.</div>
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<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG">
<s0>Melevodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA">
<s0>Melevodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE">
<s0>Carbidopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG">
<s0>Carbidopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="SPA">
<s0>Carbidopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="05" i2="X" l="FRE">
<s0>Formulation</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG">
<s0>Formulation</s0>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA">
<s0>Formulación</s0>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE">
<s0>Traitement</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG">
<s0>Treatment</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA">
<s0>Tratamiento</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>
<fC03 i1="08" i2="X" l="FRE">
<s0>Stade avancé</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG">
<s0>Advanced stage</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA">
<s0>Estadio avanzado</s0>
<s5>14</s5>
</fC03>
<fC03 i1="09" i2="X" l="FRE">
<s0>Lévodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>15</s5>
</fC03>
<fC03 i1="09" i2="X" l="ENG">
<s0>Levodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>15</s5>
</fC03>
<fC03 i1="09" i2="X" l="SPA">
<s0>Levodopa</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>15</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>291</s1>
</fN21>
<fN44 i1="01">
<s1>OTO</s1>
</fN44>
<fN82>
<s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>

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