MovDisordV3, PascalFrancis, Curation, bibRecord, 001489

Placebo-controlled, double-blind dose-finding study of entacapone in fluctuating Parkinsonian patients

Identifieur interne : 001489 ( PascalFrancis/Curation ); précédent : 001488; suivant : 001490

Placebo-controlled, double-blind dose-finding study of entacapone in fluctuating Parkinsonian patients

Auteurs : Yoshikuni Mizuno [Japon] ; Ichiro Kanazawa [Japon] ; Sadako Kuno [Japon] ; Nobuo Yanagisawa [Japon] ; Mitsutoshi Yamamoto [Japon] ; Tomoyoshi Kondo [Japon]

Source :

Movement disorders [ 0885-3185 ] ; 2007.

RBID : Pascal:07-0133220

Descripteurs français

Pascal (Inist)
- Système nerveux pathologie, Parkinson maladie, Placebo, Etude double insu, Entacapone, Homme, Traitement, Fluctuation.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Double blind study, Entacapone, Fluctuations, Human, Nervous system diseases, Parkinson disease, Placebo, Treatment.

Abstract

We conducted a multicenter randomized, placebo-controlled double-blind parallel-group study in Japanese Parkinson' disease (PD) patients with wearing-off motor fluctuations to determine the clinical efficacy and safety of entacapone as an adjunct to concomitant treatment with levodopa and a dopa decarboxylase inhibitor (DCI). We randomized 341 patients to receive entacapone 100 or 200 mg or placebo per dose of levodopa/DCI for 8 weeks. The primary efficacy variable was on time change while awake, determined by patients' diaries. Mean baseline on time in each group was approximately 8 hours. Mean on time change at final assessment was 1.4 hours each for entacapone 100-mg and 200-mg groups and by 0.5 hours for the placebo group (P < 0.05). The two entacapone doses were equally efficacious. Adverse events occurred in 79 patients (69.9%) in placebo, 82 (72.6%) in 100 mg, and 98 (86.0%) in 200 mg. The most common adverse event with entacapone was an increase in dyskinesias. The overall safety profile was satisfactory in both entacapone groups. In conclusion, both entacapone 100 and 200 mg were equally effective in increasing on time of PD patients with wearing-off fluctuations, although the safety and tolerability profile appeared more favorable for the 100-mg dose.

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A08	`01`	`1`	`ENG`	`@1 Placebo-controlled, double-blind dose-finding study of entacapone in fluctuating Parkinsonian patients`
A11	`01`	`1`		`@1 MIZUNO (Yoshikuni)`
A11	`02`	`1`		`@1 KANAZAWA (Ichiro)`
A11	`03`	`1`		`@1 KUNO (Sadako)`
A11	`04`	`1`		`@1 YANAGISAWA (Nobuo)`
A11	`05`	`1`		`@1 YAMAMOTO (Mitsutoshi)`
A11	`06`	`1`		`@1 KONDO (Tomoyoshi)`
A14	`01`			`@1 Department of Neurology, Juntendo University School of Medicine @2 Tokyo @3 JPN @Z 1 aut.`
A14	`02`			`@1 National Center of Neurology and Psychiatry @2 Tokyo @3 JPN @Z 2 aut. @Z 3 aut.`
A14	`03`			`@1 Kanto Rosai Hospital @2 Kanagawa @3 JPN @Z 4 aut.`
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A17	`01`	`1`		`@1 the Japanese Parkinson-Entacapone Study Group @3 JPN`
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C01	`01`		`ENG`	@0 We conducted a multicenter randomized, placebo-controlled double-blind parallel-group study in Japanese Parkinson' disease (PD) patients with wearing-off motor fluctuations to determine the clinical efficacy and safety of entacapone as an adjunct to concomitant treatment with levodopa and a dopa decarboxylase inhibitor (DCI). We randomized 341 patients to receive entacapone 100 or 200 mg or placebo per dose of levodopa/DCI for 8 weeks. The primary efficacy variable was on time change while awake, determined by patients' diaries. Mean baseline on time in each group was approximately 8 hours. Mean on time change at final assessment was 1.4 hours each for entacapone 100-mg and 200-mg groups and by 0.5 hours for the placebo group (P < 0.05). The two entacapone doses were equally efficacious. Adverse events occurred in 79 patients (69.9%) in placebo, 82 (72.6%) in 100 mg, and 98 (86.0%) in 200 mg. The most common adverse event with entacapone was an increase in dyskinesias. The overall safety profile was satisfactory in both entacapone groups. In conclusion, both entacapone 100 and 200 mg were equally effective in increasing on time of PD patients with wearing-off fluctuations, although the safety and tolerability profile appeared more favorable for the 100-mg dose.
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C03	`04`	`X`	`FRE`	`@0 Etude double insu @5 10`
C03	`04`	`X`	`ENG`	`@0 Double blind study @5 10`
C03	`04`	`X`	`SPA`	`@0 Estudio doble ciego @5 10`
C03	`05`	`X`	`FRE`	`@0 Entacapone @2 NK @2 FR @5 11`
C03	`05`	`X`	`ENG`	`@0 Entacapone @2 NK @2 FR @5 11`
C03	`05`	`X`	`SPA`	`@0 Entacapona @2 NK @2 FR @5 11`
C03	`06`	`X`	`FRE`	`@0 Homme @5 12`
C03	`06`	`X`	`ENG`	`@0 Human @5 12`
C03	`06`	`X`	`SPA`	`@0 Hombre @5 12`
C03	`07`	`X`	`FRE`	`@0 Traitement @5 13`
C03	`07`	`X`	`ENG`	`@0 Treatment @5 13`
C03	`07`	`X`	`SPA`	`@0 Tratamiento @5 13`
C03	`08`	`X`	`FRE`	`@0 Fluctuation @5 14`
C03	`08`	`X`	`ENG`	`@0 Fluctuations @5 14`
C03	`08`	`X`	`SPA`	`@0 Fluctuación @5 14`
C07	`01`	`X`	`FRE`	`@0 Encéphale pathologie @5 37`
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C07	`02`	`X`	`SPA`	`@0 Extrapiramidal síndrome @5 38`
C07	`03`	`X`	`FRE`	`@0 Maladie dégénérative @5 39`
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N44	`01`			`@1 OTO`
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Le document en format XML

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<front><div type="abstract" xml:lang="en">We conducted a multicenter randomized, placebo-controlled double-blind parallel-group study in Japanese Parkinson' disease (PD) patients with wearing-off motor fluctuations to determine the clinical efficacy and safety of entacapone as an adjunct to concomitant treatment with levodopa and a dopa decarboxylase inhibitor (DCI). We randomized 341 patients to receive entacapone 100 or 200 mg or placebo per dose of levodopa/DCI for 8 weeks. The primary efficacy variable was on time change while awake, determined by patients' diaries. Mean baseline on time in each group was approximately 8 hours. Mean on time change at final assessment was 1.4 hours each for entacapone 100-mg and 200-mg groups and by 0.5 hours for the placebo group (P < 0.05). The two entacapone doses were equally efficacious. Adverse events occurred in 79 patients (69.9%) in placebo, 82 (72.6%) in 100 mg, and 98 (86.0%) in 200 mg. The most common adverse event with entacapone was an increase in dyskinesias. The overall safety profile was satisfactory in both entacapone groups. In conclusion, both entacapone 100 and 200 mg were equally effective in increasing on time of PD patients with wearing-off fluctuations, although the safety and tolerability profile appeared more favorable for the 100-mg dose.</div>
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<fC03 i1="05" i2="X" l="FRE"><s0>Entacapone</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="ENG"><s0>Entacapone</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>11</s5>
</fC03>
<fC03 i1="05" i2="X" l="SPA"><s0>Entacapona</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>11</s5>
</fC03>
<fC03 i1="06" i2="X" l="FRE"><s0>Homme</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="ENG"><s0>Human</s0>
<s5>12</s5>
</fC03>
<fC03 i1="06" i2="X" l="SPA"><s0>Hombre</s0>
<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Traitement</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Treatment</s0>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Tratamiento</s0>
<s5>13</s5>
</fC03>
<fC03 i1="08" i2="X" l="FRE"><s0>Fluctuation</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="ENG"><s0>Fluctuations</s0>
<s5>14</s5>
</fC03>
<fC03 i1="08" i2="X" l="SPA"><s0>Fluctuación</s0>
<s5>14</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>Extrapyramidal syndrome</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>Système nerveux central pathologie</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>085</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
</fN82>
</pA>
</standard>
</inist>
</record>

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	Movement Disorders (revue)
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Movement Disorders (revue)

Placebo-controlled, double-blind dose-finding study of entacapone in fluctuating Parkinsonian patients

Placebo-controlled, double-blind dose-finding study of entacapone in fluctuating Parkinsonian patients

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