MovDisordV3, PascalFrancis, Corpus, bibRecord, 000303

A Randomized, Double-Blind, Placebo-Controlled Trial of Safinamide as Add-on Therapy in Early Parkinson's Disease Patients

Identifieur interne : 000303 ( PascalFrancis/Corpus ); précédent : 000302; suivant : 000304

A Randomized, Double-Blind, Placebo-Controlled Trial of Safinamide as Add-on Therapy in Early Parkinson's Disease Patients

Auteurs : Fabrizio Stocchi ; Rupam Borgohain ; Marco Onofrj ; Anthony H. V. Schapira ; Mohit Bhatt ; Valentina Lucini ; Rodolfo Giuliani ; Ravi Anand

Source :

Movement disorders [ 0885-3185 ] ; 2012.

RBID : Pascal:12-0106491

Descripteurs français

Pascal (Inist)
- Maladie de Parkinson, Pathologie du système nerveux, Placebo, Safinamide, Traitement, Homme, Dopamine.

English descriptors

KwdEn :
- Dopamine, Human, Nervous system diseases, Parkinson disease, Placebo, Safinamide, Treatment.

Abstract

Safinamide is an α-aminoamide with both dopaminergic and nondopaminergic mechanisms of action evaluated as an add-on to dopamine agonist (DA) therapy in early-stage PD. In this 24-week, double-blind study, patients with early PD receiving a stable dose of a single DA were randomized to once-daily safinamide 100 mg, safinamide 200 mg, or placebo. The primary efficacy variable was UPDRS part III (motor examination) total score. Analysis was hierarchical: 200 mg of safinamide versus placebo was tested first; the success of safinamide 100 mg versus placebo was contingent on this. Two hundred sixty-nine patients received safinamide 100 mg (n = 90), safinamide 200 mg (n = 89), or placebo (n = 90); 70, 81, and 81 patients, respectively, completed the study. Mean improvements from baseline to week 24 in UPDRS III total scores were -3.90 for safinamide 200 mg, -6.0 for safinamide 100 mg and -3.60 for placebo. The difference between safinamide 200 mg and placebo was not significant [point estimate: -0.4; 95% confidence interval (CI): -2.3-1.4; P = 0.6504]. Although the difference between 100 mg/day and placebo was significant (point estimate: -1.9; 95% CI: -3.7 to -0.1; P = 0.0419), these results are considered exploratory. No clinically meaningful differences from placebo were observed for any safety variables. This study did not demonstrate a significant improvement of the primary endpoint for safinamide 200 mg/day. Exploratory analysis of the primary endpoint for 100 mg/day demonstrated that the addition of safinamide to a stable dose of DA improves motor symptoms in early PD and warrants further investigation.

Notice en format standard (ISO 2709)

Pour connaître la documentation sur le format Inist Standard.

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C01	`01`		`ENG`	@0 Safinamide is an α-aminoamide with both dopaminergic and nondopaminergic mechanisms of action evaluated as an add-on to dopamine agonist (DA) therapy in early-stage PD. In this 24-week, double-blind study, patients with early PD receiving a stable dose of a single DA were randomized to once-daily safinamide 100 mg, safinamide 200 mg, or placebo. The primary efficacy variable was UPDRS part III (motor examination) total score. Analysis was hierarchical: 200 mg of safinamide versus placebo was tested first; the success of safinamide 100 mg versus placebo was contingent on this. Two hundred sixty-nine patients received safinamide 100 mg (n = 90), safinamide 200 mg (n = 89), or placebo (n = 90); 70, 81, and 81 patients, respectively, completed the study. Mean improvements from baseline to week 24 in UPDRS III total scores were -3.90 for safinamide 200 mg, -6.0 for safinamide 100 mg and -3.60 for placebo. The difference between safinamide 200 mg and placebo was not significant [point estimate: -0.4; 95% confidence interval (CI): -2.3-1.4; P = 0.6504]. Although the difference between 100 mg/day and placebo was significant (point estimate: -1.9; 95% CI: -3.7 to -0.1; P = 0.0419), these results are considered exploratory. No clinically meaningful differences from placebo were observed for any safety variables. This study did not demonstrate a significant improvement of the primary endpoint for safinamide 200 mg/day. Exploratory analysis of the primary endpoint for 100 mg/day demonstrated that the addition of safinamide to a stable dose of DA improves motor symptoms in early PD and warrants further investigation.
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Format Inist (serveur)

NO :	PASCAL 12-0106491 INIST
ET :	A Randomized, Double-Blind, Placebo-Controlled Trial of Safinamide as Add-on Therapy in Early Parkinson's Disease Patients
AU :	STOCCHI (Fabrizio); BORGOHAIN (Rupam); ONOFRJ (Marco); SCHAPIRA (Anthony H. V.); BHATT (Mohit); LUCINI (Valentina); GIULIANI (Rodolfo); ANAND (Ravi)
AF :	Department of Neuroscience, IRCCS San Raffaele/Rome/Italie (1 aut.); Department of Neurology, Nizam's Institute of Medical Sciences/Hyderabad/Inde (2 aut.); Department of Neurology, Chieti-Pescara University/Chieti/Italie (3 aut.); Department of Clinical Neurosciences, UCL Institute of Neurology/London/Royaume-Uni (4 aut.); Movement Disorder Clinic/Mumbai/Inde (5 aut.); Development Department, Newron Pharmaceuticals/Milan/Italie (6 aut., 7 aut.); APC/St. Moritz/Suisse (8 aut.)
DT :	Publication en série; Niveau analytique
SO :	Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2012; Vol. 27; No. 1; Pp. 106-112; Bibl. 20 ref.
LA :	Anglais
EA :	Safinamide is an α-aminoamide with both dopaminergic and nondopaminergic mechanisms of action evaluated as an add-on to dopamine agonist (DA) therapy in early-stage PD. In this 24-week, double-blind study, patients with early PD receiving a stable dose of a single DA were randomized to once-daily safinamide 100 mg, safinamide 200 mg, or placebo. The primary efficacy variable was UPDRS part III (motor examination) total score. Analysis was hierarchical: 200 mg of safinamide versus placebo was tested first; the success of safinamide 100 mg versus placebo was contingent on this. Two hundred sixty-nine patients received safinamide 100 mg (n = 90), safinamide 200 mg (n = 89), or placebo (n = 90); 70, 81, and 81 patients, respectively, completed the study. Mean improvements from baseline to week 24 in UPDRS III total scores were -3.90 for safinamide 200 mg, -6.0 for safinamide 100 mg and -3.60 for placebo. The difference between safinamide 200 mg and placebo was not significant [point estimate: -0.4; 95% confidence interval (CI): -2.3-1.4; P = 0.6504]. Although the difference between 100 mg/day and placebo was significant (point estimate: -1.9; 95% CI: -3.7 to -0.1; P = 0.0419), these results are considered exploratory. No clinically meaningful differences from placebo were observed for any safety variables. This study did not demonstrate a significant improvement of the primary endpoint for safinamide 200 mg/day. Exploratory analysis of the primary endpoint for 100 mg/day demonstrated that the addition of safinamide to a stable dose of DA improves motor symptoms in early PD and warrants further investigation.
CC :	002B17; 002B17G
FD :	Maladie de Parkinson; Pathologie du système nerveux; Placebo; Safinamide; Traitement; Homme; Dopamine
FG :	Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du système nerveux central; Catécholamine; Neurotransmetteur
ED :	Parkinson disease; Nervous system diseases; Placebo; Safinamide; Treatment; Human; Dopamine
EG :	Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease; Catecholamine; Neurotransmitter
SD :	Parkinson enfermedad; Sistema nervioso patología; Placebo; Safinamida; Tratamiento; Hombre; Dopamina
LO :	INIST-20953.354000508687520160
ID :	12-0106491

Links to Exploration step

Pascal:12-0106491

Le document en format XML

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<front><div type="abstract" xml:lang="en">Safinamide is an α-aminoamide with both dopaminergic and nondopaminergic mechanisms of action evaluated as an add-on to dopamine agonist (DA) therapy in early-stage PD. In this 24-week, double-blind study, patients with early PD receiving a stable dose of a single DA were randomized to once-daily safinamide 100 mg, safinamide 200 mg, or placebo. The primary efficacy variable was UPDRS part III (motor examination) total score. Analysis was hierarchical: 200 mg of safinamide versus placebo was tested first; the success of safinamide 100 mg versus placebo was contingent on this. Two hundred sixty-nine patients received safinamide 100 mg (n = 90), safinamide 200 mg (n = 89), or placebo (n = 90); 70, 81, and 81 patients, respectively, completed the study. Mean improvements from baseline to week 24 in UPDRS III total scores were -3.90 for safinamide 200 mg, -6.0 for safinamide 100 mg and -3.60 for placebo. The difference between safinamide 200 mg and placebo was not significant [point estimate: -0.4; 95% confidence interval (CI): -2.3-1.4; P = 0.6504]. Although the difference between 100 mg/day and placebo was significant (point estimate: -1.9; 95% CI: -3.7 to -0.1; P = 0.0419), these results are considered exploratory. No clinically meaningful differences from placebo were observed for any safety variables. This study did not demonstrate a significant improvement of the primary endpoint for safinamide 200 mg/day. Exploratory analysis of the primary endpoint for 100 mg/day demonstrated that the addition of safinamide to a stable dose of DA improves motor symptoms in early PD and warrants further investigation.</div>
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<s3>IND</s3>
<sZ>2 aut.</sZ>
</fA14>
<fA14 i1="03"><s1>Department of Neurology, Chieti-Pescara University</s1>
<s2>Chieti</s2>
<s3>ITA</s3>
<sZ>3 aut.</sZ>
</fA14>
<fA14 i1="04"><s1>Department of Clinical Neurosciences, UCL Institute of Neurology</s1>
<s2>London</s2>
<s3>GBR</s3>
<sZ>4 aut.</sZ>
</fA14>
<fA14 i1="05"><s1>Movement Disorder Clinic</s1>
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</fA14>
<fA14 i1="06"><s1>Development Department, Newron Pharmaceuticals</s1>
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<s3>ITA</s3>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
</fA14>
<fA14 i1="07"><s1>APC</s1>
<s2>St. Moritz</s2>
<s3>CHE</s3>
<sZ>8 aut.</sZ>
</fA14>
<fA20><s1>106-112</s1>
</fA20>
<fA21><s1>2012</s1>
</fA21>
<fA23 i1="01"><s0>ENG</s0>
</fA23>
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<s1>© 2012 INIST-CNRS. All rights reserved.</s1>
</fA44>
<fA45><s0>20 ref.</s0>
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<fA60><s1>P</s1>
</fA60>
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</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>
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<s5>01</s5>
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<s5>01</s5>
</fC03>
<fC03 i1="02" i2="X" l="FRE"><s0>Pathologie du   système nerveux</s0>
<s5>02</s5>
</fC03>
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<s5>02</s5>
</fC03>
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<s5>02</s5>
</fC03>
<fC03 i1="03" i2="X" l="FRE"><s0>Placebo</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="ENG"><s0>Placebo</s0>
<s5>09</s5>
</fC03>
<fC03 i1="03" i2="X" l="SPA"><s0>Placebo</s0>
<s5>09</s5>
</fC03>
<fC03 i1="04" i2="X" l="FRE"><s0>Safinamide</s0>
<s2>FR</s2>
<s5>10</s5>
</fC03>
<fC03 i1="04" i2="X" l="ENG"><s0>Safinamide</s0>
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<s5>10</s5>
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<fC03 i1="04" i2="X" l="SPA"><s0>Safinamida</s0>
<s2>FR</s2>
<s5>10</s5>
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<s5>11</s5>
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<s5>12</s5>
</fC03>
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<s5>12</s5>
</fC03>
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<s5>12</s5>
</fC03>
<fC03 i1="07" i2="X" l="FRE"><s0>Dopamine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="ENG"><s0>Dopamine</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>13</s5>
</fC03>
<fC03 i1="07" i2="X" l="SPA"><s0>Dopamina</s0>
<s2>NK</s2>
<s2>FR</s2>
<s5>13</s5>
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<fC07 i1="01" i2="X" l="FRE"><s0>Pathologie de l'encéphale</s0>
<s5>37</s5>
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<s5>37</s5>
</fC07>
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<s5>37</s5>
</fC07>
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<s5>38</s5>
</fC07>
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<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>
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<s5>42</s5>
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<s5>42</s5>
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<s5>42</s5>
</fC07>
<fC07 i1="06" i2="X" l="FRE"><s0>Neurotransmetteur</s0>
<s5>43</s5>
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<s5>43</s5>
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<fC07 i1="06" i2="X" l="SPA"><s0>Neurotransmisor</s0>
<s5>43</s5>
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<fN21><s1>079</s1>
</fN21>
<fN44 i1="01"><s1>OTO</s1>
</fN44>
<fN82><s1>OTO</s1>
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<server><NO>PASCAL 12-0106491 INIST</NO>
<ET>A Randomized, Double-Blind, Placebo-Controlled Trial of Safinamide as Add-on Therapy in Early Parkinson's Disease Patients</ET>
<AU>STOCCHI (Fabrizio); BORGOHAIN (Rupam); ONOFRJ (Marco); SCHAPIRA (Anthony H. V.); BHATT (Mohit); LUCINI (Valentina); GIULIANI (Rodolfo); ANAND (Ravi)</AU>
<AF>Department of Neuroscience, IRCCS San Raffaele/Rome/Italie (1 aut.); Department of Neurology, Nizam's Institute of Medical Sciences/Hyderabad/Inde (2 aut.); Department of Neurology, Chieti-Pescara University/Chieti/Italie (3 aut.); Department of Clinical Neurosciences, UCL Institute of Neurology/London/Royaume-Uni (4 aut.); Movement Disorder Clinic/Mumbai/Inde (5 aut.); Development Department, Newron Pharmaceuticals/Milan/Italie (6 aut., 7 aut.); APC/St. Moritz/Suisse (8 aut.)</AF>
<DT>Publication en série; Niveau analytique</DT>
<SO>Movement disorders; ISSN 0885-3185; Etats-Unis; Da. 2012; Vol. 27; No. 1; Pp. 106-112; Bibl. 20 ref.</SO>
<LA>Anglais</LA>
<EA>Safinamide is an α-aminoamide with both dopaminergic and nondopaminergic mechanisms of action evaluated as an add-on to dopamine agonist (DA) therapy in early-stage PD. In this 24-week, double-blind study, patients with early PD receiving a stable dose of a single DA were randomized to once-daily safinamide 100 mg, safinamide 200 mg, or placebo. The primary efficacy variable was UPDRS part III (motor examination) total score. Analysis was hierarchical: 200 mg of safinamide versus placebo was tested first; the success of safinamide 100 mg versus placebo was contingent on this. Two hundred sixty-nine patients received safinamide 100 mg (n = 90), safinamide 200 mg (n = 89), or placebo (n = 90); 70, 81, and 81 patients, respectively, completed the study. Mean improvements from baseline to week 24 in UPDRS III total scores were -3.90 for safinamide 200 mg, -6.0 for safinamide 100 mg and -3.60 for placebo. The difference between safinamide 200 mg and placebo was not significant [point estimate: -0.4; 95% confidence interval (CI): -2.3-1.4; P = 0.6504]. Although the difference between 100 mg/day and placebo was significant (point estimate: -1.9; 95% CI: -3.7 to -0.1; P = 0.0419), these results are considered exploratory. No clinically meaningful differences from placebo were observed for any safety variables. This study did not demonstrate a significant improvement of the primary endpoint for safinamide 200 mg/day. Exploratory analysis of the primary endpoint for 100 mg/day demonstrated that the addition of safinamide to a stable dose of DA improves motor symptoms in early PD and warrants further investigation.</EA>
<CC>002B17; 002B17G</CC>
<FD>Maladie de Parkinson; Pathologie du   système nerveux; Placebo; Safinamide; Traitement; Homme; Dopamine</FD>
<FG>Pathologie de l'encéphale; Syndrome extrapyramidal; Maladie dégénérative; Pathologie du   système nerveux central; Catécholamine; Neurotransmetteur</FG>
<ED>Parkinson disease; Nervous system diseases; Placebo; Safinamide; Treatment; Human; Dopamine</ED>
<EG>Cerebral disorder; Extrapyramidal syndrome; Degenerative disease; Central nervous system disease; Catecholamine; Neurotransmitter</EG>
<SD>Parkinson enfermedad; Sistema nervioso patología; Placebo; Safinamida; Tratamiento; Hombre; Dopamina</SD>
<LO>INIST-20953.354000508687520160</LO>
<ID>12-0106491</ID>
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	Movement Disorders (revue)
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Movement Disorders (revue)

A Randomized, Double-Blind, Placebo-Controlled Trial of Safinamide as Add-on Therapy in Early Parkinson's Disease Patients

A Randomized, Double-Blind, Placebo-Controlled Trial of Safinamide as Add-on Therapy in Early Parkinson's Disease Patients

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