A Randomized, Double-Blind, Placebo-Controlled Trial of Safinamide as Add-on Therapy in Early Parkinson's Disease Patients
Identifieur interne : 001227 ( Main/Exploration ); précédent : 001226; suivant : 001228A Randomized, Double-Blind, Placebo-Controlled Trial of Safinamide as Add-on Therapy in Early Parkinson's Disease Patients
Auteurs : Fabrizio Stocchi [Italie] ; Rupam Borgohain [Inde] ; Marco Onofrj [Italie] ; Anthony H. V. Schapira [Royaume-Uni] ; Mohit Bhatt [Inde] ; Valentina Lucini [Italie] ; Rodolfo Giuliani [Italie] ; Ravi Anand [Suisse]Source :
- Movement disorders [ 0885-3185 ] ; 2012.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
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.
Affiliations:
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V." last="Schapira">Anthony H. V. Schapira</name><affiliation wicri:level="3"><inist:fA14 i1="04"><s1>Department of Clinical Neurosciences, UCL Institute of Neurology</s1><s2>London</s2><s3>GBR</s3><sZ>4 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Bhatt, Mohit" sort="Bhatt, Mohit" uniqKey="Bhatt M" first="Mohit" last="Bhatt">Mohit Bhatt</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Movement Disorder Clinic</s1><s2>Mumbai</s2><s3>IND</s3><sZ>5 aut.</sZ></inist:fA14><country>Inde</country><wicri:noRegion>Movement Disorder Clinic</wicri:noRegion></affiliation></author><author><name sortKey="Lucini, Valentina" sort="Lucini, Valentina" uniqKey="Lucini V" first="Valentina" last="Lucini">Valentina Lucini</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Development Department, Newron Pharmaceuticals</s1><s2>Milan</s2><s3>ITA</s3><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Giuliani, Rodolfo" sort="Giuliani, Rodolfo" uniqKey="Giuliani R" first="Rodolfo" last="Giuliani">Rodolfo Giuliani</name><affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Development Department, Newron Pharmaceuticals</s1><s2>Milan</s2><s3>ITA</s3><sZ>6 aut.</sZ><sZ>7 aut.</sZ></inist:fA14><country>Italie</country><placeName><settlement type="city">Milan</settlement><region nuts="2">Lombardie</region></placeName></affiliation></author><author><name sortKey="Anand, Ravi" sort="Anand, Ravi" uniqKey="Anand R" first="Ravi" last="Anand">Ravi Anand</name><affiliation wicri:level="1"><inist:fA14 i1="07"><s1>APC</s1><s2>St. Moritz</s2><s3>CHE</s3><sZ>8 aut.</sZ></inist:fA14><country>Suisse</country><wicri:noRegion>APC</wicri:noRegion></affiliation></author></analytic><series><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Movement disorders</title><title level="j" type="abbreviated">Mov. disord.</title><idno type="ISSN">0885-3185</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Dopamine</term><term>Human</term><term>Nervous system diseases</term><term>Parkinson disease</term><term>Placebo</term><term>Safinamide</term><term>Treatment</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Maladie de Parkinson</term><term>Pathologie du système nerveux</term><term>Placebo</term><term>Safinamide</term><term>Traitement</term><term>Homme</term><term>Dopamine</term></keywords><keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term></keywords></textClass></profileDesc></teiHeader><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></front></TEI><affiliations><list><country><li>Inde</li><li>Italie</li><li>Royaume-Uni</li><li>Suisse</li></country><region><li>Angleterre</li><li>Grand Londres</li><li>Latium</li><li>Lombardie</li></region><settlement><li>Londres</li><li>Milan</li><li>Rome</li></settlement></list><tree><country name="Italie"><region name="Latium"><name sortKey="Stocchi, Fabrizio" sort="Stocchi, Fabrizio" uniqKey="Stocchi F" first="Fabrizio" last="Stocchi">Fabrizio Stocchi</name></region><name sortKey="Giuliani, Rodolfo" sort="Giuliani, Rodolfo" uniqKey="Giuliani R" first="Rodolfo" last="Giuliani">Rodolfo Giuliani</name><name sortKey="Lucini, Valentina" sort="Lucini, Valentina" uniqKey="Lucini V" first="Valentina" last="Lucini">Valentina Lucini</name><name sortKey="Onofrj, Marco" sort="Onofrj, Marco" uniqKey="Onofrj M" first="Marco" last="Onofrj">Marco Onofrj</name></country><country name="Inde"><noRegion><name sortKey="Borgohain, Rupam" sort="Borgohain, Rupam" uniqKey="Borgohain R" first="Rupam" last="Borgohain">Rupam Borgohain</name></noRegion><name sortKey="Bhatt, Mohit" sort="Bhatt, Mohit" uniqKey="Bhatt M" first="Mohit" last="Bhatt">Mohit Bhatt</name></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Schapira, Anthony H V" sort="Schapira, Anthony H V" uniqKey="Schapira A" first="Anthony H. V." last="Schapira">Anthony H. V. Schapira</name></region></country><country name="Suisse"><noRegion><name sortKey="Anand, Ravi" sort="Anand, Ravi" uniqKey="Anand R" first="Ravi" last="Anand">Ravi Anand</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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