Double-blind, randomized, controlled trial of Rasagiline as monotherapy in early Parkinson's Disease patients
Identifieur interne : 002170 ( PascalFrancis/Checkpoint ); précédent : 002169; suivant : 002171Double-blind, randomized, controlled trial of Rasagiline as monotherapy in early Parkinson's Disease patients
Auteurs : Matthew B. Stern [États-Unis] ; Kenneth L. Marek [États-Unis] ; Joseph Friedman [États-Unis] ; Robert A. Hauser [États-Unis] ; Peter A. Lewitt [États-Unis] ; Daniel Tarsy [États-Unis] ; C. Warren Olanow [États-Unis]Source :
- Movement disorders [ 0885-3185 ] ; 2004.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
Abstract
Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (±1.3), -3.6 (±1.7), -3.6 (±1.2), and -0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD.
Affiliations:
- États-Unis
- Connecticut, Floride, Massachusetts, Michigan, Pennsylvanie, Rhode Island, État de New York
- Tampa
- Université de Floride du Sud
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<front><div type="abstract" xml:lang="en">Rasagiline (N-propargyl-1(R)-aminoindan) mesylate is a potent, selective, and irreversible monoamine oxidase-B inhibitor. This study was designed to evaluate the safety, tolerability, and preliminary efficacy of rasagiline monotherapy in early Parkinson's disease (PD) patients not receiving levodopa. The study was performed as a multicenter, parallel-group, double-blind, randomized, placebo-controlled, 10-week study. Fifty-six PD patients were randomly assigned to rasagiline mesylate 1, 2, or 4 mg once daily, or placebo. A 3-week dose-escalation period was followed by a 7-week maintenance phase. At week 10, the mean (±SE) changes from baseline in total Unified Parkinson's Disease Rating Scale (UPDRS) score were -1.8 (±1.3), -3.6 (±1.7), -3.6 (±1.2), and -0.5 (±0.8) in the rasagiline 1, 2, and 4 mg/day and placebo groups, respectively. Analysis of responders showed that 28% of patients (12 of 43) receiving rasagiline had an improvement in total UPDRS score of greater than 30%, compared with none of the patients receiving placebo (P < 0.05, Fisher's exact test). The frequency and types of adverse events reported by rasagiline-treated and placebo-treated patients were similar. These results suggest that rasagiline monotherapy is well tolerated and efficacious in early PD.</div>
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<name sortKey="Tarsy, Daniel" sort="Tarsy, Daniel" uniqKey="Tarsy D" first="Daniel" last="Tarsy">Daniel Tarsy</name>
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