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[求助]
Xadago - EPAR - Public assessment report + 临床药学 + 2015/04/09
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求专业人士帮忙翻译Safinamide的药学临床研究资料，先在此谢过了！！！ 2.8.2.3. Impulsive-compulsive disorders Safinamide also was not associated with an increase in impulsive/compulsive behavior, as assessed by the QUIP (Parkinson's Disease Impulsive-Compulsive Disorders Questionnaire, a self-administered questionnaire specifically designed to assess the severity of symptoms of impulse control disorders (e.g.pathological gambling, buying, eating, and sexual behaviour) in patients with Parkinson’s disease. The QUIP was performed in two studies: Study 27918 (MOTION) and 27919 (SETTLE). Data analysed from overall Group 1 safety population of MOTION and SETTLE showed that changes from baseline in the QUIP scale were similar in the safinamide and placebo groups. Among all subjects who received safinamide, 272 subjects (74.5%) showed no compulsive behaviour at baseline, as evaluated by the QUIP Scale; 49 subjects (13.4%) displayed one act of a compulsive behaviour and 44 subjects (12.1%) displayed 2 or more acts of compulsive behaviour at baseline. Post-baseline evaluations indicated no significant changes, showing that 55 subjects (15.1%) had one act of a compulsive behaviour and 46 (12.6%) displayed 2 or more acts of compulsive behaviour as worst post-baseline values. The incidence is similar to placebo patients. Similar shifts from baseline to worst post-baseline evaluations were observed in safinamide treatment groups, to those seen in the placebo group. |
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