A Fourteen-week Placebo-controlled Dose-response Efficacy and Safety Study of NS 2330 in Early Parkinson's Disease Patients (Study for Proof of Concept in Early Parkinson's Disease of a Triple Reuptake Inhibitor, NS 2330 / SCEPTRE)

简要总结

主要结局

次要结局

• Mean change in Part I, Part II, and Part III (separately) of the UPDRS(14 weeks)
• Mean change in the Clinical Global Impressions (CGI)-Severity scale(14 weeks)
• Mean change in the Modified Hoehn and Yahr Scale (MHYS)(14 weeks)
• Mean change in the Hamilton Depression Scale (HAMD) (GRID version) (including an additional analysis of the subset of patients with a pretreatment [screening] score of 14 or more)(14 weeks)
• Mean change in the Auditory Verbal Learning Test (AVLT)(14 weeks)
• mean score at Week 14 on the CGI-Improvement (which has no baseline rating)(14 weeks)
• patients with abnormal laboratory test measurements(20 weeks)
• patients with abnormalities in electrocardiograms (ECGs)(20 weeks)
• Epworth Sleepiness Scale (ESS) (for daytime sleepiness)(20 weeks)
• Proportion of responder patients (20% and 30% improved on the total score of the UPDRS)(14 weeks)
• vital signs (blood pressure and pulse rate)(20 weeks)
• Mean change in the Modified Schwab-England Disability Scale (MSED)(14 weeks)
• Mean change in Snaith-Hamilton Pleasure Scale (SHAPS) (including an additional analysis of the subset of patients with a pretreatment [screening] score of 3 or more)(14 weeks)
• Incidence of adverse events(2 weeks)
• Pittsburgh Sleep Quality Index (PSQI) for quality and pattern of sleep(20 weeks)
• Drug plasma concentration(20 weeks)