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)
To demonstrate efficacy and dose-response of NS 2330 versus placebo in patients with early Parkinson's Disease in 14 weeks of treatment, and to investigate the safety and tolerability of NS 2330 in these patients.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||14-Week Placebo-Controlled Dose-Response Efficacy and Safety in Early PD (SCEPTRE)|
- The primary endpoint was the mean change in score of the UPDRS, Parts I-III combined, from Baseline to Week 14.
- Secondary efficacy measures were mean change in: Part I, Part II, and Part III (separately) of the UPDRS, the CGI-Severity, the Modified Hoehn and Yahr Scale, the Modified Schwab-England Disability Scale (MSED) and the HAMD.
|Study Start Date:||June 2003|
|Estimated Study Completion Date:||September 2005|
Show 55 Study Locations
|Study Chair:||Boehringer Ingelheim Study Coordinator||Boehringer Ingelheim Pharmaceuticals|