A Randomized, Double-Blind, Placebo-Controlled, Five Parallel Groups Efficacy and Safety Study of NS 2330 (Tesofensine) (0.125 mg, 0.25 mg, 0.5 mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations
The primary objective of this exploratory study is to investigate the efficacy and safety of tesofensine in daily doses (from 0.125 mg to 1.0 mg) in comparison to placebo, over a 14-week treatment period in levodopa treated Parkinson patients with motor fluctuations.
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized Double-Blind Placebo-Controlled Five Parallel-Group Efficacy and Safety Exploratory Study of NS 2330 (0.125mg, 0.25mg, 0.5mg and 1.0 mg) Administered Orally Once Daily Over 14 Weeks in Levodopa Treated Parkinson Patients With Motor Fluctuations (Study for Proof of Concept in ADVAnced Pa|
- There are two co-primary efficacy outcomes in this study: change in percent off-time during waking hours (based on reports from patient's diary) and change in UPDRS II+III total score
- Percent on time without dyskinesia, or with non troublesome dysk., or both, or with troublesome dysk.
- Each of UPDRS I to IV sub-scores separately
- CGI-Improvement and Severity
- Modified Schwab and England Disability scale
- % responders
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||February 2005|
This is a randomized, double-blind, placebo-controlled, five parallel groups efficacy and safety exploratory of tesofensine versus placebo in levodopa treated Parkinson patients with motor fluctuations.
Patients will be treated either with one of the 4 doses of tesofensine (0.125mg, 0.25mg, 0.50 mg or 1.0 mg) or with placebo, once daily, over 14 weeks.
The two co-primary efficacy endpoints are the change in off-time and the change in the Unified Parkinson Disease Rating Scale (UPDRS) II+III total score
The null hypothesis is that there is no difference between placebo and tesofensine.
The alternative hypothesis is that treatment with tesofensine is superior to treatment with placebo.
For the primary comparison between tesofensine and placebo, change in percentage off-time during waking hours will be based on reports from patient's diary (completed at day -3 and day-2 prior to the study visits) and change in the UPDRS II+III will be based on UPDRS II averaged for on and off periods and UPDRS III evaluated at on periods during the study visits.
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|Study Chair:||Boehringer Ingelheim Study Coordinator||BI France S.A.S.|