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
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Official Title:||A Randomized, Double-blind, Placebo-controlled, Five Parallel Groups Efficacy and Safety Exploratory Study of NS 2330 (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 (Study for Proof of Concept in ADVAnced Parkinson Disease of NS 2330 / ADVANS)|
- UPDRS parts II (averaged "on" and "off") [ Time Frame: 14 weeks ]
- "Off" time during waking hours [ Time Frame: 14 weeks ]
- Percent on time without dyskinesia, or with non troublesome dyskinesia, or both, or with troublesome dyskinesia [ Time Frame: 14 weeks ]
- Unified Parkinson's Disease Rating Scale (UPDRS) I to IV sub-scores [ Time Frame: 14 weeks ]
- Clinical Global Impressions (CGI) Improvement and Severity [ Time Frame: 14 weeks ]
- Auditory Verbal Learning test (AVLT) [ Time Frame: 14 weeks ]
- Modified Schwab and England Disability scale [ Time Frame: 14 weeks ]
- Snaith-Hamilton Pleasure Scale (SHAPS) [ Time Frame: 14 weeks ]
- Percentage of patients with at least a 20%-improvement in percent "off" time during waking hours [ Time Frame: 14 weeks ]
- Percentage of patients with at least a 20% or a 30%-improvement in UPDRS parts II+III total score [ Time Frame: 14 weeks ]
|Study Start Date:||March 2003|
|Estimated Study Completion Date:||February 2005|
|Primary Completion Date:||February 2005 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00148512
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|Study Chair:||Boehringer Ingelheim Study Coordinator||BI France S.A.S.|