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
- Conditions
- Parkinson Disease
- Registration Number
- NCT00148512
- Lead Sponsor
- Boehringer Ingelheim
- Brief Summary
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.
- Detailed Description
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
Study Hypothesis:
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.
Comparison(s):
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 254
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Primary Outcome Measures
Name Time Method UPDRS parts II (averaged "on" and "off") 14 weeks "Off" time during waking hours 14 weeks
- Secondary Outcome Measures
Name Time Method Modified Schwab and England Disability scale 14 weeks Snaith-Hamilton Pleasure Scale (SHAPS) 14 weeks Percentage of patients with at least a 20%-improvement in percent "off" time during waking hours 14 weeks Percentage of patients with at least a 20% or a 30%-improvement in UPDRS parts II+III total score 14 weeks Percent on time without dyskinesia, or with non troublesome dyskinesia, or both, or with troublesome dyskinesia 14 weeks Unified Parkinson's Disease Rating Scale (UPDRS) I to IV sub-scores 14 weeks Clinical Global Impressions (CGI) Improvement and Severity 14 weeks Auditory Verbal Learning test (AVLT) 14 weeks
Trial Locations
- Locations (40)
Krankenhaus d. Barmherzigen Brüder Graz-Eggenberg
🇦🇹Graz, Austria
Univ.-Klinik für Neurologie
🇦🇹Innsbruck, Austria
Landesnervenklinik Wagner Jauregg Linz
🇦🇹Linz, Austria
AKH der Stadt Linz
🇦🇹Linz, Austria
Landesklinikum St. Pölten
🇦🇹St. Pölten, Austria
Hôpital du Pays d'Aix
🇫🇷Aix en Provence, France
Hôpital Pierre Wertheimer
🇫🇷Bron cedex, France
Hôpital Gabriel Montpied
🇫🇷Clermont Ferrand, France
Hôpital Roger Salengro
🇫🇷Lille cedex, France
Hôpital de la Timone
🇫🇷Marseille, France
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