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
|First Received Date ICMJE||September 7, 2005|
|Last Updated Date||January 12, 2007|
|Start Date ICMJE||March 2003|
|Primary Completion Date||Not Provided|
|Current Primary Outcome Measures ICMJE
||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|
|Original Primary Outcome Measures ICMJE||Same as current|
|Change History||Complete list of historical versions of study NCT00148512 on ClinicalTrials.gov Archive Site|
|Current Secondary Outcome Measures ICMJE
|Original Secondary Outcome Measures ICMJE||Same as current|
|Current Other Outcome Measures ICMJE||Not Provided|
|Original Other Outcome Measures ICMJE||Not Provided|
|Brief Title ICMJE||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|
|Official Title ICMJE||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|
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.
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.
|Study Type ICMJE||Interventional|
|Study Phase||Phase 2|
|Study Design ICMJE||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Primary Purpose: Treatment
|Condition ICMJE||Parkinson Disease|
|Intervention ICMJE||Drug: 1. Tesofensine (NS 2330)|
|Study Arm (s)||Not Provided|
|Publications *||Rascol O, Poewe W, Lees A, Aristin M, Salin L, Juhel N, Waldhauser L, Schindler T; ADVANS Study Group. Tesofensine (NS 2330), a monoamine reuptake inhibitor, in patients with advanced Parkinson disease and motor fluctuations: the ADVANS Study. Arch Neurol. 2008 May;65(5):577-83.|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
|Recruitment Status ICMJE||Completed|
|Completion Date||February 2005|
|Primary Completion Date||Not Provided|
|Eligibility Criteria ICMJE||
Main inclusion criteria:
Main exclusion criteria:
|Ages||42 Years to 80 Years|
|Accepts Healthy Volunteers||No|
|Contacts ICMJE||Contact information is only displayed when the study is recruiting subjects|
|Location Countries ICMJE||Austria, France, Germany, Netherlands, Spain, United Kingdom|
|NCT Number ICMJE||NCT00148512|
|Other Study ID Numbers ICMJE||1198.101|
|Has Data Monitoring Committee||Not Provided|
|Responsible Party||Not Provided|
|Study Sponsor ICMJE||Boehringer Ingelheim Pharmaceuticals|
|Collaborators ICMJE||Not Provided|
|Information Provided By||Boehringer Ingelheim Pharmaceuticals|
|Verification Date||January 2007|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP