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Tracking Information | |||||
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First Received Date † | September 7, 2005 | ||||
Last Updated Date | January 12, 2007 | ||||
Start Date † | March 2003 | ||||
Current Primary Outcome Measures † |
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 † | Same as current | ||||
Change History | Complete list of historical versions of study NCT00148512 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † |
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Original Secondary Outcome Measures † | Same as current | ||||
Descriptive Information | |||||
Brief Title † | 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 † | 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 | ||||
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. |
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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. |
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Study Phase | Phase II | ||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Double-Blind, Placebo Control, Parallel Assignment, Safety/Efficacy Study | ||||
Condition † | Parkinson Disease | ||||
Intervention † | Drug: 1. Tesofensine (NS 2330) | ||||
Study Arms / Comparison Groups | |||||
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 National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | 250 | ||||
Completion Date | February 2005 | ||||
Primary Completion Date | |||||
Eligibility Criteria † | Main inclusion criteria:
Main exclusion criteria:
severe renal impairment), etc
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Gender | Both | ||||
Ages | 42 Years to 80 Years | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | Austria, France, Germany, Netherlands, Spain, United Kingdom | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00148512 | ||||
Responsible Party | |||||
Secondary IDs †† | |||||
Study Sponsor † | Boehringer Ingelheim Pharmaceuticals | ||||
Collaborators †† | |||||
Investigators † |
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Information Provided By | Boehringer Ingelheim Pharmaceuticals | ||||
Verification Date | January 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |