Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis
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|ClinicalTrials.gov Identifier: NCT00190268|
Recruitment Status : Completed
First Posted : September 19, 2005
Last Update Posted : February 21, 2011
Rational of study : 3,4-diaminopyridine is suspected to improved the fatigue associated in patient's multiple sclerosis.
In order to confirm this hypothesis, a randomized, controlled versus placebo, double blinded study is performed.
|Condition or disease||Intervention/treatment||Phase|
|Multiple Sclerosis||Drug: 3,4-diaminopyridine||Phase 3|
We proposed a randomized controlled trial between 3,4-diaminopyridine and placebo .
The main objective : improvement of fatigue by diminution of EMIF-SEP score between the arm treatment and placebo arm. The hypothesis tested is that the 3,4-DAP is efficacy in the fatigue of multiple sclerosis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||126 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Multicentric Study, Comparative, Randomized, in Double Knowledge of the Effectiveness (Versus Placebo) of a Salt Of 3,4 - Diaminopyridine in the Treatment of Tiredness During the Multiple Sclerosis|
|Study Start Date :||February 2005|
|Actual Primary Completion Date :||June 2008|
|Actual Study Completion Date :||June 2008|
- improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group. [ Time Frame: 43 months ]improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.
- evaluation of safety [ Time Frame: 43 months ]evaluation of safety
- quality of life impact [ Time Frame: 43 months ]quality of life impact
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00190268
|Henri Mondor Hospital|
|Creteil, France, 94010|
|Pitié Salpetriere Hospital|
|Paris, France, 75013|
|Paris, France, 75020|
|Rennes, France, 35000|
|Study Chair:||Pierre Cesaro, MD||Hopital Henri Mondor-France|