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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
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|