Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis
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.
|Study Design:||Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
|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|
- improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group. [ Time Frame: 43 months ] [ Designated as safety issue: Yes ]improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.
- evaluation of safety [ Time Frame: 43 months ] [ Designated as safety issue: Yes ]evaluation of safety
- quality of life impact [ Time Frame: 43 months ] [ Designated as safety issue: Yes ]quality of life impact
|Study Start Date:||February 2005|
|Study Completion Date:||June 2008|
|Primary Completion Date:||June 2008 (Final data collection date for primary outcome measure)|
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.
Please refer to this study by its ClinicalTrials.gov identifier: 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|