Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis

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

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.

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.

Inclusion Criteria:

• Age >= 18 years and = <60 years
• Patients with multiple sclerosis clinically defined and with MIFS-SEP score > 44, without deficit sleep and without depression.
• Patients without treatment by 3,4-DAP since 3 months
• EDSS score < 6

Exclusion Criteria:

• ASAT/ALAT > 2 x ULN
• MADRS >= 20
• Abnormality cardiac rhythm
• Pregnancy
• Asthma
• Evolutive affection
• Renal failure