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

• Status: Completed
• Trial end date: 2008-06-01
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Treatments: 3,4-diaminopyridine; 4-Aminopyridine; Amifampridine

Criteria

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