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

Assistance Publique - Hôpitaux de Paris

Status and phase: Completed; Phase 3

Conditions: Multiple Sclerosis

Treatments: Drug: 3,4-diaminopyridine

Study type: Interventional

Funder types: Other

Identifiers

NCT00190268

P020304

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 126 patients

Sex: All

Ages: 18 to 60 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

126 participants in 1 patient group

3,4-diaminopyridine

Experimental group

Description:

3,4-diaminopyridine

Treatment:

Drug: 3,4-diaminopyridine