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

Phase 3CompletedNCT00190268

Assistance Publique - Hôpitaux de Paris126 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

126

Conditions

Multiple Sclerosis

Interventions

3,4-diaminopyridineDRUG

3,4-diaminopyridine

Eligibility

Sex: ALLMin age: 18 YearsMax age: 60 Years

Medical Language ↔ Plain English

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

Locations (4)

Henri Mondor Hospital

Créteil, France

Pitié Salpetriere Hospital

Paris, France

Tenon Hospital

Paris, France

Pontchaillou Hospital

Rennes, France

Outcomes

Primary Outcomes

improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.

Time frame: 43 months

Secondary Outcomes

evaluation of safety

Time frame: 43 months

quality of life impact

Time frame: 43 months

Data from ClinicalTrials.gov

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