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

Phase 3

Completed

• Conditions: Multiple Sclerosis
• Interventions: Drug: 3,4-diaminopyridine

• Registration Number: NCT00190268
• Lead Sponsor: Assistance Publique - Hôpitaux de Paris

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2005-02
• Study First Submitted: 2005-09-13
• Study First Submitted QC: 2005-09-13
• Study First Posted: 2005-09-19
• Status Verified: 2007-03
• Primary Completion: 2008-06
• Study Completion: 2008-06
• Last Update Submitted: 2011-02-18
• Last Update Posted: 2011-02-21

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 126

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
3,4-diaminopyridine	3,4-diaminopyridine	3,4-diaminopyridine

Primary Outcome Measures

Name	Time	Method
improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.	43 months	improvement of fatigue measured by a decrease of EMIF-SEP score compared to placebo group.

Secondary Outcome Measures

Name	Time	Method
evaluation of safety	43 months	evaluation of safety
quality of life impact	43 months	quality of life impact

Trial Locations

Locations (4)

Tenon Hospital; 🇫🇷 Paris, France

Pontchaillou Hospital; 🇫🇷 Rennes, France

Pitié Salpetriere Hospital; 🇫🇷 Paris, France

Henri Mondor Hospital; 🇫🇷 Creteil, France