ClinicalTrials.Veeva

Menu

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

A

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

Trial contacts and locations

4

Loading...

Data sourced from clinicaltrials.gov

Clinical trials

Find clinical trialsTrials by location
© Copyright 2025 Veeva Systems