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

Multicentric Study, Comparative, Randomized, in Double Knowledge of the Effectiveness (Versus Placebo) of a Salt Of 3,4 - Diaminopyridine in the Treatment of Tiredness During the Multiple Sclerosis

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00190268

Enrollment

126

Registered

2005-09-19

Start date

2005-02-28

Completion date

2008-06-30

Last updated

2011-02-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Multiple Sclerosis

Keywords

multiple sclerosis, fatigue, 3,4-diaminopyridine

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.

Interventions

DRUG3,4-diaminopyridine

3,4-diaminopyridine

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender

ALL

Age

18 Years to 60 Years

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
evaluation of safety	43 months	evaluation of safety
quality of life impact	43 months	quality of life impact

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026