Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis
- 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 126
- 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
- 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
Related Research Topics
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Trial Locations
- Locations (4)
Henri Mondor Hospital
🇫🇷Creteil, France
Pitié Salpetriere Hospital
🇫🇷Paris, France
Tenon Hospital
🇫🇷Paris, France
Pontchaillou Hospital
🇫🇷Rennes, France
Henri Mondor Hospital🇫🇷Creteil, France