Status:
COMPLETED
Efficacy of 3,4-DAP in Fatigue Associated With Multiple Sclerosis
Lead Sponsor:
Assistance Publique - Hôpitaux de Paris
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-60 years
Phase:
PHASE3
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, ...
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 a...
Eligibility Criteria
Inclusion
- 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
- ASAT/ALAT \> 2 x ULN
- MADRS \>= 20
- Abnormality cardiac rhythm
- Pregnancy
- Asthma
- Evolutive affection
- Renal failure
Key Trial Info
Start Date :
February 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2008
Estimated Enrollment :
126 Patients enrolled
Trial Details
Trial ID
NCT00190268
Start Date
February 1 2005
End Date
June 1 2008
Last Update
February 21 2011
Active Locations (4)
Enter a location and click search to find clinical trials sorted by distance.
1
Henri Mondor Hospital
Créteil, France, 94010
2
Pitié Salpetriere Hospital
Paris, France, 75013
3
Tenon Hospital
Paris, France, 75020
4
Pontchaillou Hospital
Rennes, France, 35000