Status:
UNKNOWN
Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses
Lead Sponsor:
Rennes University Hospital
Conditions:
Multiple Sclerosis, Relapsing-Remitting
Eligibility:
All Genders
18-55 years
Phase:
PHASE3
Brief Summary
The efficacy of oral corticosteroids for the treatment of relapses of multiple sclerosis has not been proved. French neurologists treat such patients with intravenous corticosteroids. The aim of the s...
Eligibility Criteria
Inclusion
- age 18 to 55
- informed written consent
- multiple sclerosis (Mc Donald criteria, relapsing-remitting
- EDSS before relapse : 0 to 5
- relapse : increase of 1 point or more for 1 or more functional systems of Kurtzke, with SF score most affected \> 1 for all functions except for sensory (\> 2); duration of symptoms \> 24 h
Exclusion
- fever
- previous relapse, and/or corticosteroid treatment \< 1 month before present relapse
- first symptoms of the present relapse appeared \> 15 days before inclusion
- under mitoxantrone of cyclophosphamid or natalizumab treatment
- diabetes
- infection not under control
- liver or kidney failure
- psychiatric symptoms not under control
- pregnancy
- hypersensibility to methylprednisolone
Key Trial Info
Start Date :
March 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2014
Estimated Enrollment :
200 Patients enrolled
Trial Details
Trial ID
NCT00984984
Start Date
March 1 2008
End Date
June 1 2014
Last Update
December 5 2012
Active Locations (14)
Enter a location and click search to find clinical trials sorted by distance.
1
Hôpital des Armées
Brest, France, 29249
2
CHU Cavale Blanche
Brest, France, 29609
3
Centre Hospitalier de Vendée
La Roche-sur-Yon, France, 85000
4
Centre Hospitalier de Lannion
Lannion, France, 22300