Multiple Sclerosis, Relapsing-Remitting
Conditions
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 study is to check if the efficacy of high dose oral methylprednisolone is similar to the efficacy intravenous (IV) prednisolone. The main criteria of efficacy is symptom recovery within 28 days after inclusion.
Interventions
DRUGmethylprednisolone PO
10 capsules Methylprednisolone 100 mg and 50 ml IV NaCl 0,9% (syringe pump 30 mn to 2 h, every day during 3 days
IV Methylprednisolone 1 g in 50 ml NaCl 0,9% (syringe pump 30 mn to 2 h) and 10 capsules of placebo, every day during 3 days
Sponsors
Rennes University Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Eligibility
Sex/Gender
ALL
Age
18 Years to 55 Years
Healthy volunteers
No
Inclusion criteria
* 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 criteria
* 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| At least 1 point-reduction on Kurtzke functional scale | 28 days after beginning of corticotherapy |
Countries
France
Contacts
Primary ContactEmmanuelle LE PAGE, MD
Backup ContactVeronique DEBURGHGRAEVE, MD
Outcome results
None listed