Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses (COPOUSEP)

Rennes University Hospital

Status and phase

Unknown

Phase 3

Conditions

Multiple Sclerosis, Relapsing-Remitting

Treatments

Drug: methylprednisolone IV

Drug: methylprednisolone PO

Study type

Interventional

Funder types

Other

Identifiers

NCT00984984

2007-000590-37

ESP/07-09

Details and patient eligibility

About

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.

Enrollment

200 estimated patients

Sex

All

Ages

18 to 55 years old

Volunteers

No Healthy Volunteers

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