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

Phase 3

• Conditions: Multiple Sclerosis, Relapsing-Remitting
• Interventions: Drug: methylprednisolone PO; Drug: methylprednisolone IV

• Registration Number: NCT00984984
• Lead Sponsor: Rennes University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-03
• Study First Submitted: 2009-09-24
• Study First Submitted QC: 2009-09-24
• Study First Posted: 2009-09-25
• Status Verified: 2012-12
• Last Update Submitted: 2012-12-04
• Last Update Posted: 2012-12-05
• Primary Completion: 2013-06
• Study Completion: 2014-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 200

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
methylprednisolone PO	methylprednisolone PO	-
methylprednisolone IV	methylprednisolone IV	-

Primary Outcome Measures

Name	Time	Method
At least 1 point-reduction on Kurtzke functional scale	28 days after beginning of corticotherapy

Trial Locations

Locations (14)

Hôpital de Cornouaille; 🇫🇷 Quimper, France

Centre Hospitalier de Vendée; 🇫🇷 La Roche sur Yon, France

Hôpital des Armées; 🇫🇷 Brest, France

Centre hospitalier Bretagne Sud; 🇫🇷 Lorient, France

Hôpital La pitié Salpétriere; 🇫🇷 Paris, France

Centre Hospitalier de Lannion; 🇫🇷 Lannion, France

CHU Cavale Blanche; 🇫🇷 Brest, France

CHU Laennec; 🇫🇷 Nantes, France

Centre Hospitalier de Pontivy; 🇫🇷 Pontivy, France

CH de Cornouaille; 🇫🇷 Quimper, France

Hopital Yves Le Foll; 🇫🇷 Saint Brieuc, France

Centre Hospitalier Bretagne Atlantique; 🇫🇷 Vannes, France

Rennes University Hospital; 🇫🇷 Rennes, France

CH Saint Malo; 🇫🇷 Saint Malo, France