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

Condition(s) targeted: Multiple Sclerosis, Relapsing-Remitting

Intervention: methylprednisolone PO (Drug); methylprednisolone IV (Drug)

Phase: Phase 3

Status: Recruiting

Sponsored by: Rennes University Hospital

Official(s) and/or principal investigator(s):
Emmanuelle Le Page, MD, Principal Investigator, Affiliation: Rennes University Hospital

Overall contact:
Emmanuelle LE PAGE, MD, Phone: 33-2-9928-5296, Email: emmanuelle.lepage@chu-rennes.fr

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.

Official title: Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses

Study design: Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator), Primary Purpose: Treatment

Primary outcome: At least 1 point-reduction on Kurtzke functional scale

Minimum age: 18 Years. Maximum age: 55 Years. Gender(s): Both.

Criteria:

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

Emmanuelle LE PAGE, MD, Phone: 33-2-9928-5296, Email: emmanuelle.lepage@chu-rennes.fr

CHU Cavale Blanche, Brest 29609, France; Recruiting
Rouhart, Email: francois.rouhart@chu-brest.fr

Hôpital des Armées, Brest 29249, France; Recruiting
zagnoli, Email: fabien.zagnoli@wanaddo.fr

Centre Hospitalier de Vendée, La Roche sur Yon 85000, France; Recruiting
de marco, Email: olivier.demarco@chd-vendee.fr

Centre Hospitalier de Lannion, Lannion 22300, France; Recruiting
Massengo, Email: serge.massengo@wanadoo.fr

Centre hospitalier Bretagne Sud, Lorient 56100, France; Recruiting
Sartori, Email: e.sartori@ch-bretagne-sud.fr

CHU Laennec, Nantes 44000, France; Recruiting
Laplaud, Email: david.laplaud@chu-nantes.fr
Wiertlewski, Email: sandrine.wiertlewski@chu-nantes.fr

Hôpital La pitié Salpétriere, Paris 75651 cedex 13, France; Recruiting
Papeix, Phone: 33 1 42 16 17 51

Centre Hospitalier de Pontivy, Pontivy 56300, France; Recruiting
Anani, Email: thierry.anani@ch-pontivy.fr

CH de Cornouaille, Quimper 29000, France; Recruiting
coustans, Email: m.coustans@ch-cornouaille.fr

Hôpital de Cornouaille, Quimper 29000, France; Recruiting
Coustans, Email: m.coustans@ch-cornouaille.fr

Rennes University Hospital, Rennes 35033, France; Recruiting
Le Page, Email: emmanuelle.lepage@chu-rennes.fr

Hopital Yves Le Foll, Saint Brieuc 22023, France; Recruiting
Lallement, Email: francois.lallement@ch-stbrieuc.fr

CH Saint Malo, Saint Malo 35400, France; Recruiting
taurin, Email: g.taurin@ch-stmalo.fr

Centre Hospitalier Bretagne Atlantique, Vannes 56000, France; Recruiting
Kassiotis, Email: philippe.kassiotis@ch-bretagne-atlantique.fr

Starting date: March 2008
Last updated: December 4, 2012