Clinical trial NCT00984984: Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses
Official title: Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: PHASE3
Conditions: Multiple Sclerosis, Relapsing-Remitting
Lead sponsor: Rennes University Hospital
Sponsor class: OTHER
First posted: 2009-09-25
Enrollment: 200
Sex: ALL
Minimum age (years): 18
Maximum age (years): 55
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


Eligibility 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

Primary outcomes:
measure: At least 1 point-reduction on Kurtzke functional scale
timeFrame: 28 days after beginning of corticotherapy
Secondary outcomes:
Other outcomes:
Locations:
city: Brest
country: France
facility: Hôpital des Armées
city: Brest
country: France
facility: CHU Cavale Blanche
city: La Roche sur Yon
country: France
facility: Centre Hospitalier de Vendée
city: Lannion
country: France
facility: Centre Hospitalier de Lannion
city: Lorient
country: France
facility: Centre hospitalier Bretagne Sud
city: Nantes
country: France
facility: CHU Laennec
city: Paris
country: France
facility: Hôpital La pitié Salpétriere
city: Pontivy
country: France
facility: Centre Hospitalier de Pontivy
city: Quimper
country: France
facility: CH de Cornouaille
city: Quimper
country: France
facility: Hôpital de Cornouaille
city: Rennes
country: France
facility: Rennes University Hospital
city: Saint Brieuc
country: France
facility: Hopital Yves Le Foll
city: Saint Malo
country: France
facility: CH Saint Malo
city: Vannes
country: France
facility: Centre Hospitalier Bretagne Atlantique
Study officials:
affiliation: Rennes University Hospital
name: Emmanuelle Le Page, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Le Page E, Veillard D, Laplaud DA, Hamonic S, Wardi R, Lebrun C, Zagnoli F, Wiertlewski S, Deburghgraeve V, Coustans M, Edan G; COPOUSEP investigators; West Network for Excellence in Neuroscience. Oral versus intravenous high-dose methylprednisolone for treatment of relapses in patients with multiple sclerosis (COPOUSEP): a randomised, controlled, double-blind, non-inferiority trial. Lancet. 2015 Sep 5;386(9997):974-81. doi: 10.1016/S0140-6736(15)61137-0. Epub 2015 Jun 28.