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

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.

Timeline

Start

2008-03

Primary completion

2013-06

Completion

2014-06

Outcome

Met primary endpoint

paper achieved the primary endpoint (absolute treatment difference 0·5%, 90% CI -9·5 to 10·4). PMID 26135706 ↗

paper Oral administration of high-dose methylprednisolone for 3 days was not inferior to intravenous administration PMID 26135706 ↗

Publications

• 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.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Methylprednisolone	Other / unclassified	1000 mg	Oral

Indications