NCT00984984

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

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

• Status: Unknown
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 200 (estimated)
• Sponsor: Rennes University Hospital · Academic / Other
• Sex: All
• Age: 18 Years – 55 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Multiple Sclerosis, Relapsing-Remitting

Interventions

Type	Name	Description
DRUG	methylprednisolone PO	10 capsules Methylprednisolone 100 mg and 50 ml IV NaCl 0,9% (syringe pump 30 mn to 2 h, every day during 3 days
DRUG	methylprednisolone IV	IV Methylprednisolone 1 g in 50 ml NaCl 0,9% (syringe pump 30 mn to 2 h) and 10 capsules of placebo, every day during 3 days

Timeline

• Start date: 2008-03-01
• Primary completion: 2013-06-01
• Completion: 2014-06-01
• First posted: 2009-09-25
• Last updated: 2012-12-05

Locations

14 sites across 1 country: France