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

Multiple Sclerosis, Relapsing-Remitting Clinical Trial

— COPOUSEP  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT00984984
• Other study ID #: 2007-000590-37
• Secondary ID: ESP/07-09
• Status: Recruiting
• Phase: Phase 3
• First received: September 24, 2009
• Last updated: December 4, 2012
• Start date: March 2008
• Est. completion date: June 2014

Study information

• Verified date: December 2012
• Source: Rennes University Hospital
• Contact: Emmanuelle LE PAGE, MD
• Phone: 33-2-9928-5296
• Email: emmanuelle.lepage[@]chu-rennes.fr
• Is FDA regulated: No
• Health authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: June 2014
• Est. primary completion date: June 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Multiple Sclerosis, Relapsing-Remitting
• Sclerosis

Intervention

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
• 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

Locations

Country	Name	City	State
France	CHU Cavale Blanche	Brest
France	Hôpital des Armées	Brest
France	Centre Hospitalier de Vendée	La Roche sur Yon
France	Centre Hospitalier de Lannion	Lannion
France	Centre hospitalier Bretagne Sud	Lorient
France	CHU Laennec	Nantes
France	Hôpital La pitié Salpétriere	Paris
France	Centre Hospitalier de Pontivy	Pontivy
France	CH de Cornouaille	Quimper
France	Hôpital de Cornouaille	Quimper
France	Rennes University Hospital	Rennes
France	Hopital Yves Le Foll	Saint Brieuc
France	CH Saint Malo	Saint Malo
France	Centre Hospitalier Bretagne Atlantique	Vannes

Sponsors (1)

Lead Sponsor	Collaborator
Rennes University Hospital

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	At least 1 point-reduction on Kurtzke functional scale		28 days after beginning of corticotherapy	No