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

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ClinicalTrials.gov Identifier: NCT00984984
Recruitment Status : Unknown
Verified December 2012 by Rennes University Hospital.
Recruitment status was:  Recruiting
First Posted : September 25, 2009
Last Update Posted : December 5, 2012
Information provided by (Responsible Party):
Rennes University Hospital

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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis, Relapsing-Remitting Drug: methylprednisolone PO Drug: methylprednisolone IV Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 200 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses
Study Start Date : March 2008
Estimated Primary Completion Date : June 2013
Estimated Study Completion Date : June 2014

Arm Intervention/treatment
Experimental: methylprednisolone PO 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
Active Comparator: methylprednisolone IV 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

Primary Outcome Measures :
  1. At least 1 point-reduction on Kurtzke functional scale [ Time Frame: 28 days after beginning of corticotherapy ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00984984

Contact: Emmanuelle LE PAGE, MD 33-2-9928-5296 emmanuelle.lepage@chu-rennes.fr
Contact: Veronique DEBURGHGRAEVE, MD 33-2-9928-89038 veronique.deburghgraeve@chu-rennes.fr

Hôpital des Armées Recruiting
Brest, France, 29249
Contact: zagnoli       fabien.zagnoli@wanaddo.fr   
CHU Cavale Blanche Recruiting
Brest, France, 29609
Contact: Rouhart       francois.rouhart@chu-brest.fr   
Centre Hospitalier de Vendée Recruiting
La Roche sur Yon, France, 85000
Contact: de marco       olivier.demarco@chd-vendee.fr   
Centre Hospitalier de Lannion Recruiting
Lannion, France, 22300
Contact: Massengo       serge.massengo@wanadoo.fr   
Centre hospitalier Bretagne Sud Recruiting
Lorient, France, 56100
Contact: Sartori       e.sartori@ch-bretagne-sud.fr   
CHU Laennec Recruiting
Nantes, France, 44000
Contact: Laplaud       david.laplaud@chu-nantes.fr   
Contact: Wiertlewski       sandrine.wiertlewski@chu-nantes.fr   
Hôpital La pitié Salpétriere Recruiting
Paris, France, 75651 cedex 13
Contact: Papeix    33 1 42 16 17 51      
Centre Hospitalier de Pontivy Recruiting
Pontivy, France, 56300
Contact: Anani       thierry.anani@ch-pontivy.fr   
CH de Cornouaille Recruiting
Quimper, France, 29000
Contact: coustans       m.coustans@ch-cornouaille.fr   
Hôpital de Cornouaille Recruiting
Quimper, France, 29000
Contact: Coustans       m.coustans@ch-cornouaille.fr   
Rennes University Hospital Recruiting
Rennes, France, 35033
Contact: Le Page       emmanuelle.lepage@chu-rennes.fr   
Hopital Yves Le Foll Recruiting
Saint Brieuc, France, 22023
Contact: Lallement       francois.lallement@ch-stbrieuc.fr   
CH Saint Malo Recruiting
Saint Malo, France, 35400
Contact: taurin       g.taurin@ch-stmalo.fr   
Centre Hospitalier Bretagne Atlantique Recruiting
Vannes, France, 56000
Contact: Kassiotis       philippe.kassiotis@ch-bretagne-atlantique.fr   
Sponsors and Collaborators
Rennes University Hospital
Principal Investigator: Emmanuelle Le Page, MD Rennes University Hospital

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00984984     History of Changes
Other Study ID Numbers: 2007-000590-37
First Posted: September 25, 2009    Key Record Dates
Last Update Posted: December 5, 2012
Last Verified: December 2012

Additional relevant MeSH terms:
Multiple Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone Hemisuccinate
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Gastrointestinal Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Neuroprotective Agents
Protective Agents
Antineoplastic Agents, Hormonal
Antineoplastic Agents