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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified December 2012 by Rennes University Hospital.
Recruitment status was:  Recruiting
Information provided by (Responsible Party):
Rennes University Hospital Identifier:
First received: September 24, 2009
Last updated: December 4, 2012
Last verified: December 2012
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 Intervention Phase
Multiple Sclerosis, Relapsing-Remitting Drug: methylprednisolone PO Drug: methylprednisolone IV Phase 3

Study Type: Interventional
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Rennes University Hospital:

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

Estimated Enrollment: 200
Study Start Date: March 2008
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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


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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00984984

Contact: Emmanuelle LE PAGE, MD 33-2-9928-5296
Contact: Veronique DEBURGHGRAEVE, MD 33-2-9928-89038

Hôpital des Armées Recruiting
Brest, France, 29249
Contact: zagnoli   
CHU Cavale Blanche Recruiting
Brest, France, 29609
Contact: Rouhart   
Centre Hospitalier de Vendée Recruiting
La Roche sur Yon, France, 85000
Contact: de marco   
Centre Hospitalier de Lannion Recruiting
Lannion, France, 22300
Contact: Massengo   
Centre hospitalier Bretagne Sud Recruiting
Lorient, France, 56100
Contact: Sartori   
CHU Laennec Recruiting
Nantes, France, 44000
Contact: Laplaud   
Contact: Wiertlewski   
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   
CH de Cornouaille Recruiting
Quimper, France, 29000
Contact: coustans   
Hôpital de Cornouaille Recruiting
Quimper, France, 29000
Contact: Coustans   
Rennes University Hospital Recruiting
Rennes, France, 35033
Contact: Le Page   
Hopital Yves Le Foll Recruiting
Saint Brieuc, France, 22023
Contact: Lallement   
CH Saint Malo Recruiting
Saint Malo, France, 35400
Contact: taurin   
Centre Hospitalier Bretagne Atlantique Recruiting
Vannes, France, 56000
Contact: Kassiotis   
Sponsors and Collaborators
Rennes University Hospital
Principal Investigator: Emmanuelle Le Page, MD Rennes University Hospital
  More Information

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Rennes University Hospital Identifier: NCT00984984     History of Changes
Other Study ID Numbers: 2007-000590-37
Study First Received: September 24, 2009
Last Updated: December 4, 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 processed this record on September 19, 2017