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

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Rennes University Hospital
Sponsor:
Information provided by (Responsible Party):
Rennes University Hospital
ClinicalTrials.gov Identifier:
NCT00984984
First received: September 24, 2009
Last updated: December 4, 2012
Last verified: December 2012
  Purpose

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
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, 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 ] [ Designated as safety issue: No ]

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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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 ClinicalTrials.gov identifier: NCT00984984

Contacts
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

Locations
France
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
Investigators
Principal Investigator: Emmanuelle Le Page, MD Rennes University Hospital
  More Information

No publications provided

Responsible Party: Rennes University Hospital
ClinicalTrials.gov Identifier: NCT00984984     History of Changes
Other Study ID Numbers: 2007-000590-37, ESP/07-09
Study First Received: September 24, 2009
Last Updated: December 4, 2012
Health Authority: France: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)

Additional relevant MeSH terms:
Multiple Sclerosis
Sclerosis
Multiple Sclerosis, Relapsing-Remitting
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases
Pathologic Processes
Methylprednisolone acetate
Prednisolone acetate
Methylprednisolone
Methylprednisolone Hemisuccinate
Prednisolone
Prednisolone hemisuccinate
Prednisolone phosphate
Anti-Inflammatory Agents
Therapeutic Uses
Pharmacologic Actions
Antiemetics
Autonomic Agents
Peripheral Nervous System Agents
Physiological Effects of Drugs
Central Nervous System Agents
Gastrointestinal Agents
Neuroprotective Agents
Protective Agents
Glucocorticoids
Hormones

ClinicalTrials.gov processed this record on July 22, 2014