Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses (COPOUSEP)
This study is currently recruiting participants.
Verified December 2012 by Rennes University Hospital
Sponsor:
Rennes University Hospital
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
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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:
Genetics Home Reference related topics:
multiple sclerosis
MedlinePlus related topics:
Multiple Sclerosis
Drug Information available for:
Prednisolone
Prednisolone acetate
Methylprednisolone acetate
Methylprednisolone
Prednisolone sodium phosphate
Prednisolone phosphate
Prednisolone sodium succinate
Methylprednisolone sodium succinate
U.S. FDA Resources
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
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 | CHU de Rennes |
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 May 21, 2013