Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses
NCT ID: NCT00984984
Last Updated: 2012-12-05
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
PHASE3
200 participants
INTERVENTIONAL
2008-03-31
2014-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
TRIPLE
Study Groups
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methylprednisolone PO
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
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
Interventions
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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
Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
55 Years
ALL
No
Sponsors
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Rennes University Hospital
OTHER
Responsible Party
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Principal Investigators
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Emmanuelle Le Page, MD
Role: PRINCIPAL_INVESTIGATOR
Rennes University Hospital
Locations
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Hôpital des Armées
Brest, , France
CHU Cavale Blanche
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
St-Malo, , France
Centre Hospitalier Bretagne Atlantique
Vannes, , France
Countries
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Central Contacts
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Facility Contacts
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zagnoli
Role: primary
Rouhart
Role: primary
de marco
Role: primary
Massengo
Role: primary
Sartori
Role: primary
Laplaud
Role: primary
Wiertlewski
Role: backup
Papeix
Role: primary
Anani
Role: primary
coustans
Role: primary
Coustans
Role: primary
Le Page
Role: primary
Lallement
Role: primary
taurin
Role: primary
Kassiotis
Role: primary
References
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Le Page E, Veillard D, Laplaud DA, Hamonic S, Wardi R, Lebrun C, Zagnoli F, Wiertlewski S, Deburghgraeve V, Coustans M, Edan G; COPOUSEP investigators; West Network for Excellence in Neuroscience. Oral versus intravenous high-dose methylprednisolone for treatment of relapses in patients with multiple sclerosis (COPOUSEP): a randomised, controlled, double-blind, non-inferiority trial. Lancet. 2015 Sep 5;386(9997):974-81. doi: 10.1016/S0140-6736(15)61137-0. Epub 2015 Jun 28.
Other Identifiers
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ESP/07-09
Identifier Type: -
Identifier Source: secondary_id
2007-000590-37
Identifier Type: -
Identifier Source: org_study_id