Informations générales (source: ClinicalTrials.gov)
Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses (COPOUSEP)
Interventional
Phase 3
Rennes University Hospital (Voir sur ClinicalTrials)
mars 2008
juin 2014
29 juin 2024
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.
Etablissements
| Les établissements hors Île-de-France dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
|---|---|---|---|---|---|
| Centre Hospitalier Bretagne Atlantique - 56000 - Vannes - France | Kassiotis | Contact (sur clinicalTrials) | |||
| Centre hospitalier Bretagne Sud - 56100 - Lorient - France | Sartori | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Lannion - 22300 - Lannion - France | Massengo | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Pontivy - 56300 - Pontivy - France | Anani | Contact (sur clinicalTrials) | |||
| Centre Hospitalier de Vendée - 85000 - La Roche sur Yon - France | de marco | Contact (sur clinicalTrials) | |||
| CH de Cornouaille - 29000 - Quimper - France | coustans | Contact (sur clinicalTrials) | |||
| CHU Laennec - 44000 - Nantes - France | Laplaud | Contact (sur clinicalTrials) | |||
| Hôpital des Armées - 29249 - Brest - France | zagnoli | Contact (sur clinicalTrials) | |||
| Hopital Yves Le Foll - 22023 - Saint Brieuc - France | Lallement | Contact (sur clinicalTrials) | |||
| Les établissements sans correspondance certaine dans le répertoire FINESS dont les données sont issues de ClinicalTrials.gov Origine et niveau de fiabilité des données | |||||
| CH Saint Malo - 35400 - Saint Malo - France | taurin | Contact (sur clinicalTrials) | |||
| CHU Cavale Blanche - 29609 - Brest - France | Rouhart | Contact (sur clinicalTrials) | |||
| Hôpital de Cornouaille - 29000 - Quimper - France | Coustans | Contact (sur clinicalTrials) | |||
| Hôpital La pitié Salpétriere - 75651 cedex 13 - Paris - France | Papeix | Contact (sur clinicalTrials) | |||
| Rennes University Hospital - 35033 - Rennes - France | Le Page | Contact (sur clinicalTrials) | |||
Critères
Tous
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
- 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
- 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