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| ID | Type | Description | Link |
|---|---|---|---|
| ESP/07-09 |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| methylprednisolone PO | Experimental |
| |
| methylprednisolone IV | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| methylprednisolone PO | Drug | 10 capsules Methylprednisolone 100 mg and 50 ml IV NaCl 0,9% (syringe pump 30 mn to 2 h, every day during 3 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| At least 1 point-reduction on Kurtzke functional scale | 28 days after beginning of corticotherapy |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Emmanuelle LE PAGE, MD | Contact | 33-2-9928-5296 | emmanuelle.lepage@chu-rennes.fr | |
| Veronique DEBURGHGRAEVE, MD | Contact | 33-2-9928-89038 | veronique.deburghgraeve@chu-rennes.fr |
| Name | Affiliation | Role |
|---|---|---|
| Emmanuelle Le Page, MD | Rennes University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hôpital des Armées | Recruiting | Brest | 29249 | France |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 26135706 | Derived | 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. |
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| methylprednisolone IV | Drug | 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 |
|
| CHU Cavale Blanche | Recruiting | Brest | 29609 | France |
|
| Centre Hospitalier de Vendée | Recruiting | La Roche-sur-Yon | 85000 | France |
|
| Centre Hospitalier de Lannion | Recruiting | Lannion | 22300 | France |
|
| Centre hospitalier Bretagne Sud | Recruiting | Lorient | 56100 | France |
|
| CHU Laennec | Recruiting | Nantes | 44000 | France |
|
| Hôpital La pitié Salpétriere | Recruiting | Paris | 75651 cedex 13 | France |
|
| Centre Hospitalier de Pontivy | Recruiting | Pontivy | 56300 | France |
|
| CH de Cornouaille | Recruiting | Quimper | 29000 | France |
|
| Hôpital de Cornouaille | Recruiting | Quimper | 29000 | France |
|
| Rennes University Hospital | Recruiting | Rennes | 35033 | France |
|
| Hopital Yves Le Foll | Recruiting | Saint-Brieuc | 22023 | France |
|
| CH Saint Malo | Recruiting | St-Malo | 35400 | France |
|
| Centre Hospitalier Bretagne Atlantique | Recruiting | Vannes | 56000 | France |
|
| ID | Term |
|---|---|
| D020529 | Multiple Sclerosis, Relapsing-Remitting |
| ID | Term |
|---|---|
| D009103 | Multiple Sclerosis |
| D020278 | Demyelinating Autoimmune Diseases, CNS |
| D020274 | Autoimmune Diseases of the Nervous System |
| D009422 | Nervous System Diseases |
| D003711 | Demyelinating Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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| ID | Term |
|---|---|
| D008775 | Methylprednisolone |
| ID | Term |
|---|---|
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
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