Efficacy and Safety of Methylprednisolone Per os Versus IV for the Tre
Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses
What it found
The trial was designed to show the treatment was not worse than another, and it did.
“In the per-protocol population, 66 (81%) of 82 patients in the oral group and 72 (80%) of 90 patients in the intravenous group achieved the primary endpoint (absolute treatment difference 0·5%, 90% CI -9·5 to 10·4).”Read by software from the paper's abstract
Proportion of patients who had improved by day 28 (decrease of at least one point in most affected score on Kurtzke Functional System Scale), without need for retreatment with corticosteroids, in the per-protocol population · day 28
| Group | n | Value |
|---|---|---|
| Oral methylprednisolone | 82 | 66 (81%) |
| Intravenous methylprednisolone | 90 | 72 (80%) |
absolute treatment difference 0.5% (95% CI -9.5–10.4)
Total participants: 199
Read by software from the paper's abstract
What was tested
Treatment tested
- methylprednisolone PO
- Methylprednisolone
Glucocorticoid receptor agonist
Compared with
- Methylprednisolone
Glucocorticoid receptor agonist
What it measured
Main measures
At least 1 point-reduction on Kurtzke functional scale
28 days after beginning of corticotherapy
- Critère de jugement principal de l’étude : l’absence d’infériorité de la voie orale par rapport à la voie intraveineuse sera retenue si le pourcentage de patients améliorés 28 jours après l’inclusion ne diffère pas de plus de 15 % entre les 2 groupes.
Who could take part
Relapsing MS · 18 to 55 · EDSS 0 to 5
Show the full 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
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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
In the per-protocol population, 66 (81%) of 82 patients in the oral group and 72 (80%) of 90 patients in the intravenous group achieved the primary endpoint (absolute treatment difference 0·5%, 90% CI -9·5 to 10·4).
Read by software from the paper's abstract
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History
Started
Mar 2008
Main results due
Jun 2013
Finished
Jun 2014