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Status unknownNCT00984984COPOUSEPUpdated Dec 5, 2012

Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses

A Phase 3 interventional study of methylprednisolone PO and methylprednisolone IV in Multiple Sclerosis, Relapsing-Remitting, sponsored by Rennes University Hospital. Status unknown at 14 sites in France. Open to participants aged 18 Years to 55 Years. Per ClinicalTrials.gov, last updated 2012-12-05.

Sponsored by Rennes University Hospital · Phase 3, Interventional, and Treatment

The sponsor has not verified this record recently (last verified Dec 2012), so the status shown — last known as Recruiting — may be out of date.
Phase
Phase 3
Study type
Interventional
Enrollment
200
Allocation
Randomized
Ages
18 Years to 55 Years
Sex
All
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Study summary

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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Conditions studied

  • Multiple Sclerosis, Relapsing-Remitting
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In context

Multiple Sclerosis

3,460 studies on the registry are indexed under Multiple Sclerosis; 661 are open to participants now.

This study's planned enrollment of 200 is above the median of 50 across 2,342 interventional studies indexed under Multiple Sclerosis.

Browse Multiple Sclerosis studies →

Lead sponsor

Rennes University Hospital is the lead sponsor of 440 studies on the registry; 51 are open to participants now.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years to 55 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Triple (Participant, Care provider, Investigator)
Enrollment
200 participants (estimated)

Study arms

  • Experimental
    methylprednisolone PO

    Drug: methylprednisolone PO

  • Active comparator
    methylprednisolone IV

    Drug: methylprednisolone IV

Interventions

  • Drugmethylprednisolone 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

  • Drugmethylprednisolone 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

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What researchers measure

Primary outcomes

  1. At least 1 point-reduction on Kurtzke functional scale

    Time frame: 28 days after beginning of corticotherapy

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Study locations

14 of 14 sites recruiting
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References and documents

Publications

  • 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. Erratum In: Lancet. 2016 Jan 23;387(10016):340. doi: 10.1016/S0140-6736(16)00096-9. PubMed 26135706 ↗
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 5, 2012, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT00984984
Lead sponsor
Rennes University Hospital
Responsible party
Sponsor
First posted
Sep 25, 2009
Start date
Mar 2008
Primary completion
Jun 2013 (estimated)
Completion
Jun 2014 (estimated)
Last update
Dec 5, 2012

Study contacts

Emmanuelle LE PAGE, MD
Contact
emmanuelle.lepage@chu-rennes.fr
33-2-9928-5296
Veronique DEBURGHGRAEVE, MD
Contact
veronique.deburghgraeve@chu-rennes.fr
33-2-9928-89038
Emmanuelle Le Page, MD
principal investigator · Rennes University Hospital

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Dec 2012. You cannot join it, but the record below documents what was studied.

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