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

Primary Purpose

Multiple Sclerosis, Relapsing-Remitting

Status
Unknown status
Phase
Phase 3
Locations
France
Study Type
Interventional
Intervention
methylprednisolone PO
methylprednisolone IV
Sponsored by
Rennes University Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Multiple Sclerosis, Relapsing-Remitting

Eligibility Criteria

18 Years - 55 Years (Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Hôpital des ArméesRecruiting
  • CHU Cavale BlancheRecruiting
  • Centre Hospitalier de VendéeRecruiting
  • Centre Hospitalier de LannionRecruiting
  • Centre hospitalier Bretagne SudRecruiting
  • CHU LaennecRecruiting
  • Hôpital La pitié SalpétriereRecruiting
  • Centre Hospitalier de PontivyRecruiting
  • CH de CornouailleRecruiting
  • Hôpital de CornouailleRecruiting
  • Rennes University HospitalRecruiting
  • Hopital Yves Le FollRecruiting
  • CH Saint MaloRecruiting
  • Centre Hospitalier Bretagne AtlantiqueRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

methylprednisolone PO

methylprednisolone IV

Arm Description

Outcomes

Primary Outcome Measures

At least 1 point-reduction on Kurtzke functional scale

Secondary Outcome Measures

Full Information

First Posted
September 24, 2009
Last Updated
December 4, 2012
Sponsor
Rennes University Hospital
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1. Study Identification

Unique Protocol Identification Number
NCT00984984
Brief Title
Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses
Acronym
COPOUSEP
Official Title
Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses
Study Type
Interventional

2. Study Status

Record Verification Date
December 2012
Overall Recruitment Status
Unknown status
Study Start Date
March 2008 (undefined)
Primary Completion Date
June 2013 (Anticipated)
Study Completion Date
June 2014 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Rennes University Hospital

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis, Relapsing-Remitting

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
200 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
methylprednisolone PO
Arm Type
Experimental
Arm Title
methylprednisolone IV
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
methylprednisolone PO
Intervention Description
10 capsules Methylprednisolone 100 mg and 50 ml IV NaCl 0,9% (syringe pump 30 mn to 2 h, every day during 3 days
Intervention Type
Drug
Intervention Name(s)
methylprednisolone IV
Intervention Description
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
Primary Outcome Measure Information:
Title
At least 1 point-reduction on Kurtzke functional scale
Time Frame
28 days after beginning of corticotherapy

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
55 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Emmanuelle LE PAGE, MD
Phone
33-2-9928-5296
Email
emmanuelle.lepage@chu-rennes.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Veronique DEBURGHGRAEVE, MD
Phone
33-2-9928-89038
Email
veronique.deburghgraeve@chu-rennes.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Emmanuelle Le Page, MD
Organizational Affiliation
Rennes University Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hôpital des Armées
City
Brest
ZIP/Postal Code
29249
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
zagnoli
Email
fabien.zagnoli@wanaddo.fr
Facility Name
CHU Cavale Blanche
City
Brest
ZIP/Postal Code
29609
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rouhart
Email
francois.rouhart@chu-brest.fr
Facility Name
Centre Hospitalier de Vendée
City
La Roche sur Yon
ZIP/Postal Code
85000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
de marco
Email
olivier.demarco@chd-vendee.fr
Facility Name
Centre Hospitalier de Lannion
City
Lannion
ZIP/Postal Code
22300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massengo
Email
serge.massengo@wanadoo.fr
Facility Name
Centre hospitalier Bretagne Sud
City
Lorient
ZIP/Postal Code
56100
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sartori
Email
e.sartori@ch-bretagne-sud.fr
Facility Name
CHU Laennec
City
Nantes
ZIP/Postal Code
44000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laplaud
Email
david.laplaud@chu-nantes.fr
First Name & Middle Initial & Last Name & Degree
Wiertlewski
Email
sandrine.wiertlewski@chu-nantes.fr
Facility Name
Hôpital La pitié Salpétriere
City
Paris
ZIP/Postal Code
75651 cedex 13
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Papeix
Phone
33 1 42 16 17 51
Facility Name
Centre Hospitalier de Pontivy
City
Pontivy
ZIP/Postal Code
56300
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anani
Email
thierry.anani@ch-pontivy.fr
Facility Name
CH de Cornouaille
City
Quimper
ZIP/Postal Code
29000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
coustans
Email
m.coustans@ch-cornouaille.fr
Facility Name
Hôpital de Cornouaille
City
Quimper
ZIP/Postal Code
29000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Coustans
Email
m.coustans@ch-cornouaille.fr
Facility Name
Rennes University Hospital
City
Rennes
ZIP/Postal Code
35033
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Le Page
Email
emmanuelle.lepage@chu-rennes.fr
Facility Name
Hopital Yves Le Foll
City
Saint Brieuc
ZIP/Postal Code
22023
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Lallement
Email
francois.lallement@ch-stbrieuc.fr
Facility Name
CH Saint Malo
City
Saint Malo
ZIP/Postal Code
35400
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
taurin
Email
g.taurin@ch-stmalo.fr
Facility Name
Centre Hospitalier Bretagne Atlantique
City
Vannes
ZIP/Postal Code
56000
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kassiotis
Email
philippe.kassiotis@ch-bretagne-atlantique.fr

12. IPD Sharing Statement

Citations:
PubMed Identifier
26135706
Citation
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.
Results Reference
derived

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

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