NCT00984984

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
200

participants targeted

Target at P25-P50 for phase_3

Timeline
Completed

Started Mar 2008

Longer than P75 for phase_3

Geographic Reach
1 country

14 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2008

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

September 24, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

September 25, 2009

Completed
3.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2013

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2014

Completed
Last Updated

December 5, 2012

Status Verified

December 1, 2012

Enrollment Period

5.3 years

First QC Date

September 24, 2009

Last Update Submit

December 4, 2012

Conditions

Multiple Sclerosis, Relapsing-Remitting

Outcome Measures

Primary Outcomes (1)

  • At least 1 point-reduction on Kurtzke functional scale

    28 days after beginning of corticotherapy

Study Arms (2)

methylprednisolone PO

EXPERIMENTAL
Drug: methylprednisolone PO

methylprednisolone IV

ACTIVE COMPARATOR
Drug: methylprednisolone IV

Interventions

methylprednisolone PODRUG

10 capsules Methylprednisolone 100 mg and 50 ml IV NaCl 0,9% (syringe pump 30 mn to 2 h, every day during 3 days

methylprednisolone PO
methylprednisolone IVDRUG

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

methylprednisolone IV

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • fever
  • previous relapse, and/or corticosteroid treatment \< 1 month before present relapse
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (14)

Hôpital des Armées

Brest, 29249, France

RECRUITING

CHU Cavale Blanche

Brest, 29609, France

RECRUITING

Centre Hospitalier de Vendée

La Roche-sur-Yon, 85000, France

RECRUITING

Centre Hospitalier de Lannion

Lannion, 22300, France

RECRUITING

Centre hospitalier Bretagne Sud

Lorient, 56100, France

RECRUITING

CHU Laennec

Nantes, 44000, France

RECRUITING

Hôpital La pitié Salpétriere

Paris, 75651 cedex 13, France

RECRUITING

Centre Hospitalier de Pontivy

Pontivy, 56300, France

RECRUITING

CH de Cornouaille

Quimper, 29000, France

RECRUITING

Hôpital de Cornouaille

Quimper, 29000, France

RECRUITING

Rennes University Hospital

Rennes, 35033, France

RECRUITING

Hopital Yves Le Foll

Saint-Brieuc, 22023, France

RECRUITING

CH Saint Malo

St-Malo, 35400, France

RECRUITING

Centre Hospitalier Bretagne Atlantique

Vannes, 56000, France

RECRUITING

Related Publications (1)

  • 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.

    PMID: 26135706DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Methylprednisolone

Condition Hierarchy (Ancestors)

Multiple SclerosisDemyelinating Autoimmune Diseases, CNSAutoimmune Diseases of the Nervous SystemNervous System DiseasesDemyelinating DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

PrednisolonePregnadienetriolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Emmanuelle Le Page, MD

    Rennes University Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Emmanuelle LE PAGE, MD

CONTACT

33-2-9928-5296emmanuelle.lepage@chu-rennes.fr

Veronique DEBURGHGRAEVE, MD

CONTACT

33-2-9928-89038veronique.deburghgraeve@chu-rennes.fr

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 24, 2009

First Posted

September 25, 2009

Study Start

March 1, 2008

Primary Completion

June 1, 2013

Study Completion

June 1, 2014

Last Updated

December 5, 2012

Record last verified: 2012-12

Locations

FR(14)