- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00984984
Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses (COPOUSEP)
December 4, 2012 updated by: Rennes University Hospital
Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
200
Phase
- Phase 3
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Emmanuelle LE PAGE, MD
- Phone Number: 33-2-9928-5296
- Email: emmanuelle.lepage@chu-rennes.fr
Study Contact Backup
- Name: Veronique DEBURGHGRAEVE, MD
- Phone Number: 33-2-9928-89038
- Email: veronique.deburghgraeve@chu-rennes.fr
Study Locations
-
-
-
Brest, France, 29609
- Recruiting
- CHU Cavale Blanche
-
Contact:
- Rouhart
- Email: francois.rouhart@chu-brest.fr
-
Brest, France, 29249
- Recruiting
- Hôpital des Armées
-
Contact:
- zagnoli
- Email: fabien.zagnoli@wanaddo.fr
-
La Roche sur Yon, France, 85000
- Recruiting
- Centre Hospitalier de Vendée
-
Contact:
- de marco
- Email: olivier.demarco@chd-vendee.fr
-
Lannion, France, 22300
- Recruiting
- Centre Hospitalier de Lannion
-
Contact:
- Massengo
- Email: serge.massengo@wanadoo.fr
-
Lorient, France, 56100
- Recruiting
- Centre Hospitalier Bretagne Sud
-
Contact:
- Sartori
- Email: e.sartori@ch-bretagne-sud.fr
-
Nantes, France, 44000
- Recruiting
- CHU Laennec
-
Contact:
- Laplaud
- Email: david.laplaud@chu-nantes.fr
-
Contact:
- Wiertlewski
- Email: sandrine.wiertlewski@chu-nantes.fr
-
Paris, France, 75651 cedex 13
- Recruiting
- Hôpital La Pitié Salpêtrière
-
Contact:
- Papeix
- Phone Number: 33 1 42 16 17 51
-
Pontivy, France, 56300
- Recruiting
- Centre Hospitalier De Pontivy
-
Contact:
- Anani
- Email: thierry.anani@ch-pontivy.fr
-
Quimper, France, 29000
- Recruiting
- CH de Cornouaille
-
Contact:
- Coustans
- Email: m.coustans@ch-cornouaille.fr
-
Quimper, France, 29000
- Recruiting
- Hopital de Cornouaille
-
Contact:
- Coustans
- Email: m.coustans@ch-cornouaille.fr
-
Rennes, France, 35033
- Recruiting
- Rennes University Hospital
-
Contact:
- Le Page
- Email: emmanuelle.lepage@chu-rennes.fr
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Saint Brieuc, France, 22023
- Recruiting
- Hôpital Yves Le Foll
-
Contact:
- Lallement
- Email: francois.lallement@ch-stbrieuc.fr
-
Saint Malo, France, 35400
- Recruiting
- CH Saint Malo
-
Contact:
- taurin
- Email: g.taurin@ch-stmalo.fr
-
Vannes, France, 56000
- Recruiting
- Centre Hospitalier Bretagne Atlantique
-
Contact:
- Kassiotis
- Email: philippe.kassiotis@ch-bretagne-atlantique.fr
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 55 years (ADULT)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: TREATMENT
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: methylprednisolone 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
|
ACTIVE_COMPARATOR: methylprednisolone 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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
At least 1 point-reduction on Kurtzke functional scale
Time Frame: 28 days after beginning of corticotherapy
|
28 days after beginning of corticotherapy
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Emmanuelle Le Page, MD, Rennes University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2008
Primary Completion (ANTICIPATED)
June 1, 2013
Study Completion (ANTICIPATED)
June 1, 2014
Study Registration Dates
First Submitted
September 24, 2009
First Submitted That Met QC Criteria
September 24, 2009
First Posted (ESTIMATE)
September 25, 2009
Study Record Updates
Last Update Posted (ESTIMATE)
December 5, 2012
Last Update Submitted That Met QC Criteria
December 4, 2012
Last Verified
December 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Nervous System Diseases
- Immune System Diseases
- Demyelinating Autoimmune Diseases, CNS
- Autoimmune Diseases of the Nervous System
- Demyelinating Diseases
- Autoimmune Diseases
- Multiple Sclerosis
- Sclerosis
- Multiple Sclerosis, Relapsing-Remitting
- Physiological Effects of Drugs
- Autonomic Agents
- Peripheral Nervous System Agents
- Anti-Inflammatory Agents
- Antineoplastic Agents
- Antiemetics
- Gastrointestinal Agents
- Glucocorticoids
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Hormonal
- Neuroprotective Agents
- Protective Agents
- Prednisolone
- Methylprednisolone Acetate
- Methylprednisolone
- Methylprednisolone Hemisuccinate
- Prednisolone acetate
- Prednisolone hemisuccinate
- Prednisolone phosphate
Other Study ID Numbers
- 2007-000590-37
- ESP/07-09
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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