Multiple Sclerosis, Relapsing-RemittingPhase 3COPOUSEPNCT00984984
Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis (MS) Relapses
A Phase 3 study testing methylprednisolone PO and methylprednisolone IV in people with Multiple Sclerosis, Relapsing-Remitting, run by Rennes University Hospital at 14 sites in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Multiple Sclerosis, Relapsing-Remitting
- What is being tested?
- methylprednisolone PO and methylprednisolone IV
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 200 participants
- Where
- 14 sitesFrance
- Study dates
- Mar 2008to Jun 2014
- Phase
- Phase 3
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 10Show fewer
- liver or kidney failure
- psychiatric symptoms not under control
- pregnancy
- hypersensibility to methylprednisolone
Trial locations and contacts
14 sites in 1 country.
14 sites in 1 country
France14 sites, 14 recruiting
- Recruiting
Hôpital des Armées
Brest, 29249
zagnoli, fabien.zagnoli@wanaddo.fr
- Recruiting
CHU Cavale Blanche
Brest, 29609
Rouhart, francois.rouhart@chu-brest.fr
- Recruiting
Centre Hospitalier de Vendée
La Roche-sur-Yon, 85000
de marco, olivier.demarco@chd-vendee.fr
- Recruiting
Centre Hospitalier de Lannion
Lannion, 22300
Massengo, serge.massengo@wanadoo.fr
- Recruiting
Centre hospitalier Bretagne Sud
Lorient, 56100
Sartori, e.sartori@ch-bretagne-sud.fr
- Recruiting
CHU Laennec
Nantes, 44000
Laplaud, david.laplaud@chu-nantes.fr
Wiertlewski, sandrine.wiertlewski@chu-nantes.fr
- Recruiting
Hôpital La pitié Salpétriere
Paris, 75651 cedex 13
Papeix, 33 1 42 16 17 51
- Recruiting
Centre Hospitalier de Pontivy
Pontivy, 56300
Anani, thierry.anani@ch-pontivy.fr
- Recruiting
CH de Cornouaille
Quimper, 29000
coustans, m.coustans@ch-cornouaille.fr
- Recruiting
Hôpital de Cornouaille
Quimper, 29000
Coustans, m.coustans@ch-cornouaille.fr
- Recruiting
Rennes University Hospital
Rennes, 35033
Le Page, emmanuelle.lepage@chu-rennes.fr
- Recruiting
Hopital Yves Le Foll
Saint-Brieuc, 22023
Lallement, francois.lallement@ch-stbrieuc.fr
- Recruiting
CH Saint Malo
St-Malo, 35400
taurin, g.taurin@ch-stmalo.fr
- Recruiting
Centre Hospitalier Bretagne Atlantique
Vannes, 56000
Kassiotis, philippe.kassiotis@ch-bretagne-atlantique.fr
About this study
Official title: 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.
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Being tested
- methylprednisolone PO, methylprednisolone IV
- Medical subject headings
- Multiple Sclerosis, Relapsing-Remitting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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 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
| Study group | Role | What they receive |
|---|---|---|
| methylprednisolone PO | Experimental | Not described Receives: Drug: methylprednisolone PO |
| methylprednisolone IV | Active comparator | Not described Receives: Drug: methylprednisolone IV |
What is being measured
The primary outcome is the main question the study is designed to answer.
At least 1 point-reduction on Kurtzke functional scale
Measured: 28 days after beginning of corticotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Sep 2009 (estimated)
- Study startMar 2008
- Primary completionJun 2013 (estimated)
- Study completionJun 2014 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Multiple Sclerosis, Relapsing-RemittingStudies of the same condition, open and under way.
- More trials run by Rennes University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rennes University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Emmanuelle Le Page, MD, Principal investigator, Rennes University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00984984
- Sponsor's protocol ID
- 2007-000590-37
- Other IDs
- ESP/07-09
- Acronym
- COPOUSEP
- Status last verified
- Dec 2012
- First submitted
- 24 Sep 2009
- Last updated
- 5 Dec 2012
- Results posted
- No
- Data monitoring committee
- Yes
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.
PubMed 26135706
Study at a glance
From the registry record, last updated by the sponsor on 5 Dec 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomised Double-blinded Trial Comparing Efficacy and Safety of Methylprednisolone Per os Versus IV for the Treatment of Multiple Sclerosis Relapses
- ClinicalTrials.gov ID
- NCT00984984
- Acronym / sponsor ID
- COPOUSEP / 2007-000590-37
- Conditions
- Multiple Sclerosis, Relapsing-Remitting
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Rennes University HospitalUniversity, hospital or other
- Study start
- Mar 2008
- Primary completion
- Jun 2013 (estimated)
- Study completion
- Jun 2014 (estimated)
- First posted
- 25 Sep 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| methylprednisolone PO | Experimental | Drug: methylprednisolone PO |
| methylprednisolone IV | Active comparator | Drug: methylprednisolone IV |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (10 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| methylprednisolone PO10 capsules Methylprednisolone 100 mg and 50 ml IV NaCl 0,9% (syringe pump 30 mn to 2 h, every day during 3 days | Drug | methylprednisolone PO |
| methylprednisolone IVIV 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 | Drug | methylprednisolone IV |
Primary outcome
At least 1 point-reduction on Kurtzke functional scale
Time frame: 28 days after beginning of corticotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Dec 2012.
- Derived from this study: PubMed 26135706Le 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.
Related trials for Multiple Sclerosis, Relapsing-Remitting
Active, not recruiting
Myrosinase Bioactivated Gglucoraphanin for the Treatment of Neurodegenerative Diseases (GRA-MYR-ND)
PARKINSON DISEASE (Disorder), Multiple Sclerosis (MS) - Relapsing-remitting
Recruiting
Wearable Focal Vibration Therapy on Upper Extremity Function of People With Multiple Sclerosis: A Pilot Study
Multiple Sclerosis (MS) - Relapsing-remitting, Upper Extremity Dysfunction
Not yet recruiting
Treatment of Memory Retrieval Impairments in MS With HDtDCS to the LIFG in a Placebo Controlled Trial
Multiple Sclerosis, Relapsing-remitting Multiple Sclerosis (RRMS)
Recruiting
Monthly Monitoring of Plasma NfL in Treated Relapsing-remitting Multiple Sclerosis to Detect Persistent Infraclinical Disease Activity
Multiple Sclerosis (MS) - Relapsing-remitting
Active, not recruitingPhase 4
Safety and Efficacy Study of Fingolimod in Taiwanese Adults (≥ 20years) With Relapsing Remitting Multiple Sclerosis
Multiple Sclerosis
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Emmanuelle Le Page, MD principal investigator
Rennes University Hospital
14 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing methylprednisolone PO and methylprednisolone IV in people with Multiple Sclerosis, Relapsing-Remitting, run by Rennes University Hospital at 14 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Dec 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 14 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Emmanuelle LE PAGE, MD (33-2-9928-5296, emmanuelle.lepage@chu-rennes.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
At least 1 point-reduction on Kurtzke functional scale (time frame: 28 days after beginning of corticotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00984984, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Dec 2012.