Multiple SclerosisPhase 4NCT01986998
Study to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse
A Phase 4 study testing Methylprednisolone 1250 mg/24h x3 days and Oral Methylprednisolone 625 mg/24h x3 days in people with Multiple Sclerosis, run by Germans Trias i Pujol Hospital at 8 sites in Spain.
Trial summary
The investigators plan to carry out a multicenter randomized clinical trial and MRI study of high-dose oMP (1250mg/day for 3 days) versus lower-high dose oMP (625mg/day for 3 days) and demonstrated that lower-high dose of oMP is as effective as a higher-high dose of oMP in acute relapse of multiple sclerosis (MS). Read more about this study
- Who is it for?
- Ages 18 to 59 years
- Conditions the study is for
- Multiple Sclerosis
- What is being tested?
- Methylprednisolone 1250 mg/24h x3 days and Oral Methylprednisolone 625 mg/24h x3 days
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 49 participants
- Where
- 8 sitesSpain
- Study dates
- Oct 2013to Mar 2016
- Phase
- Phase 4
- 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 59 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Relapsing-remitting MS (Mc Donald criteria 2010) regardless being under immunomodulatory treatment
- EDSS (previous to relapse) between 0 and 5
- MS relapse of moderate intensity (EDSS increase from 1 to 2.5 points) or severe intensity (EDSS increase > 3 points)
- If EDSS previous relapse is available:
- optic neuritis, myelitis or brainstem relapse: the EDSS should increase of 1 point in visual, pyramidal or brainstem system function
- relapse in other location or uncertain location: the EDSS should increase at least 1 point
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- If EDSS previous relapse is not available:
- optic neuritis, myelitis or brainstem relapse: the visual, pyramidal or brainstem system function should be > 2 points.
- relapse in other location or uncertain location: EDSS should be > 2 points
- Recent clinical relapse onset (<15 days) without fever
- One month of clinical stability prior to relapse
- Signed informed consent
- Capacity to ingest the medication.
Who cannot join
- Doubts about the diagnosis of multiple sclerosis
- First episode of inflammatory neurological disease
- Secondary progressive MS or primary progressive MS
- Symptoms with lasted less than 24 hours of evolution
- Any degree of subjective or objective remission
- Treatment with corticosteroids during the previous 30 days
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- Patients with immunosuppressive treatment (azathioprine, mitoxantrone, cyclophosphamide) or Natalizumab or Fingolimod
- Pregnancy or breastfeeding women or women of childbearing potential not using contraceptive measures
- Diseases with a contraindication of treatment with corticosteroids
- History of serious adverse reaction or hypersensitivity to drugs related to study medication
- Patients who could not be regular MRI, not collaborators or who requires anesthesia.
- Lactose intolerance
- Patients with allergies to contrast used in MRI
- Patients with renal impairment
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Spain8 sites
Hospital Universitari Germans Trias I Pujol de
Badalona, Barcelona, 08916
Hospital Del Mar
Barcelona, Barcelona, 08003
Hospital de Mataró
Barcelona, Barcelona, 08034
Hospital Clinic I Provincial de Barcelona
Barcelona, Barcelona, 08036
Hospital de Sant Joan Despí Moisés Broggi
Barcelona, Barcelona
Hospital Universitari de Girona Dr. Josep Trueta
Girona, Girona, 17007
Hospital Universitari Arnau de Vilanova de Lleida
Lleida, Lleida, 25198
Hospital de Sant Pau I Santa Tecla
Tarragona, Tarragona
About this study
Official title: Multicenter, Randomized, Double-blind Clinical Trial to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse.
The investigators plan to carry out a multicenter randomized clinical trial and MRI study of high-dose oMP (1250mg/day for 3 days) versus lower-high dose oMP (625mg/day for 3 days) and demonstrated that lower-high dose of oMP is as effective as a higher-high dose of oMP in acute relapse of multiple sclerosis (MS). If it is shown, our purpose is to promote this therapeutic regimen because it is safer for the patient (less adverse effects) and less costly to the healthcare system.
Read the detailed description
DESIGN: Phase IV clinical trial, multicentre, randomized and double blind, active drug controlled and parallel groups. Patients will be randomised to a high dose of oMP vs a lower-high dose of oral Methylprednisolone (oMP).
SETTING: 9 MS Units from 9 hospitals of the public health system with extensive experience in treating patients with MS and design and participation in clinical trials.
PROCEDURES:
After signing the informed consent, the inclusion and exclusion criteria specific to the study will be checked. The diagnostic test will take place prior to administration of study medication and will include medical history, neurological examination (EDSS measurement) taking of vital signs (blood pressure, heart rate and body temperature) and MRI. Concomitant medication will be checked. Patients will be instructed about the requirements during the study.
The trial medication will be provided to the patient in the medical office (day 1 of the study), where the patient will remain until the intake. This action will be repeated the following 2 days. The latency period from the beginning of the relapse until the start of treatment will be registered. The questionnaires of tolerance will be completed.
Day 1 will be defined as the first day on which first dose of oMP is administered.
Once given the treatment under study, the adverse events reported spontaneously or after question will be collected.
There will be follow-up visits at 7 and 28 days, and 3 months after initiation of treatment. At baseline, prior to drug administration, and on days 7 and 28 after initiation of treatment, a brain MRI with and without contrast will be performed. In case of adverse events or laboratory abnormalities, the patients could have an accessory follow-up visits until resolution.
Randomization will be performed on the day of administration (day 1)
The treatments are:
Group A: Methylprednisolone 1250 mg / day orally for 3 days Group B: Methylprednisolone 625 mg / day orally for 3 days
- Conditions
- Multiple Sclerosis
- Being tested
- Methylprednisolone 1250 mg/24h x3 days, Oral Methylprednisolone 625 mg/24h x3 days
- Keywords
- Multiple sclerosis relapse, oral methylprednisolone, EDSS, gadolinium
- Medical subject headings
- Multiple Sclerosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone 1250 mg/24h x3 daysDrug
Also called Group A
Oral Methylprednisolone 1.250 mg daily, over 1 hour and during 3 consecutive days. 13 capsules will be administered (12 capsules of 100 mg and 1 capsule of 50 mg)
Oral Methylprednisolone 625 mg/24h x3 daysDrug
Also called Group B
Oral Methylprednisolone 625 mg daily, over 1 hour and during 3 consecutive days. 13 capsules will be administered (6 capsules of 100 mg, 1 capsule of 25 mg and 6 capsules of placebo with the same appearance of capsules of 100 mg)
| Study group | Role | What they receive |
|---|---|---|
| oMP 1250 mg: Group A | Active comparator | Methylprednisolone 1250 mg/24h x3 days Receives: Drug: Methylprednisolone 1250 mg/24h x3 days |
| oMP 625 mg: Group B | Active comparator | Methylprednisolone oral 625 mg/24h x3 days Receives: Drug: Oral Methylprednisolone 625 mg/24h x3 days |
What is being measured
The primary outcome is the main question the study is designed to answer.
Disability scale of Kurtzke EDSS score
Measured: up to day 91
Secondary outcomes (6)
Adverse events / tolerability
Measured: Baseline and day 29
Disability scale of Kurtzke EDSS score
Measured: Baseline and day 8
The number and volume of active lesions (measured by the T2 or gadolinium enhancement), the number of new active lesions and the percentage of active lesions at baseline that becomes black holes
Measured: day -1 and day 29
Adverse events / tolerability
Measured: Baseline and day 8
Questionnaire MSQOL-54
Measured: Baseline and day 8
Questionnaire MSQOL-54
Measured: Baseline and day 29
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2013 (estimated)
- Study startOct 2013
- Primary completionFeb 2016
- Study completionMar 2016
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 SclerosisStudies of the same condition, open and under way.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 49 participants (actual)
Sponsor and investigators
- Lead sponsor
- Germans Trias i Pujol Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Cristina Ramo, Germans Trias i Pujol Hospital
- Investigators
- Cristina Ramo, MD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01986998
- Sponsor's protocol ID
- oral-CORTEM
- Other IDs
- 2012-001965-34
- Status last verified
- Jun 2016
- First submitted
- 11 Jan 2013
- Last updated
- 3 Jun 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Hervas-Garcia JV, Ramio-Torrenta L, Brieva-Ruiz L, Batlle-Nadal J, Moral E, Blanco Y, Cano-Orgaz A, Presas-Rodriguez S, Torres F, Capellades J, Ramo-Tello C. Comparison of two high doses of oral methylprednisolone for multiple sclerosis relapses: a pilot, multicentre, randomized, double-blind, non-inferiority trial. Eur J Neurol. 2019 Mar;26(3):525-532. doi: 10.1111/ene.13851. Epub 2018 Nov 16.
PubMed 30351511
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Randomized, Double-blind Clinical Trial to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse.
- ClinicalTrials.gov ID
- NCT01986998
- Acronym / sponsor ID
- oral-CORTEM
- Conditions
- Multiple Sclerosis
- Keywords
- Multiple sclerosis relapse, oral methylprednisolone, EDSS, gadolinium
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 49 participants (actual)
- Lead sponsor
- Germans Trias i Pujol HospitalUniversity, hospital or other
- Study start
- Oct 2013
- Primary completion
- Feb 2016 (actual)
- Study completion
- Mar 2016 (actual)
- First posted
- 19 Nov 2013 (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 investigators plan to carry out a multicenter randomized clinical trial and MRI study of high-dose oMP (1250mg/day for 3 days) versus lower-high dose oMP (625mg/day for 3 days) and demonstrated that lower-high dose of oMP is as effective as a higher-high dose of oMP in acute relapse of multiple sclerosis (MS). If it is shown, our purpose is to promote this therapeutic regimen because it is safer for the patient (less adverse effects) and less costly to the healthcare system.
Detailed description
DESIGN: Phase IV clinical trial, multicentre, randomized and double blind, active drug controlled and parallel groups. Patients will be randomised to a high dose of oMP vs a lower-high dose of oral Methylprednisolone (oMP).
SETTING: 9 MS Units from 9 hospitals of the public health system with extensive experience in treating patients with MS and design and participation in clinical trials.
PROCEDURES:
After signing the informed consent, the inclusion and exclusion criteria specific to the study will be checked. The diagnostic test will take place prior to administration of study medication and will include medical history, neurological examination (EDSS measurement) taking of vital signs (blood pressure, heart rate and body temperature) and MRI. Concomitant medication will be checked. Patients will be instructed about the requirements during the study.
The trial medication will be provided to the patient in the medical office (day 1 of the study), where the patient will remain until the intake. This action will be repeated the following 2 days. The latency period from the beginning of the relapse until the start of treatment will be registered. The questionnaires of tolerance will be completed.
Day 1 will be defined as the first day on which first dose of oMP is administered.
Once given the treatment under study, the adverse events reported spontaneously or after question will be collected.
There will be follow-up visits at 7 and 28 days, and 3 months after initiation of treatment. At baseline, prior to drug administration, and on days 7 and 28 after initiation of treatment, a brain MRI with and without contrast will be performed. In case of adverse events or laboratory abnormalities, the patients could have an accessory follow-up visits until resolution.
Randomization will be performed on the day of administration (day 1)
The treatments are:
Group A: Methylprednisolone 1250 mg / day orally for 3 days Group B: Methylprednisolone 625 mg / day orally for 3 days
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oMP 1250 mg: Group A | Active comparator | Drug: Methylprednisolone 1250 mg/24h x3 daysMethylprednisolone 1250 mg/24h x3 days |
| oMP 625 mg: Group B | Active comparator | Drug: Oral Methylprednisolone 625 mg/24h x3 daysMethylprednisolone oral 625 mg/24h x3 days |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Relapsing-remitting MS (Mc Donald criteria 2010) regardless being under immunomodulatory treatment
- EDSS (previous to relapse) between 0 and 5
- MS relapse of moderate intensity (EDSS increase from 1 to 2.5 points) or severe intensity (EDSS increase > 3 points)
- Recent clinical relapse onset (<15 days) without fever
- One month of clinical stability prior to relapse
Key exclusion criteria (14 listed)
- Doubts about the diagnosis of multiple sclerosis
- First episode of inflammatory neurological disease
- Secondary progressive MS or primary progressive MS
- Symptoms with lasted less than 24 hours of evolution
- Any degree of subjective or objective remission
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 1250 mg/24h x3 daysAlso: Group AOral Methylprednisolone 1.250 mg daily, over 1 hour and during 3 consecutive days. 13 capsules will be administered (12 capsules of 100 mg and 1 capsule of 50 mg) | Drug | oMP 1250 mg: Group A |
| Oral Methylprednisolone 625 mg/24h x3 daysAlso: Group BOral Methylprednisolone 625 mg daily, over 1 hour and during 3 consecutive days. 13 capsules will be administered (6 capsules of 100 mg, 1 capsule of 25 mg and 6 capsules of placebo with the same appearance of capsules of 100 mg) | Drug | oMP 625 mg: Group B |
Primary outcome
Disability scale of Kurtzke EDSS score
Time frame: up to day 91
6 secondary outcomes
Adverse events / tolerability
Time frame: Baseline and day 29
Disability scale of Kurtzke EDSS score
Time frame: Baseline and day 8
The number and volume of active lesions (measured by the T2 or gadolinium enhancement), the number of new active lesions and the percentage of active lesions at baseline that becomes black holes
Time frame: day -1 and day 29
Adverse events / tolerability
Time frame: Baseline and day 8
Questionnaire MSQOL-54
Time frame: Baseline and day 8
Questionnaire MSQOL-54
Time frame: Baseline and day 29
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2016.
- Derived from this study: PubMed 30351511Hervas-Garcia JV, Ramio-Torrenta L, Brieva-Ruiz L, Batlle-Nadal J, Moral E, Blanco Y, Cano-Orgaz A, Presas-Rodriguez S, Torres F, Capellades J, Ramo-Tello C. Comparison of two high doses of oral methylprednisolone for multiple sclerosis relapses: a pilot, multicentre, randomized, double-blind, non-inferiority trial. Eur J Neurol. 2019 Mar;26(3):525-532. doi: 10.1111/ene.13851. Epub 2018 Nov 16.
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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.
Cristina Ramo, MD principal investigator
Germans Trias i Pujol Hospital
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Methylprednisolone 1250 mg/24h x3 days and Oral Methylprednisolone 625 mg/24h x3 days in people with Multiple Sclerosis, run by Germans Trias i Pujol Hospital at 8 sites in Spain.
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 13 inclusion and 14 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: finished, as of the sponsor's last update on 3 Jun 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites in Spain. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Disability scale of Kurtzke EDSS score (time frame: up to day 91). 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 NCT01986998, 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 3 Jun 2016.