Multiple SclerosisPhase 4NCT00753792
Oral Corticotherapy in Megadoses to Treat Multiple Sclerosis During Relapse
A Phase 4 study testing methylprednisolone in people with Multiple Sclerosis, run by Germans Trias i Pujol Hospital at 7 sites in Spain.
Trial summary
This is a phase IV, multicenter, randomized, double blind clinical trial. The investigators will study 48 patients with remitting relapsing multiple sclerosis (MS) experiencing moderate or severe attack receiving immunomodulatory therapy or not. Patients will be randomly assigned to one of the two groups. 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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 49 participants
- Where
- 7 sitesSpain
- Study dates
- Nov 2008to Jan 2011
- 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
- To have been diagnosed MS Remittent Recurrent according to Mc Donald 20052 criteria.
- To have an EDSS between 0 and 5 before the relapse.
- The symptoms have begun after at least one month of previous stability.
- The symptoms have started maximum 15 days before the inclusion.
- The patient is capable of having an adequate communication with the investigator and to carry out with the clinical trial requisites.
- To be or not to be with allowed immunomodulatory therapy (IFN-B /AG).
- To be capable and to be willing to ingest the medication.
Who cannot join
- First inflammatory neurological episode (relapse).
- Multiple sclerosis secondary progressive or primary progressive.
- The symptoms have gone on for less than 24 hours.
- To be in treatment or have been treated with corticoids during the three months before.
- Patients in treatment with immunosuppressors (azathioprine, mitoxantrone, ciclofosfamide...)
- Pregnancy or breastfeeding or women in fertile age who don't use contraceptives measurements.
Show all 13Show fewer
- Illnesses with contraindication treatment with corticoids.
- Antecedents of serious adverse effects or hypersensitive to related study medication.
- Patients who wouldn´t be able to perform periodic RMN explorations, patients who are not collaborative or who need anesthesia.
- Patients with intolerance to lactose.
- Patients with allergy to contrast used in RMN.
- Patients with chronic kidney disease.
- Patients in treatment with natalizumab.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
Spain7 sites
Germans Trias i Pujol Hospital
Badalona, Barcelona, 08916
Hospital de Mataró
Barcelona, Barcelona, 08034
Hospital Vall d'Hebron
Barcelona, Barcelona, 08035
Hospital Clinic de Barcelona
Barcelona, Barcelona, 08036
Hospital de Figueres
Figueres, Girona, 17600
Hospital Dr. Trueta
Girona, Girona, 17007
Hospital Arnau de Vilanova
Lleida, Lleida, 25198
About this study
Official title: Multicenter, Randomized, Double Blind, Clinical Trial to Compare the Clinical and Radiological Efficacy of Equivalent Doses of Methylprednisolone Administered Orally or Intravenously in Patients With Multiple Sclerosis During Relapse
This is a phase IV, multicenter, randomized, double blind clinical trial. The investigators will study 48 patients with remitting relapsing multiple sclerosis (MS) experiencing moderate or severe attack receiving immunomodulatory therapy or not. Patients will be randomly assigned to one of the two groups.
Read the detailed description
This is a multicenter, randomized, double blind clinical trial to test whether oral methylprednisolone (MP) is not inferior to intravenous methylprednisolone for the treatment of multiple sclerosis (MS) relapse in terms of clinical and radiological efficacy.
Patients will be randomly assigned to one of the following two groups.
Group A: methylprednisolone 1.000 mg/day intravenous administered during three days + placebo of methylprednisolone orally administered
Group B: methylprednisolone 1.250 mg/day orally administered during three days + placebo of methylprednisolone intravenously administered.
Clinical visits will be conducted at 7, 28 and 90 days after treatment starting.
- Conditions
- Multiple Sclerosis
- Being tested
- methylprednisolone, Placebo
- Keywords
- multiple sclerosis, relapse, methylprednisolone
- Medical subject headings
- Multiple Sclerosis, Recurrence
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Also called Group A
methylprednisolone 1.000 mg/day intravenous administration during three days
Also called Group B
methylprednisolone 1.250 mg/day orally administered during three days
PlaceboDrug
Also called Group A, Group B
Placebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1)
| Study group | Role | What they receive |
|---|---|---|
| 1 | Active comparator | methylprednisolone 1.000 mg/day intravenous administration during three days + placebo of methylprednisolone orally administered Receives: Drug: methylprednisolone; Drug: Placebo |
| 2 | Experimental | methylprednisolone 1.250 mg/day orally administered during three days + placebo of methylprednisolone intravenous administered Receives: Drug: methylprednisolone; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the punctuation of diana functional system score corresponding to in relapse of optic neuritis, trunk's syndrome and myelitis
Measured: day 28
Change in EDSS in patients who present a relapse from different type or unknown topography
Measured: day 28
Secondary outcomes (2)
Change in the punctuation in each group
Measured: between days 7 and 0
Percentage of patients who improve, get worse and keep stable
Measured: days 7 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Sep 2008 (estimated)
- Study startNov 2008
- Primary completionNov 2010
- Study completionJan 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)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
- Investigators
- Cristina Ramo, MD, Principal investigator, Germans Trias i Pujol Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00753792
- Sponsor's protocol ID
- CORTEM
- Other IDs
- 2007-000888-15
- Status last verified
- Jun 2011
- First submitted
- 16 Sep 2008
- Last updated
- 2 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Ramo-Tello C, Tintore M, Rovira A, Ramio-Torrenta L, Brieva L, Saiz A, Cano A, Carmona O, Hervas JV, Grau-Lopez L. Baseline clinical status as a predictor of methylprednisolone response in multiple sclerosis relapses. Mult Scler. 2016 Jan;22(1):117-21. doi: 10.1177/1352458515590648. Epub 2015 Jun 25.
PubMed 26540732Grau-Lopez L, Teniente-Serra A, Tintore M, Rovira A, Ramio-Torrenta L, Brieva L, Saiz A, Cano A, Carmona O, Hervas JV, Martinez-Caceres EM, Ramo-Tello C. Similar biological effect of high-dose oral versus intravenous methylprednisolone in multiple sclerosis relapses. Mult Scler. 2015 Apr;21(5):646-50. doi: 10.1177/1352458514546786. Epub 2014 Aug 21.
PubMed 25145693Ramo-Tello C, Grau-Lopez L, Tintore M, Rovira A, Ramio i Torrenta L, Brieva L, Cano A, Carmona O, Saiz A, Torres F, Giner P, Nos C, Massuet A, Montalban X, Martinez-Caceres E, Costa J. A randomized clinical trial of oral versus intravenous methylprednisolone for relapse of MS. Mult Scler. 2014 May;20(6):717-25. doi: 10.1177/1352458513508835. Epub 2013 Oct 21.
PubMed 24144876
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2011. 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 Equivalent Doses of Methylprednisolone Administered Orally or Intravenously in Patients With Multiple Sclerosis During Relapse
- ClinicalTrials.gov ID
- NCT00753792
- Acronym / sponsor ID
- CORTEM
- Conditions
- Multiple Sclerosis
- Keywords
- multiple sclerosis, relapse, methylprednisolone
- 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
- Nov 2008
- Primary completion
- Nov 2010 (actual)
- Study completion
- Jan 2011 (actual)
- First posted
- 17 Sep 2008 (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.
This is a phase IV, multicenter, randomized, double blind clinical trial. The investigators will study 48 patients with remitting relapsing multiple sclerosis (MS) experiencing moderate or severe attack receiving immunomodulatory therapy or not. Patients will be randomly assigned to one of the two groups.
Detailed description
This is a multicenter, randomized, double blind clinical trial to test whether oral methylprednisolone (MP) is not inferior to intravenous methylprednisolone for the treatment of multiple sclerosis (MS) relapse in terms of clinical and radiological efficacy.
Patients will be randomly assigned to one of the following two groups.
Group A: methylprednisolone 1.000 mg/day intravenous administered during three days + placebo of methylprednisolone orally administered
Group B: methylprednisolone 1.250 mg/day orally administered during three days + placebo of methylprednisolone intravenously administered.
Clinical visits will be conducted at 7, 28 and 90 days after treatment starting.
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 |
|---|---|---|
| 1 | Active comparator | Drug: methylprednisolone, Drug: Placebomethylprednisolone 1.000 mg/day intravenous administration during three days + placebo of methylprednisolone orally administered |
| 2 | Experimental | Drug: methylprednisolone, Drug: Placebomethylprednisolone 1.250 mg/day orally administered during three days + placebo of methylprednisolone intravenous administered |
Who may qualify
- Ages
- 18 to 59 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- To have been diagnosed MS Remittent Recurrent according to Mc Donald 20052 criteria.
- To have an EDSS between 0 and 5 before the relapse.
- The symptoms have begun after at least one month of previous stability.
- The symptoms have started maximum 15 days before the inclusion.
- The patient is capable of having an adequate communication with the investigator and to carry out with the clinical trial requisites.
Key exclusion criteria (13 listed)
- First inflammatory neurological episode (relapse).
- Multiple sclerosis secondary progressive or primary progressive.
- The symptoms have gone on for less than 24 hours.
- To be in treatment or have been treated with corticoids during the three months before.
- Patients in treatment with immunosuppressors (azathioprine, mitoxantrone, ciclofosfamide...)
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 |
|---|---|---|
| methylprednisoloneAlso: Group Amethylprednisolone 1.000 mg/day intravenous administration during three days | Drug | 1 |
| methylprednisoloneAlso: Group Bmethylprednisolone 1.250 mg/day orally administered during three days | Drug | 2 |
| PlaceboAlso: Group A, Group BPlacebo of methylprednisolone administered intravenously (Arm 2) or orally (Arm 1) | Drug | 1, 2 |
Primary outcome
Change in the punctuation of diana functional system score corresponding to in relapse of optic neuritis, trunk's syndrome and myelitis
Time frame: day 28
Change in EDSS in patients who present a relapse from different type or unknown topography
Time frame: day 28
2 secondary outcomes
Change in the punctuation in each group
Time frame: between days 7 and 0
Percentage of patients who improve, get worse and keep stable
Time frame: days 7 and 28
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 2 Jun 2011.
- Derived from this study: PubMed 26540732Ramo-Tello C, Tintore M, Rovira A, Ramio-Torrenta L, Brieva L, Saiz A, Cano A, Carmona O, Hervas JV, Grau-Lopez L. Baseline clinical status as a predictor of methylprednisolone response in multiple sclerosis relapses. Mult Scler. 2016 Jan;22(1):117-21. doi: 10.1177/1352458515590648. Epub 2015 Jun 25.
- Derived from this study: PubMed 25145693Grau-Lopez L, Teniente-Serra A, Tintore M, Rovira A, Ramio-Torrenta L, Brieva L, Saiz A, Cano A, Carmona O, Hervas JV, Martinez-Caceres EM, Ramo-Tello C. Similar biological effect of high-dose oral versus intravenous methylprednisolone in multiple sclerosis relapses. Mult Scler. 2015 Apr;21(5):646-50. doi: 10.1177/1352458514546786. Epub 2014 Aug 21.
- Derived from this study: PubMed 24144876Ramo-Tello C, Grau-Lopez L, Tintore M, Rovira A, Ramio i Torrenta L, Brieva L, Cano A, Carmona O, Saiz A, Torres F, Giner P, Nos C, Massuet A, Montalban X, Martinez-Caceres E, Costa J. A randomized clinical trial of oral versus intravenous methylprednisolone for relapse of MS. Mult Scler. 2014 May;20(6):717-25. doi: 10.1177/1352458513508835. Epub 2013 Oct 21.
Related trials for Multiple Sclerosis
RecruitingPhase 2
Metformin as an add-on or Monotherapy in Treatment of Aging People With Multiple Sclerosis (MS)
Multiple Sclerosis
RecruitingObservational study
Pain Phenotypes in Individuals With Multiple Sclerosis
Multiple Sclerosis, Chronic Pain
Not yet recruiting
Evaluating the Effect of the Zeen Mobility Device on Clinical Practicality, Safety, and Impact (Via Assessments of Walking, Standing Tolerance, Balance, Endurance, Effort, and Participation in Daily Tasks) in an Outpatient Rehabilitation Setting for Individuals With Mobility Impairments.
Stroke, Parkinson's Disease (PD)
RecruitingPhase 3
Dalfampridine Combined With Physical Therapy for Mobility Impairment in Multiple Sclerosis
Multiple Sclerosis
RecruitingPhase 2
Targeting Agonists of Glucagon-like Peptide-1 Receptor for 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.
Cristina Ramo, MD principal investigator
Germans Trias i Pujol Hospital
7 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 in people with Multiple Sclerosis, run by Germans Trias i Pujol Hospital at 7 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 7 inclusion and 13 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 2 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 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?
Change in the punctuation of diana functional system score corresponding to in relapse of optic neuritis, trunk's syndrome and myelitis (time frame: day 28). The study lists 2 primary outcomes in all. 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 NCT00753792, which also lists 3 linked publications.
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 2 Jun 2011.