Study to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse
What it found
A paper reports the results; we have not read it yet. See Papers below.
What was tested
Treatment tested
- Methylprednisolone
Glucocorticoid receptor agonist
What it measured
Main measures
Disability scale of Kurtzke EDSS score
up to day 91
Disability progression- To assess the non-inferiority in the improvement in relapse based on a margin of 1 on the EDSS disability scale of Kurtzke
Disability progressionRelapses
Other measures (7)
Adverse events / tolerability
Baseline and day 29
SafetyDisability scale of Kurtzke EDSS score
Baseline and day 8
Disability progressionThe 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
day -1 and day 29
MRI lesionsAdverse events / tolerability
Baseline and day 8
SafetyQuestionnaire MSQOL-54
Baseline and day 8
Quality of life (reported by participants)Questionnaire MSQOL-54
Baseline and day 29
Quality of life (reported by participants)- Adverse events / tolerability
Safety
Who could take part
Relapsing MS · 18 to 59
Inclusion Criteria: 1. Relapsing-remitting MS (Mc Donald criteria 2010) regardless being under immunomodulatory treatment 2. EDSS (previous to relapse) between 0 and 5 3. 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 * 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 4. Recent clinical relapse onset (\<15 days) without fever 5. One month of clinical stability prior to relapse 6. Signed informed consent 7. Capacity to ingest the medication. Exclusion Criteria: 1. Doubts about the diagnosis of multiple sclerosis 2. First episode of inflammatory neurological disease 3. Secondary progressive MS or primary progressive MS 4. Symptoms with lasted less than 24 hours of evolution 5. Any degree of subjective or objective remission 6. Treatment with corticosteroids during the previous 30 days 7. Patients with immunosuppressive treatment (azathioprine, mitoxantrone, cyclophosphamide) or Natalizumab or Fingolimod 8. Pregnancy or breastfeeding women or women of childbearing potential not using contraceptive measures 9. Diseases with a contraindication of treatment with corticosteroids 10. History of serious adverse reaction or hypersensitivity to drugs related to study medication 11. Patients who could not be regular MRI, not collaborators or who requires anesthesia. 12. Lactose intolerance 13. Patients with allergies to contrast used in MRI 14. Patients with renal impairment
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Loading reviews and guidelines…
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History
Started
Oct 2013
Main results due
Feb 2016
Finished
Mar 2016
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