CompletedPhase 4Relapsing MSNCT019869982012-001965-34

What it found

Result in a paper, not read yet

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

    Safety
  • Disability scale of Kurtzke EDSS score

    Baseline and day 8

    Disability progression
  • 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

    day -1 and day 29

    MRI lesions
  • Adverse events / tolerability

    Baseline and day 8

    Safety
  • Questionnaire 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

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Related trials

History

    1. Started

      Oct 2013

    2. Main results due

      Feb 2016

    3. Finished

      Mar 2016

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