Multiple sclerosis MedDRA version: 15.0 Level: PT Classification code 10028245 Term: Multiple sclerosis System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Trade Name: Urbason 40 mg
Pharmaceutical Form: Capsule
CAS Number: 03/03/2375
Other descriptive name: METHYLPREDNISOLONE SODIUM HEMISUCCINATE
Concentration unit: mg milligram(s)
Concentration type: ra
Sponsors
Servicio de Neurología, HU. Germans Trias i Pujol
Eligibility
Sex/Gender
All
Inclusion criteria
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 (=65 years) no F.1.3.1 Number of subjects for this age range
Exclusion criteria
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 impairement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To assess the non-inferiority of clinical and radiological efficacy of the treatment with lower-high dose of oMP (625mg/day for 3 days) vs high dose of oMP (1250mg/day for 3 days) in patients in relapse of MS, 28 days after the treatment.;Secondary Objective: To assess the safety, tolerability and quality of life of both doses.;Primary end point(s): - To assess the non-inferiority in the improvement in relapse based on a margin of 1 on the EDSS disability scale of Kurtzke - and radiological: MRI improvement in the number of MRI lesions and gadolinium enhancement (Gd +);Timepoint(s) of evaluation of this end point: Baseline, day 8 and day 29 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): - Adverse events / tolerability - Questionnaires MSQOL-54 and MFIS;Timepoint(s) of evaluation of this end point: Baseline, day 8 and day 29 | — |
Countries
Spain
Contacts
Public ContactServicio de Neurología
Servicio de Neurología, HU. Germans Trias i Pujol
Outcome results
None listed