Study to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse.

Phase 1

• Conditions: Multiple sclerosis; MedDRA version: 15.0Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disorders; Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

• Registration Number: EUCTR2012-001965-34-ES
• Lead Sponsor: Servicio de Neurología, HU. Germans Trias i Pujol

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2012-08-09
• Last Update Posted: 17 May 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: Not specified

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.

Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 48
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

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

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 <br>- 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 Outcome Measures

Name	Time	Method
Secondary end point(s): - Adverse events / tolerability<br>- Questionnaires MSQOL-54 and MFIS;Timepoint(s) of evaluation of this end point: Baseline, day 8 and day 29