Study to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse
Condition: Multiple Sclerosis
MeSH terms: Multiple Sclerosis; Sclerosis; Recurrence
Study type: Interventional
Phase: Phase 4

Summary: 
      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.
    

Detailed description: 
      DESIGN: Phase IV clinical trial, multicentre, randomized and double blind, active drug
      controlled and parallel groups. Patients will be randomised to a high dose of oMP vs a
      lower-high dose of oral Methylprednisolone (oMP).

      SETTING: 9 MS Units from 9 hospitals of the public health system with extensive experience in
      treating patients with MS and design and participation in clinical trials.

      PROCEDURES:

      After signing the informed consent, the inclusion and exclusion criteria specific to the
      study will be checked. The diagnostic test will take place prior to administration of study
      medication and will include medical history, neurological examination (EDSS measurement)
      taking of vital signs (blood pressure, heart rate and body temperature) and MRI. Concomitant
      medication will be checked. Patients will be instructed about the requirements during the
      study.

      The trial medication will be provided to the patient in the medical office (day 1 of the
      study), where the patient will remain until the intake. This action will be repeated the
      following 2 days. The latency period from the beginning of the relapse until the start of
      treatment will be registered. The questionnaires of tolerance will be completed.

      Day 1 will be defined as the first day on which first dose of oMP is administered.

      Once given the treatment under study, the adverse events reported spontaneously or after
      question will be collected.

      There will be follow-up visits at 7 and 28 days, and 3 months after initiation of treatment.
      At baseline, prior to drug administration, and on days 7 and 28 after initiation of
      treatment, a brain MRI with and without contrast will be performed. In case of adverse events
      or laboratory abnormalities, the patients could have an accessory follow-up visits until
      resolution.

      Randomization will be performed on the day of administration (day 1)

      The treatments are:

      Group A: Methylprednisolone 1250 mg / day orally for 3 days Group B: Methylprednisolone 625
      mg / day orally for 3 days
    

Intervention name(s): Methylprednisolone 1250 mg/24h x3 days; Oral Methylprednisolone 625 mg/24h x3 days
Intervention type(s): Drug; Drug
Intervention description(s): Oral Methylprednisolone 1.250 mg daily, over 1 hour and during 3 consecutive days. 13 capsules will be administered (12 capsules of 100 mg and 1 capsule of 50 mg); Oral Methylprednisolone 625 mg daily, over 1 hour and during 3 consecutive days. 13 capsules will be administered (6 capsules of 100 mg, 1 capsule of 25 mg and 6 capsules of placebo with the same appearance of capsules of 100 mg)
Other intervention name(s): Group A; Group B
Intervention MeSH terms: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment
Keywords: Multiple sclerosis relapse; oral methylprednisolone; EDSS; gadolinium