Study to Compare the Clinical and Radiological Efficacy of 625 mg Versus 1250 mg of Oral Methylprednisolone in Patients With Multiple Sclerosis in Relapse

• Status: Completed
• Trial end date: 2016-03-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Germans Trias i Pujol Hospital
• Treatments: Methylprednisolone; Methylprednisolone Acetate; Methylprednisolone Hemisuccinate; Prednisolone; Prednisolone acetate; Prednisolone hemisuccinate; Prednisolone phosphate

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 (<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