Multicenter, randomized, double-blind clinical trial to compare the clinical and radiological efficacy of 625 mg vs 1250 mg of oral methylprednisolone in patients with multiple sclerosis in relapse.

Servicio de Neurología, HU. Germans Trias i Pujol0 个研究点开始时间: 2012年8月9日最近更新: 2016年5月17日

适应症

试验速览

暂无简介。

•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

•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

发起方

Servicio de Neurología, HU. Germans Trias i Pujol