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Clinical Trials/EUCTR2012-001965-34-ES
EUCTR2012-001965-34-ES
Active, not recruiting
Phase 1

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 sitesAugust 9, 2012
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ConditionsMultiple sclerosisMedDRA version: 15.0Level: PTClassification code 10028245Term: Multiple sclerosisSystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
DrugsUrbason 40 mg

Overview

Phase
Phase 1
Intervention
Not specified
Conditions
Multiple sclerosis
Sponsor
Servicio de Neurología, HU. Germans Trias i Pujol
Status
Active, not recruiting
Last Updated
9 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
August 9, 2012
End Date
TBD
Last Updated
9 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
All

Investigators

Sponsor
Servicio de Neurología, HU. Germans Trias i Pujol

Eligibility 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

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

Outcomes

Primary Outcomes

Not specified

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