Summary

for people ages 10-17 (full criteria)
at San Francisco, California and other locations
study started
estimated completion

Description

Summary

To evaluate the safety and efficacy of fingolimod vs. interferon beta-1a i.m. in pediatric patients with multiple sclerosis

Official Title

A 2 Year, Double-blind, Randomized, Multicenter, Active-controlled Core Phase to Evaluate Safety & Efficacy of Daily Fingolimod vs Weekly Interferon β-1a im in Pediatric Patients With Multiple Sclerosis and 5 Year Fingolimod Extension Phase

Keywords

Multiple SclerosispediatricSclerosisInterferonsInterferon-betaInterferon beta-1aFingolimod HydrochlorideInterferon beta-1a i.m. injectionsFingolimod oral capsulesFingolimod

Eligibility

For people ages 10-17

Key Inclusion Criteria:

  • diagnosis of multiple sclerosis
  • at least one MS relapse during the previous year or two MS relapses in the previous 2 years or evidence of Gd enhancing lesions on MRI within 6 months EDSS score of 0 to 5.5, inclusive

Key Exclusion Criteria:

  • patients with progressive MS
  • patients with an active, chronic disease of the immune system other than MS
  • patients meeting the definition of ADEM
  • patients with severe cardiac disease or significant findings on the screening ECG.
  • patients with severe renal insufficiency

Locations

  • Novartis Investigative Site
    San FranciscoCalifornia94143United States
  • Novartis Investigative Site
    Los AngelesCalifornia90027United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Novartis Pharmaceuticals
Links
Recruitment website
ID
NCT01892722
Phase
Phase 3
Study Type
Interventional
Last Updated