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 Sclerosis pediatric Sclerosis Interferons Interferon-beta Interferon beta-1a Fingolimod Hydrochloride Interferon beta-1a i.m. injections Fingolimod oral capsules Fingolimod

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 Francisco California 94143 United States
  • Novartis Investigative Site
    Los Angeles California 90027 United 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