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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 pedaitric patients with multiple sclerosis

Official Title

Two-year, Double-blind, Randomzied, Multicenter, Active-controlled Study to Evaluate Safety and Efficacy of Oral Fingolimod Versus Interferon Beta-1a i.m. in Pediatric Patients With Multiple Sclerosis

Keywords

Multiple Sclerosis pediatric Interferons Interferon-beta Interferon beta-1a Fingolimod Hydrochloride

Eligibility

You can join if…

Open to people ages 10–17

  • 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

You CAN'T join if...

  • 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 Other protocol-defined inclusion/exclusion criteria may apply

Locations

  • 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
ID
NCT01892722
Phase
Phase 3
Lead Scientist
Emmanuelle Waubant
Study Type
Interventional
Last Updated
August 1, 2017