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Eligibility
for people ages 10 years to 17 years
Location
at San Francisco, California and other locations
Dates
study started
estimated completion:
Principal Investigator

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-1a Interferon-beta Fingolimod Hydrochloride

Eligibility

You can join if…

Open to people ages 10 years to 17 years

  • 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 in progress, not accepting new patients
    Los Angeles, California, 90027, USA

Details

Status
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
November 2016
I'm interested in this study!