Return to Results

24-month Double-blind, Randomized, Multicenter, Placebo-controlled, Parallel-group Study Comparing the Efficacy and Safety of 0.5 mg and 1.25 mg Fingolimod (FTY720) Administered Orally Once Daily Vers

new search

Trial Conditions
  • Multiple Sclerosis
What is the purpose of this trial?

This study assessed the safety, tolerability and efficacy of two doses of oral fingolimod compared to placebo on efficacy parameters in patients with relapsing-remitting multiple sclerosis (RRMS).

Date & Status


Who can Participate?


18  - 55 



Inclusion Criteria:

- Male and female patients between ages 18-55 with a diagnosis of multiple sclerosis

- Patients with a relapsing-remitting disease course

- Patients with expanded disability status scale (EDSS) score of 0-5.5

Exclusion Criteria:

- Patients with other chronic disease of the immune system, malignancies, acute
pulmonary disease, cardiac failure, etc.

- Pregnant or nursing women

For inclusion in the extension phase patients should complete the 24 month core study with
or without 24 months on study drug. If a patient discontinued study drug during the core
study due to an adverse event, serious adverse event, laboratory abnormality etc. they
would be excluded from the Extension Phase.

Other protocol-defined inclusion/exclusion criteria may apply.

Gender: Both
Steward Physician(s)
  • Novartis Pharmaceuticals
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
  • Fingolimod
  • Placebo
Physician Researcher

Investigator Name:

  • Novartis Pharmaceuticals

Other Information

Sponsor: Novartis
Phase: Phase 3
Trial ID: NCT00355134
Volunteers:  Not Accepting Healthy Volunteers

new search

Connect with Steward

Visit Our Twitter Feed Visit Our Facebook Page Email This Page Print This Page

Subscribe to our patient e-newsletter

Copyright © 2015 Steward Health Care
Connect Healthcare Panacea CMS Solutions