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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

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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

Completed

Who can Participate?

Eligibility

Ages:
18  - 55 

Gender:
Both

Eligibility

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
Facilities
  • St. Elizabeth's Medical Center - Completed
Trial Interventions
Drug
  • Fingolimod
  • Placebo
Physician Researcher

Investigator Name:

  • Novartis Pharmaceuticals

Other Information

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

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