Safety and Efficacy of Fingolimod in MS Patients in China

Last updated: April 20, 2017
Sponsor: Novartis Pharmaceuticals
Overall Status: Trial Not Available

Phase

3

Condition

Multiple Sclerosis

Neurologic Disorders

Memory Loss

Treatment

N/A

Clinical Study ID

NCT01941004
CFTY720D2315
  • Ages 18-50
  • All Genders

Study Summary

To evaluate the safety and efficacy of fingolimod 0.5mg vs. placebo in MS patients in China

Eligibility Criteria

Inclusion

Inclusion Criteria:

-Patients must have relapsing remitting multiple sclerosis

Exclusion

Exclusion Criteria: Patients with:

  • History of chronic immune disease

  • Certain cancers

  • Uncontrolled diabetes

  • Certain eye disorders -Negative for varicella

  • zoster virus IgG antibodies

  • Certain hepatic conditions

  • Low white blood cell count

  • On certain immunosuppressive medications or heart medications

  • Certain heart conditions or certain lung conditions

  • Inability to undergo MRI scans -Diagnosis of Neuromyelitis optica.

  • Other protocol defined inclusion/exclusion criteria may apply

Study Design

Study Start date:
June 01, 2014
Estimated Completion Date:
May 31, 2017