Safety and Efficacy of Fingolimod in MS Patients in China

• Status: Withdrawn
• Trial end date: 2017-05-01
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fingolimod Hydrochloride

Criteria

Inclusion Criteria:

-Patients must have relapsing remitting multiple sclerosis

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