Disease Control and Safety in Patients With Relapsing Remitting Multiple Sclerosis (RRMS) Switching From Natalizumab to Fingolimod

• Status: Terminated
• Trial end date: 2012-11-01
• Target enrollment: 0
• Participant gender: All

Summary

This study evaluated disease control during different lengths of treatment transition from natalizumab to fingolimod.

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

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fingolimod Hydrochloride; Natalizumab

Criteria

Inclusion Criteria:

Patients must:

• Have relapsing remitting multiple sclerosis

• Have been on treatment with natalizumab for at least 6 months prior to screening and discontinuation is an option.

Exclusion Criteria:

Patients with:

• History of chronic immune disease

• Crohn's 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

• Resting heart rate less than 45 bpm.

• Certain heart conditions or certain lung conditions

• Inability to undergo MRI scans

Other protocol-defined inclusion/exclusion criteria may apply