A 6-month, Randomized, Open-label, Patient OutComes, Safety and Tolerability Study of Fingolimod (FTY720) 0.5 mg/Day vs. Comparator in Patients With Relapsing Forms of Multiple Sclerosis

• Status: Completed
• Trial end date: 2012-08-01
• Target enrollment: 0
• Participant gender: All

Summary

The purpose of this study is to evaluate the change in patient-reported outcomes, physician assessment of a change as well as safety and tolerability in patients with Relapsing Forms of Multiple Sclerosis on previous Disease Modifying Therapy (DMT) who are randomized to one of two treatment arms: fingolimod vs. standard of care DMT.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Novartis Pharmaceuticals
• Treatments: Fingolimod Hydrochloride; Interferon beta-1b

Criteria

Inclusion Criteria:

• Relapsing forms of MS

• Expanded Disability Status Scale (EDSS) 0-5.5

• Continuous treatment with MS DMT for a minimum of 6 months

• Fingolimod naive

Exclusion Criteria:

• Immune system diseases other than MS

• Active macular edema

• History of selected prior infections and criteria for immunizations

• History of selected immune system treatments and/or medications

• Selected cardiovascular, pulmonary, or hepatic conditions

• Selected abnormal laboratory values

• Pregnant or nursing women

Other protocol-defined inclusion/exclusion criteria applied