NCT01216072

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

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient OutComes, Safety and Tolerability of Fingolimod (FTY720) 0.5 mg/Day in Patients With Relapsing Forms of Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 1,053 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Relapsing Forms of Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Fingolimod	0.5 mg/day oral capsule
DRUG	Standard MS DMTs

Timeline

• Start date: 2010-08-01
• Primary completion: 2012-08-01
• Completion: 2012-08-01
• First posted: 2010-10-07
• Last updated: 2014-02-10
• Results posted: 2013-12-05

Locations

149 sites across 3 countries: United States, Canada, Puerto Rico