NCT01317004

Patients With Relapse Remitting Multiple Sclerosis (RRMS): Candidates for MS Therapy Change

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 Remitting Multiple Sclerosis Who Are Candidates for MS Therapy Change From Previous Disease Modifying Therapy (EPOC)

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 61 (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 treatment satisfaction after 6 months of treatment with fingolimod 0.5mg/day vs. DMT standard of care, using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM-9).

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Fingolimod	0.5 mg/day oral capsule
DRUG	Standard MS DMT	Interferon beta 1a or interferon beta 1b or Glatiramer Acetate

Timeline

• Start date: 2011-05-01
• Primary completion: 2014-06-01
• Completion: 2014-06-01
• First posted: 2011-03-16
• Last updated: 2015-06-22
• Results posted: 2015-06-22

Locations

17 sites across 1 country: Italy