NCT01534182

Evaluation of Patient Reported Outcomes in RRMS Patients Candidates for MS Therapy Change and Transitioned to Fingolimod 0.5 mg (EPOC)

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 298 (actual)
• Sponsor: Novartis Pharmaceuticals · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

A 6-month, Randomized, Active Comparator, Open-label, Multi-Center Study to Evaluate Patient Outcomes, Safety and Tolerability of (fingolimod) 0.5 mg/day in Patients with Relapsing Remitting Multiple Sclerosis who are candidates for MS therapy change from Previous Disease Modifying Therapy.

Conditions

• Relapsing Remitting Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	Fingolimod	0.5 mg orally once a day
DRUG	Interferon beta - 1a (IFN)	44 mcg subcutaneously three times a week
DRUG	Glatiramer acetate (GA)	20 mg subcutaneously once a day

Timeline

• Start date: 2012-01-01
• Primary completion: 2013-06-01
• Completion: 2013-06-01
• First posted: 2012-02-16
• Last updated: 2014-08-08
• Results posted: 2014-08-08

Locations

26 sites across 1 country: Russia