Randomized, open-label study to evaluate patient-reported outcomes (PRO) with fingolimod after changing from prior disease-modifying therapy (DMT) for relapsing multiple sclerosis (MS): EPOC study rationale and design

The efficacy and safety profiles of fingolimod (FTY720) have been well characterized in phase 2 and 3 studies; however, limited data exist on PRO. The EPOC study is evaluating PRO and safety in relapsing–remitting MS patients who have received
6 months’ treatment with a single approved DMT and are randomized 3:1 to receive oncedaily fingolimod 0.5 mg with no washout or to continue standard DMT (interferon-b-1a, interferon-b-1b, or glatiramer acetate) for 6 months, followed by a 3-month openlabel extension, in which the DMT group can change to fingolimod with no washout. The primary endpoint is change in patient-reported treatment satisfaction using the global satisfaction subscale of the Treatment Satisfaction Questionnaire for Medication (TSQM). Secondary endpoints are safety/tolerability, changes in physician-reported Clinical Global Impression-Improvement, and changes in the following PRO.: Fatigue Severity Scale; Beck Depression Inventory-II; activities of daily living using the Multiple Sclerosis Activities Scale (PRIMUS-Activities); effectiveness, side effects, and convenience subscales of the TSQM; and the Short-Form 36 Health Survey-v2-acute. The study is enrolling at approximately 175 US centers.