Table 3.

Summary of other clinical trials

Study	Study design	Treatment armsx	Primary end point	Results
FREEDOMS II43	Phase II, 6-month, double-blind, parallel-group, placebo-controlled, multicenter	Fingolimod 0.5 mg orally, daily Fingolimod 1.25 mg orally, daily Placebo	Total number of Gd+ lesions on T1-w MRI at month 6	Free from Gd+ lesions: 82%
FIRST34	Phase IIIb, 4-month, open-label, single-arm, multicenter	Fingolimod 0.5 mg orally, daily ×16 weeks	Evaluate the short-term safety and tolerability profile of fingolimod 0.5 mg with focus on cardiac safety	Cardiac effects following FDO are transient, mostly asymptomatic, and observed in the first 6 hours post-dose Suggest no increased risk of symptomatic or serious cardiac events during treatment initiation in patients with preexisting cardiac conditions or in those receiving beta blockers or calcium-channel blockers
CFTY72045 DIT0340	Non-comparative, open-label, multicenter (Italy)	Fingolimod 0.5 mg orally on FDO	Evaluate the safety and tolerability data associated with initial dose of Fingolimod	Safety and tolerability in “real-world” setting was similar to what was seen in pivotal trials
EPOC46,71	6-month, randomized, active comparator, open-label, multicenter	Fingolimod 0.5 mg orally, daily IFNβ-1a 44 μg subcutaneous, 3 times a week GA 20 mg, subcutaneous, daily	Evaluate the safety and tolerability and patient outcomes who are changing from previous disease-modifying therapy to fingolimod	Safety and tolerability similar to what was seen in pivotal trials

Abbreviations: Gd+, gadolinium-enhanced; T1-w, T1-weighted; MRI, magnetic resonance imaging; FDO, first-dose observation; IFNβ-1a, interferon beta-1a; GA, glatiramer acetate.