Table 2.
Summary of eptinezumab RCTs
| Study | Phase | Migraine/N | Study period | Primary outcome |
|---|---|---|---|---|
| NCT01772524 Dodick et al. (2014) [23] | II |
EM N = 174 |
3 months |
placebo: −4.6 1000 mg: − 5.6 (p = 0.03) |
| NCT02275117 Dodick et al. (2019) [24] | II |
CM N = 616 |
3 months |
≥ 75% migraine responder rate: placebo: 20.7% 10 mg: 33.3% (p = 0.033) 30 mg, 100 mg, 1000 mg (all NS) |
| NCT02559895 Ashina et al. (2020) (PROMISE-1) [25] | III |
EM N = 888 |
3 months |
placebo: −3.2 30 mg: − 4.0 (p = 0.0046) 100 mg: −3.9 (p = 0.0182) 300 mg: − 4.3 (p = 0.0001) |
|
NCT02974153 Lipton et al. (2020) (PROMISE-2) [26] |
III |
CM N = 1072 |
12 weeks |
placebo: −5.6 100 mg: −7.7 (p < 0.0001) 300 mg: −8.2 (p < 0.0001) |
| NCT04152083 Winner et al. (2021) (RELIEF) [27] | III |
CM N = 480 |
Acute treatment |
Time to pain freedom: placebo: 9 h 100 mg: 4 h (p < 0.001) Time to absence of MBS: placebo: 3 h 100 mg: 2 h (p < 0.001) |
All eptinezumab treatments were given intravenously. Primary outcome was MMD reduction for all studies except RELIEF and Dodick (2019) [24]
EM episodic migraine, CM chronic migraine, MMD mean monthly migraine day, NS non-significant