Table 5.
Study | Phase | Migraine | Study period/N | Primary outcome |
---|---|---|---|---|
NCT01952574 Sun et al. (2016) [42] | II |
EM N = 483 |
3 months |
placebo: −2.3 70 mg: −3.4 (p = 0.021) 7 mg and 21 mg (NS) |
NCT02066415 Tepper et al. (2017) [43] | II |
CM N = 667 |
3 months |
placebo: −4.2 70 mg: − 6.6 (p < 0.0001) 140 mg: −6.6 (p < 0.0001) |
NCT02630459 Sakai et al. (2019) [44] | II |
EM N = 475 |
4–6 months |
placebo: 0.06 28 mg: −1.19 (p = 0.004) 70 mg: −2.25 (p < 0.001) 140 mg: −1.83 (p < 0.001) |
NCT02456740 Goadsby et al. (2017) (STRIVE) [45] | III |
EM N = 955 |
4–6 months |
placebo: −1.8 70 mg: −3.2 (p < 0.001) 140 mg: −3.7 (p < 0.001) |
NCT02483585 Dodick et al. (2018) (ARISE) [46] | III |
EM N = 577 |
3 months |
placebo: −1.8 70 mg: −2.9 (p < 0.001) |
NCT03096834 Reuter et al. (2018) (LIBERTY) [49] | III |
EM N = 246 |
3 months |
50% responder rate placebo: 14% 140 mg: 30% (p = 0.002) |
NCT03812224 Takeshima et al. (2021) [47] | III |
EM, CM N = 261 |
4–6 months |
placebo: −1.98 70 mg: −3.60 (p < .001) |
NCT03333109 Wang et al. (2021) EMPOwER [48] | III |
EM N = 900 |
3 months |
placebo: −3.1 70 mg: −4.2 (p = 0.002) 140 mg: −4.8 (p < 0.001) |
All studies required ≤ 2 classes of failed preventive treatments except, Tepper et al. (≤ 3 classes), LIBERTY (2–4 classes), and Takeshima et al. (≤ 3 classes). Primary outcome was MMD reduction for all studies except LIBERTY
EM episodic migraine, CM chronic migraine, MMD mean monthly migraine day, NS non-significant