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. 2022 Apr 14;19(3):922–930. doi: 10.1007/s13311-022-01230-x

Table 4.

Summary of galcanezumab RCTs

Study Phase Migraine/N Study period Primary outcome
NCT01625988 Dodick et al. (2014) [35] II

EM

N = 218

3 months

placebo: − 3.0

150 mg: − 4.2 (p = 0.003

NCT02959177 Sakai et al. (2020) [36] II

EM

N = 915

6 months

placebo: − 0.59

120 mg: − 3.60 (p < 0.001)

240 mg: − 3.36 (p < 0.001)

NCT02614183 Stauffer et al. (2018) (EVOLVE-1) [37] III

EM

N = 858

6 months

placebo: − 2.8

120 mg: − 4.7 (p < 0.001)

240 mg: − 4.6 (p < 0.001)

NCT02614196 Skljarevski et al. (2018) (EVOLVE-2) [38] III

EM

N = 915

6 months

placebo: − 2.3

120 mg: − 4.3 (p < 0.001)

240 mg: − 4.2 (p < 0.001)

NCT02614261 Detke et al. (2018) (REGAIN) [39] III

CM

N = 1113

3 months

MHD reduction

placebo: − 2.7

120 mg: − 4.8 (p < 0.001)

240 mg: − 4.6 (p < 0.001)

NCT03559257 Mulleners et al. (2020) (CONQUER) [41] III

EM, CM

N = 462

3 months

placebo: − 1.0

120 mg: − 4.1 (p < 0.0001)

All studies required ≤ 2 classes of failed preventive treatments except REGAIN (≤ 3 classes) and CONQUER [24 classes]. Primary outcome was MMD reduction for all studies except REGAIN

EM episodic migraine, CM chronic migraine, MMD mean monthly migraine day, MHD mean monthly headache day