Table 1.

Characteristics of the included studies

Included trials	Location(s); Study design	Eligibility criteria	Gender(male/female) mean age (years)		Migraine attacks per month		Medication dosage	Study period	Efficacy outcomes		Safety outcomes
			Control	Trial	Control	Trial			Primary	Secondary
Goadsby P J et al., 2020	Multinational RCT	ICHD-3 beta	32/154; 40.5± 11.7	79/560; 40.07± 12.33	7·8 ± 2·5	7.6 ± 2.5	10 mg QD 30 mg QD 60 mg QD 30 mg BID 60 mg BID	12Weeks	MMDs	MHDs; acute medication use days; ≥50% reduction in MMDs	TEAEs; treatment-related TEAEs; serious TEAEs; treatment-related serious TEAE; nausea; upper respiratory tract infection; nasopharyngitis; constipation; urinary tract infection; fatigue
Ailani J et al., 2021	Multinational RCT	ICHD-3	24/198; 40.3± 12.8	77/603; 42.01± 12.03	7.5 ± 2.4	7.7 ± 2.4	10 mg QD 30 mg QD 60 mg QD	12Weeks	MMDs	MHDs; acute medication use days; ≥50% reduction in MMDs	TEAEs; treatment-related TEAEs; serious TEAEs; treatment-related serious TEAE; nausea; upper respiratory tract infection; nasopharyngitis; constipation; urinary tract infection; fatigue
Pozo-Rosich P et al., 2023	Multinational RCT	ICHD-3	30/225; 42.0± 12.4	66/452; 42.15± 12.10	18.9 ± 4.8	18.9 ± 5.2	60 mg QD 30 mg BID	12Weeks	MMDs	MHDs; acute medication use days; ≥50% reduction in MMDs	TEAEs; treatment-related TEAEs; serious TEAEs; nausea; upper respiratory tract infection; nasopharyngitis; constipation; urinary tract infection; fatigue
Tassorelli C et al., 2024	Multinational RCT	ICHD-3	16/141; 43.4± 10.3	17/139; 40.9± 10.7	9·3 ± 2·4	9·1 ± 2·3	60 mg QD	12Weeks	MMDs	MHDs; acute medication use days; ≥50% reduction in MMDs	TEAEs; treatment-related TEAEs; serious TEAEs; nausea; nasopharyngitis; constipation; urinary tract infection

Data are mean ± SD. RCT, randomized controlled trial; ICHD, the International Classification of Headache Disorders; QD, quaque die, once daily; BID, both in die, twice daily; MMDs, Monthly migraine days; MHDs, Monthly headache days; TEAEs, treatment-emergent adverse events