Included trials | Location (s); Study design | Eligibility criteria | Gender (male/female); mean age (years) | Migraine attacks per month | Drug doses | Primary efficacy outcomes at 2 h | Most frequent TEAEs | ||
---|---|---|---|---|---|---|---|---|---|
Control | Trial | Control | Trial | ||||||
Ferrari MD et al., 2010 [16] | Multinational; RCT | IHS 1.1 & 1.2.1 | 4/38; 40.3 | 13/75; 38.4 | 3.3 | 3.5 | 2.5–45 mg | Pain freedom, sustained pain free, other efficacy outcomes such as nausea, photophobia, phonophobia. | Dizziness, paresthesia, fatigue, sensation of heaviness, and feeling of relaxation |
Färkkilä M et al., 2012 [17] | Multinational; RCT | IHS 1.1 & 2.1 | 11/75; 40.5 ± 10.3 | 38/267; 40.2 ± 11.0 | 3.1 ± 1.6 | 3.3 ± 1.7 | 50, 100, 200, 400 mg | Pain free, headache response, other efficacy outcomes such as nausea, photophobia, phonophobia | Dizziness, paresthesia, fatigue, nausea, vertigo and somnolence |
Kuca B et al., 2018 [18] | USA; RCT | IHS 1.1 & 1.2.1 | 92/525; 42.4 ± 12.3 | 212/1027; 41.8 ± 11.9 | 5.1 ± 1.8 | 5.2 ± 2.1 | 100, 200 mg | Headache pain free, MBS free, other efficacy outcomes such as nausea, photophobia, phonophobia | Dizziness, paresthesia, fatigue, nausea, lethargy, and palpitations |
Goadsby PJ et al., 2019 [19] | Multinational; RCT | IHS 1.1 & 1.2.1 | 100/545; 42.6 ± 12.9 | 309/1629; 42.7 ± 12.8 | 5.5 ± 2.4 | 5.2 ± 2.1 | 50, 100, 200 mg | Headac he pain free, MBS free, other efficacy outcomes such as nausea, photophobia, phonophobia | Dizziness, paresthesia, fatigue, nausea, lethargy and somnolence |