Table 3.

Studies of migraine preventive therapies reporting an early onset of preventive effect^*: clinical efficacy endpoints: impact on function, disability, and quality of life.

Study	Study design	Population	Dose	Impact
Fremanezumab
NCT02621931 (HALO-CM)38,41,42	Phase III, R, DB, PC	1130 adults (18–70 years) with CM	Quarterly (675 mg) or monthly (675/225/225 mg)	• Percentage of patients reporting PGIC ⩾ 5 at Week 4 was 53% and 54% for quarterly and monthly fremanezumab administration, respectively (versus 31% for placebo, p < 0.0001 for both comparisons) • Improved HIT-6 total scores 4 weeks after the final dose more than placebo [−6.4, −6.8 versus −4.5 (both p < 0.001 versus placebo)] in the total population • Improved MSQ-RFP, -RFR, and -EF scores more than placebo at Week 4 in the total population (all p < 0.0001) ○ MSQ-RFR score: 19.1, 19.4 versus 12.0 (quarterly, monthly, placebo, respectively) ○ MSQ-RFP score: 15.3, 15.8 versus 9.4 ○ MSQ-EF score: 19.1, 19.5 versus 12.1
NCT02629861 (HALO EM) 24	Phase III, DB, R, DB, PC	875 adults (18–70 years) with EM	Monthly (225 mg) and quarterly (675 mg)	• Improved MIDAS scores at Week 4 ○ −24.6, −23.0 versus −17.5 (p < 0.001 and p = 0.002, respectively)
Eptinezumab
NCT0177252431	Phase II, R, DB, PC	163 adults (18–55 years) with EM	1000 mg	• Improved HIT-6 total score by −10.2 at Week 4 [versus −5.8 with placebo; difference (95% CI), −4.4 (−7.2 to −1.6)] • Improved MSQ-RFP score by 29.3 at Week 4 [versus 19.9 with placebo; difference (95% CI), 9.4 (1.8 to 17.0)] • Improved MSQ-RFR score by 21.1 at Week 4 [versus 16.3 with placebo; difference (95% CI), 4.8 (−2.6 to 12.2)] • Improved MSQ-EF score by 25.1 at Week 4 [versus 19.4 with placebo; difference (95% CI), 5.7 (−3.1 to 14.5)]
NCT02559895 (PROMISE-1) 43	Phase III, R, DB, PC	888 adults (18–75 years) with EM	30, 100, and 300 mg	• Improved SF-36 domains that were impaired or below normative values at baseline (bodily pain, role-physical, and social functioning), beginning as early as Week 4 ○ Bodily pain: Improvements ranged from 3.8 to 4.1 (eptinezumab) versus 2.3 (placebo) at Week 4 ○ Role-physical: Improvements ranged from 2.1 to 2.6 (eptinezumab) versus 1.5 (placebo) at Week 4 ○ Social functioning: Improvements ranged from 1.7 to 3.0 (eptinezumab) versus 1.8 (placebo) versus placebo

CI, confidence interval; chronic migraine; DB, double-blind; EM, episodic migraine; HIT-6, 6-item Headache Impact Test; MIDAS, Migraine Disability Assessment; MSQ-EF, Migraine-Specific Quality-of-Life Questionnaire–Emotional Function; MSQ-RFP, Migraine-Specific Quality-of-Life Questionnaire–Role Function Preventive; MSQ-RFR, Migraine-Specific Quality-of-Life Questionnaire–Role Function Restrictive; PC, placebo controlled; R, randomized; WMD, weekly migraine day

^*Early was defined as the demonstration of preventive benefits within 1 month (30 days) post-initiation.