Table 1 Eptinezumab clinical studies conducted in patients with migraine
Study | Phase | Number Treated | Study Design | Study Drugs/Doses | Dosing Frequency | Scheduled Post-Dose Visits |
|---|---|---|---|---|---|---|
NCT01772524 [12] | 1b | 163 (EM) | Double-blind, randomized, placebo-controlled, parallel group | Eptinezumab 1000 mg or placebo | Single dose (day 0) | Week 2 and months 1, 2, 3, and 6 |
NCT02275117 [13] | 2 | 616 (CM) | Double-blind, randomized, placebo-controlled, parallel group | Eptinezumab 10 mg, 30 mg, 100 mg, or 300 mg, or placebo | Single dose (day 0) | Months 1, 2, 3, 6, and 9, and week 49 |
PROMISE-1 (NCT02559895) [14] | 3 | 888 (EM) | Double-blind, randomized, placebo-controlled, parallel group | Eptinezumab 30 mg, 100 mg, or 300 mg, or placebo | Day 0 and every 12 weeks through week 36 (4 doses) | Months 1, 2, 3, 4, 5, 6, 7, 9, 12, and 14 |
PROMISE-2 (NCT02974153) [15] | 3 | 1072 (CM) | Double-blind, randomized, placebo-controlled, parallel group | Eptinezumab 100 mg or 300 mg or placebo | Day 0 and week 12 (2 doses) | Week 2 and months 1, 2, 3, 4, 5, 6, and 8 |
PREVAIL (NCT02985398) [16] | 3 | 128 (CM) | Open-label, uncontrolled | Eptinezumab 300 mg | Day 0 and every 12 weeks through week 84 (8 doses)a | Week 2 and months 1, 2, 3, 6, 9, 12, 15, 18, 21, and 26 |