Eptinezumab as Preventive Treatment of Migraine in Adults With Migraine

NCT04921384 ↗

Phase 3 Completed 981 enrolled H. Lundbeck A/S

RandomizedParallel-groupDouble-blindTreatment

Summary

This study evaluates the efficacy of eptinezumab to prevent migraine in participants with chronic migraine.

Timeline

Start: 2021-05-29
Primary completion: 2024-10-01
Completion: 2025-02-17

Outcome

Met primary endpoint

paper Both eptinezumab doses met the primary and all key secondary efficacy endpoints. PMID 41091746 ↗

paper Between-group differences were -2.4 for eptinezumab 100 mg versus placebo (p < 0.0001) and -2.7 for eptinezumab 300 mg versus placebo (p < 0.0001). PMID 41091746 ↗

Publications

Yu S, Matsumori Y, Kim BK, Gryglas-Dworak A, Giorgadze G, Pozo-Rosich P, Krog Josiassen M, Ranc K, Ettrup A, Mittoux A, Sperling B, Takeshima T. Efficacy and safety of eptinezumab in a predominantly Asian population with chronic migraine: Results of the randomized, double-blind, placebo-controlled SUNRISE trial. Cephalalgia. 2025 Oct;45(10):3331024251386095. doi: 10.1177/03331024251386095. Epub 2025 Oct 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eptinezumab	Monoclonal antibody	100 mg	Intravenous
Subject	Eptinezumab	Monoclonal antibody	300 mg	Intravenous