Eptinezumab in Participants With Episodic Cluster Headache

Summary

The purpose of this study is to evaluate the efficacy of eptinezumab in participants with episodic Cluster Headache (eCH)

Timeline

Start

2020-12-23

Primary completion

2023-06-14

Completion

2023-10-05

Outcome

Missed primary endpoint

registry analysis (superiority test); Eptinezumab vs Placebo; p = 0.5048; Mean Difference (Final Values) 0.7 (95% CI -1.3 to 2.6) NCT04688775 ↗

paper eptinezumab did not significantly reduce the number of attacks vs placebo PMID 40388178 ↗

Publications

• Jensen RH, Tassorelli C, Tepper SJ, Charles A, Goadsby PJ, Snoer AH, Sperling B, Krog Josiassen M, Borgen Linander C, Ettrup A, Boneva N. Efficacy and Safety of Eptinezumab in Episodic Cluster Headache: A Randomized Clinical Trial. JAMA Neurol. 2025 Jul 1;82(7):706-714. doi: 10.1001/jamaneurol.2025.1317.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Eptinezumab	Monoclonal antibody	400 mg	Intravenous

Indications