A Study to Evaluate the Efficacy and Safety of Eptinezumab Administered Intravenously in Participants Experiencing Acute Attack of Migraine

Summary

The purpose of this study is to evaluate the efficacy and safety of eptinezumab administered intravenously in participants experiencing an acute attack of migraine.

Timeline

Start

2019-11-07

Primary completion

2020-07-08

Completion

2020-07-08

Outcome

Met primary endpoint

registry analysis (other test); Eptinezumab vs Placebo; p = 0.0006; Hazard Ratio (HR) 1.54 (95% CI 1.20 to 1.98) NCT04152083 ↗

registry analysis (other test); Eptinezumab vs Placebo; p <0.0001; Hazard Ratio (HR) 1.75 (95% CI 1.41 to 2.19) NCT04152083 ↗

release “Patients receiving a 100 mg VYEPTI infusion during a migraine attack achieved co-primary endpoints” lundbeck.com ↗

release “The RELIEF study met co-primary endpoints of time to headache pain freedom (HR 1.54, p<0.001)” lundbeck.com ↗

Publications

• Cady R, Lipton RB, Buse DC, Josiassen MK, Lindsten A, Ettrup A. Optimization of acute medication use following eptinezumab initiation during a migraine attack: post hoc analysis of the RELIEF study. J Headache Pain. 2022 Jul 28;23(1):91. doi: 10.1186/s10194-022-01463-3.
• Ailani J, McAllister P, Winner PK, Chakhava G, Krog Josiassen M, Lindsten A, Sperling B, Ettrup A, Cady R. Rapid resolution of migraine symptoms after initiating the preventive treatment eptinezumab during a migraine attack: results from the randomized RELIEF trial. BMC Neurol. 2022 Jun 3;22(1):205. doi: 10.1186/s12883-022-02714-1.
• McAllister P, Winner PK, Ailani J, Buse DC, Lipton RB, Chakhava G, Josiassen MK, Lindsten A, Mehta L, Ettrup A, Cady R. Eptinezumab treatment initiated during a migraine attack is associated with meaningful improvement in patient-reported outcome measures: secondary results from the randomized controlled RELIEF study. J Headache Pain. 2022 Feb 7;23(1):22. doi: 10.1186/s10194-021-01376-7.
• Winner PK, McAllister P, Chakhava G, Ailani J, Ettrup A, Krog Josiassen M, Lindsten A, Mehta L, Cady R. Effects of Intravenous Eptinezumab vs Placebo on Headache Pain and Most Bothersome Symptom When Initiated During a Migraine Attack: A Randomized Clinical Trial. JAMA. 2021 Jun 15;325(23):2348-2356. doi: 10.1001/jama.2021.7665.

Drugs

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

Indications