drugset / Trial / NCT04418765
A Study to Evaluate the Efficacy and Safety of Eptinezumab for the Prevention of Migraine in Participants That Are Not Helped by Previous Preventive Treatments
RandomizedParallel-groupDouble-blindTreatment
Summary
Evaluation of eptinezumab in the prevention of migraine in participants with unsuccessful prior preventive treatments.
Timeline
- Start
- 2020-06-01
- Primary completion
- 2021-07-15
- Completion
- 2022-09-15
Outcome
Met primary endpoint
registry Placebo vs Eptinezumab 300 mg; p <0.0001; Mean Difference (Final Values) -3.2 (95% CI -3.9 to -2.5) NCT04418765 ↗
registry Placebo vs Eptinezumab 100 mg; p <0.0001; Mean Difference (Final Values) -2.7 (95% CI -3.4 to -2.0) NCT04418765 ↗
release “The DELIVER study met its primary endpoint of demonstrating statistically significant superiority of Vyepti versus placebo” lundbeck.com ↗
Publications
- Ailani J, Ashina M, Awad SF, Lee XY, Boserup LP, Soni-Brahmbhatt S, Sperling B, Lipton RB. Long-Term Improvements Following Initial Migraine Response in Eptinezumab-Treated Participants With Migraine for Whom 2-4 Prior Preventive Treatments Have Failed. Eur J Neurol. 2026 Mar;33(3):e70571. doi: 10.1111/ene.70571.
- Pozo-Rosich P, Tassorelli C, Boserup LP, Awad SF, Lee XY, Ailani J. Sustained Efficacy of Eptinezumab in Participants with Migraine for Whom Prior Preventive Treatments Failed and Who Self-reported Psychiatric Comorbidities: Post Hoc Analysis of the Placebo-controlled DELIVER Trial. Neurol Ther. 2026 Apr;15(2):753-774. doi: 10.1007/s40120-026-00893-4. Epub 2026 Feb 11.
- Tassorelli C, Starling AJ, Awad SF, Lee XY, Boserup LP, Asher D, Soni-Brahmbhatt S, Sperling B, Goadsby PJ. Early and Sustained Shift in Headache Day Frequency Following Eptinezumab Treatment in Adults With Migraine for Whom 2-4 Previous Preventive Treatments Have Failed: A Post Hoc Analysis of the Randomized DELIVER Trial. Eur J Neurol. 2025 Dec;32(12):e70460. doi: 10.1111/ene.70460.
- Barbanti P, Awad SF, Rae-Espinoza H, Regnier SA, Lee XY, Goadsby PJ. Impact of eptinezumab on work productivity beyond reductions in monthly migraine days: post hoc analysis of the DELIVER trial. J Patient Rep Outcomes. 2024 Dec 18;8(1):146. doi: 10.1186/s41687-024-00813-w.
- Jonsson L, Awad SF, Regnier SA, Talon B, Kymes S, Lee XY, Goadsby PJ. Structural equation modeling for identifying the drivers of health-related quality of life improvement experienced by patients with migraine receiving eptinezumab. J Headache Pain. 2024 Mar 28;25(1):45. doi: 10.1186/s10194-024-01752-z.
- Pozo-Rosich P, Ashina M, Tepper SJ, Jensen S, Boserup LP, Josiassen MK, Sperling B. Eptinezumab Demonstrated Efficacy Regardless of Prior Preventive Migraine Treatment Failure Type: Post Hoc Analyses of the DELIVER Study. Neurol Ther. 2024 Apr;13(2):339-353. doi: 10.1007/s40120-023-00575-5. Epub 2024 Jan 18.
- Ashina M, Tepper SJ, Gendolla A, Sperling B, Ettrup A, Josiassen MK, Starling AJ. Long-term effectiveness of eptinezumab in patients with migraine and prior preventive treatment failures: extension of a randomized controlled trial. J Headache Pain. 2023 Nov 20;24(1):155. doi: 10.1186/s10194-023-01688-w.
- Pinto S, Oliveira Santos M, Gromicho M, Swash M, de Carvalho M. Impact of diabetes mellitus on the respiratory function of amyotrophic lateral sclerosis patients. Eur J Neurol. 2024 Feb;31(2):e16129. doi: 10.1111/ene.16129. Epub 2023 Nov 13.
- Jonsson L, Regnier SA, Kymes S, Awad SF, Talon B, Lee XY, Goadsby PJ. Estimating treatment effects on health utility scores for patients living with migraine: a post hoc analysis of the DELIVER trial. Expert Rev Pharmacoecon Outcomes Res. 2023 Jul-Dec;23(7):797-803. doi: 10.1080/14737167.2023.2219898. Epub 2023 Jun 2.
- Ashina M, Lanteri-Minet M, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B, Pozo-Rosich P. Efficacy and safety of eptinezumab for migraine prevention in patients with prior preventive treatment failures: subgroup analysis of the randomized, placebo-controlled DELIVER study. Cephalalgia. 2023 May;43(5):3331024231170807. doi: 10.1177/03331024231170807.
- Goadsby PJ, Barbanti P, Lambru G, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Eptinezumab improved patient-reported outcomes and quality of life in patients with migraine and prior preventive treatment failures. Eur J Neurol. 2023 Apr;30(4):1089-1098. doi: 10.1111/ene.15670. Epub 2023 Jan 21.
- Barbanti P, Goadsby PJ, Lambru G, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Effects of eptinezumab on self-reported work productivity in adults with migraine and prior preventive treatment failure in the randomized, double-blind, placebo-controlled DELIVER study. J Headache Pain. 2022 Dec 2;23(1):153. doi: 10.1186/s10194-022-01521-w.
- Ashina M, Lanteri-Minet M, Pozo-Rosich P, Ettrup A, Christoffersen CL, Josiassen MK, Phul R, Sperling B. Safety and efficacy of eptinezumab for migraine prevention in patients with two-to-four previous preventive treatment failures (DELIVER): a multi-arm, randomised, double-blind, placebo-controlled, phase 3b trial. Lancet Neurol. 2022 Jul;21(7):597-607. doi: 10.1016/S1474-4422(22)00185-5.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Eptinezumab | Monoclonal antibody | 100 mg | Intravenous |
| Subject | Eptinezumab | Monoclonal antibody | 300 mg | Intravenous |