Efficacy, Safety, and Tolerability of Atogepant for the Prevention of Chronic Migraine

Summary

This study evaluated the efficacy, safety and tolerability of atogepant in participants with chronic migraine. This study included a 12-week treatment period.

Timeline

Start

2019-03-11

Primary completion

2022-01-20

Completion

2022-01-20

Publications

• Schlachter L, Stodtmann S, Voelkner A, Jonsson F, Lagraauw HM, Boinpally RR. Population Pharmacokinetics of Atogepant for the Prevention of Migraine. Clin Pharmacokinet. 2026 Jan;65(1):149-164. doi: 10.1007/s40262-025-01566-5. Epub 2025 Nov 12.
• UpToDate(R). Nurse Pract. 2023 Jul 1;48(7):16. doi: 10.1097/01.NPR.0000000000000072. No abstract available.
• Goadsby PJ, Jurgens TP, Brand-Schieber E, Nagy K, Liu Y, Boinpally R, Stodtmann S, Trugman JM. Efficacy of ubrogepant and atogepant in males and females with migraine: A secondary analysis of randomized clinical trials. Cephalalgia. 2025 Feb;45(2):3331024251320610. doi: 10.1177/03331024251320610.
• Lipton RB, Gandhi P, Tassorelli C, Reuter U, Harriott AM, Holle-Lee D, Gottschalk CH, Neel B, Liu Y, Guo H, Stokes J, Nagy K, Dabruzzo B, Smith JH. Early Improvements With Atogepant for the Preventive Treatment of Migraine: Results From 3 Randomized Phase 3 Trials. Neurology. 2025 Jan 28;104(2):e210212. doi: 10.1212/WNL.0000000000210212. Epub 2024 Dec 23.
• Peterlin BL, Bond DS, Ailani J, Dodick DW, Liu Y, De Abreu Ferreira R, Smith JH, Dabruzzo B, Goadsby PJ, Trugman JM. Weight loss with atogepant during the preventive treatment of migraine: A pooled analysis. Cephalalgia. 2024 Dec;44(12):3331024241299753. doi: 10.1177/03331024241299753.
• Gottschalk C, Gandhi P, Pozo-Rosich P, Christie S, Tassorelli C, Stokes J, Liu Y, Luo L, Nagy K, Trugman JM, Lipton RB. Effect of preventive treatment with atogepant on quality of life, daily functioning, and headache impact across the spectrum of migraine: Findings from three double-blind, randomized, phase 3 trials. Cephalalgia. 2024 Dec;44(12):3331024241300305. doi: 10.1177/03331024241300305.
• Goadsby PJ, Friedman DI, Holle-Lee D, Demarquay G, Ashina S, Sakai F, Neel B, Gandhi P, Dabruzzo B, Smith JH, Liu Y, Trugman JM. Efficacy of Atogepant in Chronic Migraine With and Without Acute Medication Overuse in the Randomized, Double-Blind, Phase 3 PROGRESS Trial. Neurology. 2024 Jul 23;103(2):e209584. doi: 10.1212/WNL.0000000000209584. Epub 2024 Jun 26.
• Pozo-Rosich P, Ailani J, Ashina M, Goadsby PJ, Lipton RB, Reuter U, Guo H, Schwefel B, Lu K, Boinpally R, Miceli R, De Abreu Ferreira R, McCusker E, Yu SY, Severt L, Finnegan M, Trugman JM. Atogepant for the preventive treatment of chronic migraine (PROGRESS): a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet. 2023 Sep 2;402(10404):775-785. doi: 10.1016/S0140-6736(23)01049-8. Epub 2023 Jul 26.
• Boinpally R, McNamee B, Yao L, Butler M, McGeeney D, Borbridge L, Periclou A. A Single Supratherapeutic Dose of Atogepant Does Not Affect Cardiac Repolarization in Healthy Adults: Results From a Randomized, Single-Dose, Phase 1 Crossover Trial. Clin Pharmacol Drug Dev. 2021 Sep;10(9):1099-1107. doi: 10.1002/cpdd.940. Epub 2021 May 4.
• Min KC, Kraft WK, Bondiskey P, Colon-Gonzalez F, Liu W, Xu J, Panebianco D, Mixson L, Dockendorf MF, Matthews CZ, Boinpally R. Atogepant Is Not Associated With Clinically Meaningful Alanine Aminotransferase Elevations in Healthy Adults. Clin Transl Sci. 2021 Mar;14(2):599-605. doi: 10.1111/cts.12917. Epub 2020 Nov 24.

Drugs

Indications