Study to Evaluate Oral Ubrogepant in the Acute Treatment of Migraine During the Prodrome in Adult Participants

Summary

Study to Evaluate the Efficacy, Safety, and Tolerability of Oral Ubrogepant in the Acute Treatment of Migraine When Administered During the Prodrome

Timeline

Start

2020-08-21

Primary completion

2022-04-19

Completion

2022-04-19

Outcome

Met primary endpoint

registry analysis (superiority test); Ubrogepant 100 mg; p <.0001; Odds Ratio (OR) 2.09 (95% CI 1.63 to 2.69) NCT04492020 ↗

release “The Phase 3 study, PRODROME, showed that UBRELVY given during the prodrome significantly reduced the likelihood of development of moderate or severe headache” abbvie.com ↗

Publications

• 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.
• Schwedt TJ, Lipton RB, Goadsby PJ, Chiang CC, Klein BC, Hussar C, Liu C, Yu SY, Finnegan M, Trugman JM. Characterizing Prodrome (Premonitory Phase) in Migraine: Results From the PRODROME Trial Screening Period. Neurol Clin Pract. 2025 Feb;15(1):e200359. doi: 10.1212/CPJ.0000000000200359. Epub 2024 Oct 8.
• Lipton RB, Harriott AM, Ma JY, Smith JH, Stokes J, Gandhi P, Jariwala-Parikh K, Jensen GS, Trugman JM, Dodick DW. Effect of Ubrogepant on Patient-Reported Outcomes When Administered During the Migraine Prodrome: Results From the Randomized PRODROME Trial. Neurology. 2024 Sep 24;103(6):e209745. doi: 10.1212/WNL.0000000000209745. Epub 2024 Aug 28.
• Dodick DW, Goadsby PJ, Schwedt TJ, Lipton RB, Liu C, Lu K, Yu SY, Severt L, Finnegan M, Trugman JM. Ubrogepant for the treatment of migraine attacks during the prodrome: a phase 3, multicentre, randomised, double-blind, placebo-controlled, crossover trial in the USA. Lancet. 2023 Dec 16;402(10419):2307-2316. doi: 10.1016/S0140-6736(23)01683-5. Epub 2023 Nov 15.

Drugs

Evaluation	Drug	Modality	Dose	Route
Subject	Ubrogepant	Small molecule	100 mg	Oral

Indications