Migraine is a common neurological disorder typically characterized by attacks of throbbing or pulsating headache on one side of the head of moderate to severe pain intensity. The purpose of this study is to evaluate fetal, maternal, and infant outcomes through 12 months of age among women exposed to Ubrelvy during pregnancy, as well as in 2 Ubrelvy-unexposed comparison groups. Ubrelvy (ubrogepant) is an approved drug for the acute treatment of migraine in adults. Approximately 560 pregnant women with migraine exposed to Ubrelvy and 560 pregnant women with migraine without exposure to Ubrelvy will be enrolled in this study in the United States. Participants enrolled in the Ubrelvy-exposed group will receive Ubrelvy as prescribed by their physician. There may be higher treatment burden for participants in this trial compared to their standard of care.
|Study Type :||Observational|
|Estimated Enrollment :||1120 participants|
|Official Title:||The Ubrelvy Pregnancy Exposure Registry: An Observational, Prospective Study to Assess the Safety of Ubrelvy (Ubrogepant) During Pregnancy|
|Actual Study Start Date :||December 31, 2022|
|Estimated Primary Completion Date :||September 29, 2034|
|Estimated Study Completion Date :||September 29, 2034|
Information not available for Arms and Intervention/treatment
|Ages Eligible for Study:||18 Years|
|Sexes Eligible for Study:||Female|
|Accepts Healthy Volunteers:||No|
Want to participate in this study, select a site at your convenience, send yourself email to get contact details and prescreening steps.
Not yet recruiting
Iqvia /Id# 244683
Durham, North Carolina, United States, 27703-8426