Clinical trial NCT05158894: Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) or Qulipta (Atogepant) During Pregnancy
Official title: The Ubrelvy and Qulipta Pregnancy Exposure Registry EMPRESS: An Observational, Prospective Study to Assess the Safety of Ubrelvy (Ubrogepant) and Qulipta (Atogepant) During Pregnancy
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Keywords: Migraine
Ubrelvy
Ubrogepant
Atogepant
Qulipta
MED-EPI-NEU-0649
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2021-12-15
Enrollment: 1884
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: The study population consists of pregnant women, residing in the US and at least 18 years of age, and live born infants resulting from enrolled pregnancies. Participating women must meet eligibility criteria, including criteria for either the exposure or comparator group.

Brief summary: 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 or Qulipta during pregnancy, as well as in 2 comparator groups.

Ubrelvy (ubrogepant) and Qulipta (atogepant) are approved drugs for the acute treatment of migraine in adults. Approximately 628 pregnant women with migraine exposed to Ubrelvy, 628 pregnant women with migraine exposed to Qulipta and 628 pregnant women with migraine in comparator group will be enrolled in this study in the United States.

Participants enrolled in the Ubrelvy-exposed group and Qulipta-exposed group will receive Ubrelvy and Qulipta respectively as prescribed by their physician.


Eligibility criteria: Inclusion Criteria:

* Within the United States or Canada.
* Qualify as a prospective enrollment, defined as currently pregnant.
* A diagnosis of migraine by the patient's health care provider (HCP).
* Provide contact information for the participant and her and her infant(s)', if applicable, HCPs.
* Authorize their HCP(s) to release maternal and infant medical information to the registry, upon request.
* Provide sufficient information to confirm eligibility for 1 of following:

  * Ubrelvy-exposed women with migraine: documented information indicating that at least 1 dose of Ubrelvy was taken during pregnancy, including the estimated number of administrations per trimester.
  * Qulipta-exposed women with migraine: documented information to indicating that at least 1 dose of Qulipta was taken during pregnancy, including start and stop date(s) of administration.
  * Internal comparator: Ubrelvy/Qulipta-unexposed pregnant women with migraine: documented information indicating that they have, a) never taken Ubrelvy and/or Qulipta, or b) discontinued Ubrelvy 2 days prior or Qulipta 5 days prior to conception.

Exclusion Criteria:

* Documentation of exposure to any gepants (acute or preventive) other than Ubrelvy and Qulipta, or CGRP monoclonal antibodies, from 5 halflives of the respective treatment prior to conception or at any point during pregnancy before enrollment.
* Women who are no longer pregnant (retrospective cases women for whom the pregnancy has already ended, and the outcome of pregnancy is known at the time of enrollment).
* For further clarification of inclusion/exclusion please contact the investigator to the end of this section in case anything is unclear to a potential patient, etc

Primary outcomes:
measure: Major Congenital Malformations (MCMs)
timeFrame: Up through the first 12 months of life
Secondary outcomes:
measure: Percentage of Pregnant Participants Experiencing Spontaneous Abortion
timeFrame: Up through the first 12 months of life
measure: Percentage of Pregnant Participants Experiencing Stillbirth
timeFrame: Up through the first 12 months of life
measure: Percentage of Pregnant Participants With Elective Termination
timeFrame: Up through the first 12 months of life
measure: Percentage of Pregnant Participants Experiencing Preeclampsia
timeFrame: Up through the first 12 months of life
measure: Percentage of Pregnant Participants Experiencing Eclampsia
timeFrame: Up through the first 12 months of life
measure: Percentage of Pregnant Participants Experiencing Gestational Hypertension
timeFrame: Up through the first 12 months of life
measure: Percentage of Pregnant Participants Experiencing Gestational Diabetes
timeFrame: Up through the first 12 months of life
measure: Percentage of Infants Experiencing Preterm Birth
timeFrame: Up through the first 12 months of life
measure: Percentage of Infants Experiencing Small for Gestational Age (SGA) Birth
timeFrame: Up through the first 12 months of life
measure: Percentage of Infants Experiencing Minor Malformations
timeFrame: Up through the first 12 months of life
measure: Percentage of Infants With Age-appropriate Infant Growth and Development
timeFrame: Up through the first 12 months of life
Other outcomes:
Locations:
city: Durham
country: United States
facility: Iqvia /Id# 266904
state: North Carolina
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: