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NCT Number: NCT05158894

Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) or Qulipta (Atogepant) During Pregnancy

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.

Recruiting

Interested in participating?

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Ottawa Hospital Research Institute /ID# 280174, Ottawa, Ontario, Canada

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Major Congenital Malformations (MCMs)

    Time frame: Up through the first 12 months of life

    An MCM is defined as any major structural or chromosomal defect in live born infants, stillbirths/fetal losses of any gestational age.

Secondary outcomes

  1. Percentage of Pregnant Participants Experiencing Spontaneous Abortion

    Time frame: Up through the first 12 months of life

    Recognized spontaneous abortion (SAB): loss of an embryo/fetus due to natural causes prior to 20 weeks of gestation.

  2. Percentage of Pregnant Participants Experiencing Stillbirth

    Time frame: Up through the first 12 months of life

    A fetal death occurring at 20 gestation weeks or greater, or if gestational age is unknown, a fetus weighing 350 g or more.

  3. Percentage of Pregnant Participants With Elective Termination

    Time frame: Up through the first 12 months of life

    Elective termination is voluntary interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health, or due to abnormalities.

  4. Percentage of Pregnant Participants Experiencing Preeclampsia

    Time frame: Up through the first 12 months of life

    Preeclampsia is the presence of hypertension on 2 occasions at least 4 hours apart after 20 weeks gestation (in a woman with a previously normal blood pressure) and proteinuria, or new-onset hypertension accompanied by thrombocytopenia, renal insufficiency, impaired liver function, pulmonary edema, or cerebral or visual symptoms.

  5. Percentage of Pregnant Participants Experiencing Eclampsia

    Time frame: Up through the first 12 months of life

    Eclampsia is defined as new-onset seizures (tonic-clonic, focal, or multifocal) in the absence of other causative conditions such as epilepsy, cerebral arterial ischemia and infarction, intracranial hemorrhage, or drug use.

  6. Percentage of Pregnant Participants Experiencing Gestational Hypertension

    Time frame: Up through the first 12 months of life

    Gestational hypertension is defined as high blood pressure (Elevated: systolic between 120-129 mm Hg and diastolic less than 80 mm Hg; Stage 1 hypertension: systolic between 130-139 mm Hg or diastolic between 80-89 mm Hg; Stage 2 hypertension: systolic at least 140 mm Hg or diastolic at least 90 mm Hg) associated with pregnancy.

  7. Percentage of Pregnant Participants Experiencing Gestational Diabetes

    Time frame: Up through the first 12 months of life

    Gestational diabetes is generally characterized by the development of carbohydrate intolerance with first onset or first recognition during pregnancy; a record of an oral glucose tolerance test during pregnancy will also be accepted for data collection, where available.

  8. Percentage of Infants Experiencing Preterm Birth

    Time frame: Up through the first 12 months of life

    Preterm birth is defined as an infant born at gestational age <37 weeks.

  9. Percentage of Infants Experiencing Small for Gestational Age (SGA) Birth

    Time frame: Up through the first 12 months of life

    SGA at birth based on health care provider (HCP) report, typically defined as birthweight <=10th percentile for sex and gestational age.

  10. Percentage of Infants Experiencing Minor Malformations

    Time frame: Up through the first 12 months of life

    Minor malformations not previously reported.

  11. Percentage of Infants With Age-appropriate Infant Growth and Development

    Time frame: Up through the first 12 months of life

    Age-appropriate progress on developmental milestones based on the overall assessment by the infant's HCP (e.g., appropriate or delayed) up to 1 year of age.

Study contacts

Contact information is provided by the study sponsor or research team.

EMPRESS Pregnancy Call Center

CONTACT

[email protected]

833-782-7241

Sponsors and collaborators

Lead sponsor

AbbVie

Industry

Registry information

Official study 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

Acronym: EMPRESS

Important dates

Study start
2023
Primary completion
2036
Study completion
2036
First posted
Dec 15, 2021
Registry last updated
Dec 15, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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