MigraineEMPRESSNCT05158894
Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) or Qulipta (Atogepant) During Pregnancy
An observational study of Migraine, run by AbbVie at 2 sites in 2 countries.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Migraine
- How many people
- 1,884 participants
- Where
- 2 sitesin 2 countries
- Study dates
- 10 Jan 2023to Jan 2036
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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:
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- 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.
Who cannot join
- 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
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
United States1 site, 1 recruiting
- Recruiting
Iqvia /Id# 266904
Durham, North Carolina, 27703-8426
Canada1 site, 1 recruiting
- Recruiting
Ottawa Hospital Research Institute /ID# 280174
Ottawa, Ontario, K1Y 4E9
Site Coordinator, 8444670844, empressstudycanada@ohri.ca
About this study
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
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.
- Conditions
- Migraine
- Keywords
- Migraine, Ubrelvy, Ubrogepant, Atogepant, Qulipta, MED-EPI-NEU-0649
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ubrelvy-Exposed Women With Migraine | Pregnant women with migraine who took at least 1 dose of Ubrelvy, the exposure of interest, at any time during pregnancy as part of routine care. | |
| Qulipta-Exposed Women With Migraine | Pregnant women with migraine who took at least 1 dose of Qulipta, the exposure of interest, at any time during pregnancy as part of routine care. | |
| Ubrelvy/Qulipta-Unexposed Women With Migraine | Pregnant women with migraine who have never taken Ubrelvy and/or Qulipta, OR discontinued Ubrelvy 2 days prior or Qulipta 5 days prior to conception. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Major Congenital Malformations (MCMs)
An MCM is defined as any major structural or chromosomal defect in live born infants, stillbirths/fetal losses of any gestational age.
Measured: Up through the first 12 months of life
Secondary outcomes (11)
Percentage of Pregnant Participants Experiencing Spontaneous Abortion
Recognized spontaneous abortion (SAB): loss of an embryo/fetus due to natural causes prior to 20 weeks of gestation.
Measured: Up through the first 12 months of life
Percentage of Pregnant Participants Experiencing Stillbirth
A fetal death occurring at 20 gestation weeks or greater, or if gestational age is unknown, a fetus weighing 350 g or more.
Measured: Up through the first 12 months of life
Percentage of Pregnant Participants With Elective Termination
Elective termination is voluntary interruption of pregnancy, including pregnancy termination that occurs electively, to preserve maternal health, or due to abnormalities.
Measured: Up through the first 12 months of life
Percentage of Pregnant Participants Experiencing Preeclampsia
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.
Measured: Up through the first 12 months of life
Percentage of Pregnant Participants Experiencing Eclampsia
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.
Measured: Up through the first 12 months of life
Percentage of Pregnant Participants Experiencing Gestational Hypertension
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.
Measured: Up through the first 12 months of life
Percentage of Pregnant Participants Experiencing Gestational Diabetes
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.
Measured: Up through the first 12 months of life
Percentage of Infants Experiencing Preterm Birth
Preterm birth is defined as an infant born at gestational age <37 weeks.
Measured: Up through the first 12 months of life
Percentage of Infants Experiencing Small for Gestational Age (SGA) Birth
SGA at birth based on health care provider (HCP) report, typically defined as birthweight <=10th percentile for sex and gestational age.
Measured: Up through the first 12 months of life
Percentage of Infants Experiencing Minor Malformations
Minor malformations not previously reported.
Measured: Up through the first 12 months of life
Percentage of Infants With Age-appropriate Infant Growth and Development
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.
Measured: Up through the first 12 months of life
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Dec 2021
- Study start10 Jan 2023
- Primary completionJan 2036 (estimated)
- Study completionJan 2036 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,884 participants (estimated)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05158894
- Sponsor's protocol ID
- P22-392
- Other IDs
- MED-EPI-NEU-0649
- Acronym
- EMPRESS
- Status last verified
- Dec 2025
- First submitted
- 2 Dec 2021
- Last updated
- 15 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05158894
- Acronym / sponsor ID
- EMPRESS / P22-392
- Conditions
- Migraine
- Keywords
- Migraine, Ubrelvy, Ubrogepant, Atogepant, Qulipta, MED-EPI-NEU-0649
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 1,884 participants (estimated)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 10 Jan 2023 (actual)
- Primary completion
- Jan 2036 (estimated)
- Study completion
- Jan 2036 (estimated)
- First posted
- 15 Dec 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Ubrelvy-Exposed Women With Migraine | – | –Pregnant women with migraine who took at least 1 dose of Ubrelvy, the exposure of interest, at any time during pregnancy as part of routine care. |
| Qulipta-Exposed Women With Migraine | – | –Pregnant women with migraine who took at least 1 dose of Qulipta, the exposure of interest, at any time during pregnancy as part of routine care. |
| Ubrelvy/Qulipta-Unexposed Women With Migraine | – | –Pregnant women with migraine who have never taken Ubrelvy and/or Qulipta, OR discontinued Ubrelvy 2 days prior or Qulipta 5 days prior to conception. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (9 listed)
- 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.
Key exclusion criteria (3 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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.
11 secondary outcomes
Percentage of Pregnant Participants Experiencing Spontaneous Abortion
Time frame: Up through the first 12 months of life
Percentage of Pregnant Participants Experiencing Stillbirth
Time frame: Up through the first 12 months of life
Percentage of Pregnant Participants With Elective Termination
Time frame: Up through the first 12 months of life
Percentage of Pregnant Participants Experiencing Preeclampsia
Time frame: Up through the first 12 months of life
Percentage of Pregnant Participants Experiencing Eclampsia
Time frame: Up through the first 12 months of life
Percentage of Pregnant Participants Experiencing Gestational Hypertension
Time frame: Up through the first 12 months of life
Percentage of Pregnant Participants Experiencing Gestational Diabetes
Time frame: Up through the first 12 months of life
Percentage of Infants Experiencing Preterm Birth
Time frame: Up through the first 12 months of life
Percentage of Infants Experiencing Small for Gestational Age (SGA) Birth
Time frame: Up through the first 12 months of life
Percentage of Infants Experiencing Minor Malformations
Time frame: Up through the first 12 months of life
Percentage of Infants With Age-appropriate Infant Growth and Development
Time frame: Up through the first 12 months of life
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
ABBVIE INC. study director
AbbVie
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by AbbVie at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact EMPRESS Pregnancy Call Center (833-782-7241, empresspregnancyregistry@iqvia.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Major Congenital Malformations (MCMs) (time frame: Up through the first 12 months of life). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.