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

Migraine Clinical Trial

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05158894
• Other study ID #: P22-392
• Secondary ID: MED-EPI-NEU-0649
• Status: Recruiting
• Start date: January 10, 2023
• Est. completion date: September 29, 2034

Study information

• Verified date: March 2024
• Source: AbbVie
• Contact: EMPRESS Pregnancy Call Center
• Phone: +1-833-277-0206
• Email: empresspregnancyregistry[@]iqvia.com
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 1884
• Est. completion date: September 29, 2034
• Est. primary completion date: September 29, 2034
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 half-lives 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

Related Conditions & MeSH terms

• Migraine
• Migraine Disorders

Locations

Country	Name	City	State
United States	Iqvia /Id# 244683	Durham	North Carolina

Sponsors (1)

Lead Sponsor	Collaborator
AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	Up through the first 12 months of life
Secondary	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.	Up through the first 12 months of life
Secondary	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.	Up through the first 12 months of life
Secondary	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.	Up through the first 12 months of life
Secondary	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.	Up through the first 12 months of life
Secondary	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.	Up through the first 12 months of life
Secondary	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.	Up through the first 12 months of life
Secondary	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.	Up through the first 12 months of life
Secondary	Percentage of Infants Experiencing Preterm Birth	Preterm birth is defined as an infant born at gestational age <37 weeks.	Up through the first 12 months of life
Secondary	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.	Up through the first 12 months of life
Secondary	Percentage of Infants Experiencing Minor Malformations	Minor malformations not previously reported.	Up through the first 12 months of life
Secondary	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.	Up through the first 12 months of life

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