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

Conditions

• Migraine

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Study Details

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.

Key Dates

Start date

Jan 10, 2023

Status verified

Dec 2025

Primary completion

Jan 31, 2036

Completion

Jan 31, 2036

Study Design

Enrollment

1,884 participants (estimated)

Arms

• Arm: 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.
• Arm: 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.
• Arm: 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.

Primary Outcome Measure

Major Congenital Malformations (MCMs) [ Time Frame: Up through the first 12 months of life ]

Central Contacts

• EMPRESS Pregnancy Call Center
  833-782-7241
  [email protected]

Locations (1)

Find similar trials in Durham, NC

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