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NCT05158894 · ClinicalTrials.gov registry record
Observational Study to Assess Adverse Events When Adult Female Participants Are Treated With Ubrelvy (Ubrogepant) or Qulipta (Atogepant) During Pregnancy
A clinical trial of Migraine, sponsored by AbbVie.
- Recruiting
- Registry status
- 1,884
- Enrollment target
- 2
- Study locations
NCT05158894: Recruiting study of Migraine, sponsored by AbbVie.
NCT05158894 is a study of Migraine that is actively recruiting participants, run by AbbVie. The registered enrollment target is 1,884 participants, above the 340-participant average among 102 other Migraine trials with a reported enrollment target (454% higher). The trial reports 2 study locations across 2 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT05158894, a study of Migraine, is actively recruiting participants, sponsored by AbbVie.
- RECRUITING
- Registry status
- 1,884 participants
- Enrollment target
- 2
- Study locations
Study 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.
Primary Outcome
An MCM is defined as any major structural or chromosomal defect in live born infants, stillbirths/fetal losses of any gestational age.
Conditions Studied
Study Locations (2)
North Carolina
- Iqvia /Id# 266904 - Durham
Ontario
- Ottawa Hospital Research Institute /ID# 280174 - Ottawa
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,884 participants |
| Start Date | 2023-01-10 |
| Est. Completion | 2036-01 |
What NCT05158894 shows while recruiting
NCT05158894 is an observational study that tracks outcomes without assigning an intervention. Its 1,884 participants enrollment target places it among the larger protocols in the corpus, above the 340-participant average among 102 other Migraine trials with a reported enrollment target (454% higher).
The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 0 interventions.
NCT05158894 reports a single indexed study location in North Carolina, Ontario.
Frequently Asked Questions
What is clinical trial NCT05158894 about?
NCT05158894 is a clinical study titled "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...
What is the current status of trial NCT05158894?
This trial is currently recruiting. The enrollment target is 1,884 participants. The study started on 2023-01-10. Estimated completion is 2036-01.
What conditions does trial NCT05158894 study?
This clinical trial studies the following conditions: Migraine.
Who is sponsoring clinical trial NCT05158894?
This trial is sponsored by AbbVie, which has 526 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05158894 being conducted?
This trial has 2 study locations across North Carolina, Ontario. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Migraine
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT05158894's enrollment target sits among peer trials
1,884 5th of 102 higher than 98 of 102 other Migraine trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Migraine trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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