Long-term Extension Study to Assess Safety and Tolerability of Oral Ubrogepant Tablets for the Acute Treatment of Migraine in Pediatric Participants (Ages 6-17)
← catalyst calendarNCT05127954 · readout ≤ 530 d
Sponsored by AbbVie (industry) · ABBV — their whole pipeline →.
Phase
Phase 3
Status
Enrolling by invitation
Study type
Interventional
Design
Non randomized · None · Treatment
Enrollment
1,200estimated
Sites
113
Countries
Puerto Rico, United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-01-14 | actual | When the study began enrolling |
| Primary completion | Jan 2028 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jan 2028 | estimated | The whole study's end, after follow-up |
| First posted | 2021-11-19 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-07-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Migraine
Intervention
- Drug: Ubrogepant — also filed as Ubrelvy
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants with Adverse Events (AEs)
measured up to 54 weeks
Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)
measured Up to 54 Weeks
Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters
measured Up to 54 Weeks
Percentage of Participants with Potentially Clinically Significant lab values
measured Up to 54 Weeks
Percentage of with Participants with Suicidal Ideation or Suicidal Behavior
measured Up to 54 Weeks
Percentage of Participants with Change in Menstrual Cycle
measured Up to 54 Weeks
Change from baseline in Tanner staging score
measured Up to 54 Weeks
Change From baseline in Behavior Rating Inventory of Executive Function (BRIEF 2) questionnaire
measured up to 54 weeks
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