Long-term Extension Study to Assess Adverse Events of Oral Atogepant Tablets in Pediatric Participants (6 to 17 Years of Age) With Migraine
← catalyst calendarNCT05707949 · readout ≤ 2,081 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
650estimated
Sites
86
Countries
Belgium, Canada, Denmark +13
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 | 2023-06-05 | actual | When the study began enrolling |
| Primary completion | Apr 2032 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Apr 2032 | estimated | The whole study's end, after follow-up |
| First posted | 2023-02-01 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-08-11 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Migraine Prophylaxis
Intervention
- Drug: Atogepant — also filed as QULIPTA, AGN-241689
Primary outcomes
what the primary-completion date above is the date OFPercentage of Participants with Adverse Events (AEs)
measured Up to 56 Weeks
Percentage of Participants with Potentially Clinically Significant Lab Values
measured Up to 52 Weeks
Percentage of Participants with Potentially Clinically Significant Clinical 12-lead Electrocardiogram (ECG)
measured Up to 52 Weeks
Percentage of Participants with Potentially Clinically Significant Vital Sign Parameters
measured Up to 52 Weeks
Percentage of with Participants with Treatment-Emergent Suicidal Ideations with Intent, with or without a Plan (i.e., Type 4 or 5 on Columbia-Suicide Severity Rating Scale [C-SSRS]), or any Suicidal Behaviors
measured Up to 52 Weeks
Percentage of Participants with Change in Menstrual Cycle (Female Participants Only)
measured Up to 52 Weeks
Change from Baseline in Tanner Staging Score
measured Baseline (Week 0) through Week 52
Change from Baseline in Behavior Rating Inventory of Executive Function, 2nd Edition (BRIEF 2) questionnaire
measured Baseline (Week 0) through Week 52
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