Study of Oral Atogepant When Added to OnabotulinumtoxinA (BOTOX) to Assess Adverse Events and Change in Disease Activity in Adult Participants With Chronic Migraine
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Phase
Phase 3
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
75actual
Sites
29
Country
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 | 2022-03-22 | actual | When the study began enrolling |
| Primary completion | 2025-05-02 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-05-02 | actual | The whole study's end, after follow-up |
| First posted | 2022-01-31 | actual | When this record first appeared on the registry |
| Results posted | 2026-06-16 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-06-16 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Chronic Migraine
Intervention
- Drug: Atogepant — also filed as QULIPTA
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Adverse Events (AEs)
measured From first dose of study drug until 4 weeks following last dose of study drug (up to 28 weeks)
Percentage of Participants With Potentially Clinically Significant (PCS) Laboratory Values (Chemistry, Hematology, Urinalysis) as Assessed by the Investigator
measured From first dose of study drug until last dose of study drug (24 weeks)
Percentage of Participants With Potentially Clinically Significant (PCS) Vital Sign Measurements as Assessed by the Investigator
measured From first dose of study drug until last dose of study drug (24 weeks)
Percentage of Participants With Most Severe Suicidal Ideation and Suicidal Behavior as Assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) During the Open-Label Treatment Period
measured From first dose of study drug until last dose of study drug (24 weeks)
Percentage of Participants With Potentially Clinically Significant (PCS) Electrocardiograms (ECGs) Findings as Assessed by the Investigator
measured From first dose of study drug until last dose of study drug (24 weeks)
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-08-22 · 4.4 MB · Prot_000.pdf
Statistical Analysis Planposted 2025-05-08 · 435 KB · SAP_001.pdf
Publications
- PMID 41944477 — linked by the registry
Linked on the registry record. A “linked by the registry” entry is NLM's own automated PubMed match, not a claim by the sponsor that the paper reports this study.
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