Study to Assess the Real-World Effectiveness of Ubrogepant in Adult Participants When Treating During the Prodrome Phase of Migraine Attacks
PHASES
PHASES: Prodrome in tHe reAl World: aSsESsing Ubrogepant Acute Use
1 other identifier
observational
189
1 country
3
Brief Summary
Migraine is a neurological disease characterized by moderate or severe headaches, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will assess changes in migraine attack severity for adult participants treating with oral ubrogepant across migraine attacks. Ubrogepant is a drug that is approved for the acute treatment of migraine in adults. Approximately 189 participants will be enrolled in approximately 15 sites across the US. Participants will receive ubrogepant as prescribed by their physician according to their routine clinical practice and local label. Participants will be followed for up to 13 weeks. There is expected to be no additional burden for participants in this trial. Participants will attend regular visits during the study at a hospital or clinic according to their routine clinical practice.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for all trials
Started Jan 2026
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 16, 2025
CompletedFirst Posted
Study publicly available on registry
December 30, 2025
CompletedStudy Start
First participant enrolled
January 27, 2026
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2027
ExpectedStudy Completion
Last participant's last visit for all outcomes
March 1, 2027
February 10, 2026
February 1, 2026
1.1 years
December 16, 2025
February 9, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Percentage of Participants with Absence of moderate to severe headache over 24 hours post-dose during prodrome.
Prodrome is often the earliest phase of migraine attack and consists of various symptoms including sensitivity to light, fatigue, neck pain, sensitivity to sound, dizziness and difficulty thinking/concentrating.
Up to approximately 13 weeks
Study Arms (1)
Ubrogepant
Participants will receive Ubrogepant as prescribed by their physician according to local label.
Eligibility Criteria
Adult participants receiving ubrogepant per routine clinical care for the treatment of migraine in the US.
You may qualify if:
- History of 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1
- a. Participants with a diagnosis of chronic migraine who report having 4 to 10 migraine days per month with moderate to severe headache pain in each month of the 3 months prior to Visit 1 due to concomitant preventive treatment are allowed in the study
- Participant is currently prescribed ubrogepant and has been using ubrogepant for at least 3 months for the acute treatment of migraine in adults, according to the US Food and Drug Administration (FDA)-approved indication
- Adult participants with current clinical diagnosis of migraine or chronic migraine according to International Classification of Headache Disorders (ICHD)-3
You may not qualify if:
- Currently participating in a concurrent clinical or non-interventional study.
- Concomitant use with a strong Cytochrome P450 3A4 (CYP3A4 ) inhibitor.
- Current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia, status migrainosus or painful cranial neuropathy as defined by ICHD-3
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- AbbVielead
Study Sites (3)
Neurology and Pain Specialty Center /ID# 278508
Aliso Viejo, California, 92656, United States
Chicago Headache Center & Research Inst /ID# 272345
Naperville, Illinois, 60563, United States
Tri City Research Center, LLC /ID# 278800
Grand Island, Nebraska, 68803, United States
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
ABBVIE INC.
AbbVie
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 16, 2025
First Posted
December 30, 2025
Study Start
January 27, 2026
Primary Completion (Estimated)
March 1, 2027
Study Completion (Estimated)
March 1, 2027
Last Updated
February 10, 2026
Record last verified: 2026-02