Ubrogepant for Migraine Treatment During Prodrome

This study is looking at how well ubrogepant works for adults who treat their migraine attacks during the prodrome phase (the time before a migraine headache starts). Ubrogepant is an approved medication for acute migraine treatment. Researchers want to see if taking ubrogepant at this early stage helps prevent moderate to severe headaches for 24 hours after treatment. You might be able to join if you are an adult with 4 to 10 migraine days per month, with moderate to severe headache pain, for the past three months. This is an observational study, meaning you would take ubrogepant as prescribed by your doctor. About 189 people will participate across the US. The study's current status is unclear.

Study design
This is an observational study involving approximately 189 adult participants. It is not specified if it is blinded or randomized.
What's involved
You would take ubrogepant as prescribed by your physician according to your routine clinical practice. There is expected to be no additional burden for participants.
Compensation
Not stated in the trial record.
Follow-up
Participants will be followed for up to approximately 13 weeks.

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NCT07310290

Study to Assess the Real-World Effectiveness of Ubrogepant in Adult Participants When Treating During the Prodrome Phase of Migraine Attacks

Recruiting
Not specifiedAges 18+Observational
AbbVie
~189 participants
Updated 2026-02-10 on ClinicalTrials.gov

At a glance

Recruiting sites
3 of 3 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Percentage of Participants with Absence of moderate to severe headache over 24 hours post-dose during prodrome.
Measured over Up to approximately 13 weeks
Migraine
3 sites across 3 states
California1
Illinois1
Nebraska1
  • ABBVIE INC. · STUDY_DIRECTOR · AbbVie

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Eligibility criteria

Inclusion

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

Exclusion

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
  • Percentage of Participants with Absence of moderate to severe headache over 24 hours post-dose during prodrome.Up to approximately 13 weeks

    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.