Recruiting

Ubrogepant

Sponsor:

AbbVie

Code:

NCT07310290

Conditions

Migraine

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Study Details

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.

Conditions

Migraine

Study ID

NCT07310290

Start date

Jan 27, 2026

Status verified date

Feb, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • 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 Criteria:

  • 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

Study Design

Enrollment

189 participants

Anticipated

Interventions and Outcome Measures

Arms

Ubrogepant

Participants will receive Ubrogepant as prescribed by their physician according to local label.

Primary outcome measure

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

Central Contacts and Locations

Central contacts

Krystal Spenta

844-663-3742krystal.spenta@abbvie.com

Locations

Neurology and Pain Specialty Center /ID# 278508

Recruiting

Aliso Viejo, California, United States, 92656

Chicago Headache Center & Research Inst /ID# 272345

Recruiting

Naperville, Illinois, United States, 60563

Tri City Research Center, LLC /ID# 278800

Recruiting

Grand Island, Nebraska, United States, 68803

More Information

Sponsor

AbbVie

Last update posted

Feb 10, 2026

Last verified

Feb, 2026

Keywords

  • Migraine
  • Ubrogepant
  • UBRELVY

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by AbbVie on 2026-02-10.