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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

NOT_YET_RECRUITING

Total Enrollment

189 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-12-17

Study Completion Date

2027-03-31

Brief Summary

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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.

Detailed Description

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Conditions

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Migraine

Keywords

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Migraine Ubrogepant UBRELVY

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ubrogepant

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

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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ABBVIE INC.

Role: STUDY_DIRECTOR

AbbVie

Central Contacts

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Krystal Spenta

Role: CONTACT

Phone: 844-663-3742

Email: [email protected]

Other Identifiers

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P25-590

Identifier Type: -

Identifier Source: org_study_id