Study to Assess the Real-World Effectiveness of Ubrogepan... | NCT07310290

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

NCT07310290

Sponsor

AbbVie

Status

Recruiting

Last Update Posted

Feb 10, 2026Actual

Enrollment

189Estimated

Phase

Not provided

Conditions

Migraine

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Feb 2026

Overall Recruitment Status or Expanded Access Status

Recruiting

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 27, 2026Actual

Primary Completion Date

Mar 2027Estimated

Completion Date

Mar 2027Estimated

First Submitted Date

Dec 16, 2025

First Submission Date that Met QC Criteria

Dec 16, 2025

First Posted Date

Dec 30, 2025Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Feb 9, 2026

Last Update Posted Date

Feb 10, 2026Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

189Estimated

Label	Type	Description	Intervention Names
Ubrogepant		Participants will receive Ubrogepant as prescribed by their physician according to local label.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Adult participants receiving ubrogepant per routine clinical care for the treatment of migraine in the US.

Sampling Method

Non-Probability Sample

Name	Role	Phone	Extension	Email
Krystal Spenta	Contact	844-663-3742		krystal.spenta@abbvie.com

Name	Affiliation	Role
ABBVIE INC.	AbbVie	Study Director

Facility	Status	City	State	ZIP	Country	Contacts
Neurology and Pain Specialty Center /ID# 278508	Recruiting	Aliso Viejo	California	92656	United States

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D051270	Headache Disorders, Primary
D020773	Headache Disorders
D001927	Brain Diseases
D002493	Central Nervous System Diseases