Study to Assess Function and Satisfaction of Oral Ubrogep... | NCT06692881

Studies
Study to Assess Function and Satisfaction of Oral Ubrogepant in Adult Participants After Multiple Migraine Attacks In Canada

NCT06692881

Sponsor

AbbVie

Status

Completed

Last Update Posted

Jun 29, 2026Actual

Enrollment

178Actual

Phase

Not provided

Conditions

Migraine

Interventions

Not provided

Countries

Canada

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

Jun 2026

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 12, 2025Actual

Primary Completion Date

Jun 1, 2026Actual

Completion Date

Jun 1, 2026Actual

First Submitted Date

Nov 15, 2024

First Submission Date that Met QC Criteria

Nov 15, 2024

First Posted Date

Nov 18, 2024Actual

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

Jun 26, 2026

Last Update Posted Date

Jun 29, 2026Actual

Description Module

Brief Summary

Migraine is a neurological disease characterized by moderate or severe headache, associated with nausea, vomiting, and/or sensitivity to light and sound. This study will evaluate function and satisfaction with oral ubrogepant in treating adult participants after multiple migraine attacks.

Ubrogepant is a drug approved for the acute treatment of migraine in adults. Approximately 167 participants will be enrolled in approximately 10-15 sites across Canada.

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 12 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

178Actual

Label	Type	Description	Intervention Names
Ubrogepant		Participants will receive Ubrogepant as prescribed by their physician in routine clinical practice.

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Percentage of Participants Achieving Functional Disability Scale (FDS) Score of =0, no disability, able to function normally 4 hours post-dose	Functional Disability Scale (FDS) is a Patient-Reported Outcome (PRO) assessing the ability of a participant to perform daily activities, rated on a 4-point scale (0=no disability, able to function normally; to 3=severely impaired, cannot do all or most things, bed rest may be necessary)	Up to approximately 12 weeks

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Participants able to give voluntary informed consent before starting any study-related assessments or procedures (to be obtained/documented as per local regulations).
Adults (≥18 years of age) at time of informed consent.
Participants with at least 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3 (2018).
Participants with history of experiencing at least 3 migraine attacks per month with moderate to severe symptoms
Participants prescribed ubrogepant by investigator for the acute treatment of migraine according to local product label, independent of and prior to study participation
Participants willing and able to comply with the requirements of the study.
Participants with access to an electronic device (mobile phone, tablet, laptop, etc.) with internet access.

Exclusion Criteria:

Participants previously exposed to a ubrogepant or rimegepant as routine therapy or through a clinical trial.
Participants with history of known contraindications to ubrogepant as per local labeling.
Participants Pregnant or planning to be pregnant or of childbearing potential not using contraception
Participants enrolled in any interventional studies that may include investigational compounds for migraine or non-AbbVie observational studies.
History or current evidence of any condition that might interfere with their ability to comply with the study requirements, in the opinion of the investigator.

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 Canada.

Sampling Method

Non-Probability Sample

Facility	Status	City	State	ZIP	Country	Contacts
Calgary Headache Assessment and Management Program /ID# 271475		Calgary	Alberta	T3M 1M4	Canada
Burrard Health Center /ID# 271474

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