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

April 2, 2026 updated by: AbbVie

Evaluation of Function And Satisfaction of UbrogepanT-treated Migraine Patients in Canada (FAST): Prospective, Observational, Real-world Study

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.

Study Overview

Status

Active, not recruiting

Conditions

Study Type

Observational

Enrollment (Actual)

178

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3M 1M4
        • Calgary Headache Assessment and Management Program /ID# 271475
    • British Columbia
      • Vancouver, British Columbia, Canada, V6Z 2E8
        • Burrard Health Center /ID# 271474
      • Victoria, British Columbia, Canada, V8R 1J8
        • Royal Jubilee Hospital /ID# 271476
    • Nova Scotia
      • Halifax, Nova Scotia, Canada, B3R 1V9
        • Maritime Neurology /ID# 271867
    • Ontario
      • Kingston, Ontario, Canada, K7M 8H9
        • Neurocentre of Eastern Ontario /ID# 271865
      • London, Ontario, Canada, N6A 2C2
        • Centricity /ID# 271477
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 272031
      • Ottawa, Ontario, Canada, K1H 7X7
        • 360 Concussion Care /ID# 271972
      • Ottawa, Ontario, Canada, K2B 8E8
        • Bayshore Neurology /ID# 280213
      • Toronto, Ontario, Canada, M4N 3M5
        • Sunnybrook Health Sciences Centre /ID# 276844
    • Quebec
      • Lévis, Quebec, Canada, G6W 0M5
        • Centre de Recherche St-Louis /ID# 272843
      • Montreal, Quebec, Canada, H4A 3T2
        • Genge Partners /ID# 273302
      • Sherbrooke, Quebec, Canada, J1L 0H8
        • Diex Recherche Sherbrooke /ID# 271677

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Ubrogepant
Participants will receive Ubrogepant as prescribed by their physician in routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
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
Time Frame: Up to approximately 12 weeks
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 12, 2025

Primary Completion (Estimated)

May 1, 2026

Study Completion (Estimated)

May 1, 2026

Study Registration Dates

First Submitted

November 15, 2024

First Submitted That Met QC Criteria

November 15, 2024

First Posted (Actual)

November 18, 2024

Study Record Updates

Last Update Posted (Actual)

April 3, 2026

Last Update Submitted That Met QC Criteria

April 2, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P25-245

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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