Evaluating the effectiveness of ubrogepant for migraine relief in adults in Canada

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

This study is testing how well ubrogepant works for relieving migraine symptoms in adults across Canada who have frequent migraine attacks.

Quick facts

• Study type: Observational
• Enrollment: 167 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: AbbVie (Industry-sponsored)
• Locations: 7 sites (Vancouver, British Columbia and 6 other locations)
• Trial ID: NCT06692881 on ClinicalTrials.gov

What this trial studies

This observational study assesses the function and satisfaction of oral ubrogepant in adults who experience multiple migraine attacks. Approximately 167 participants will be enrolled across 10-15 sites in Canada, receiving ubrogepant as prescribed by their physicians. Participants will be monitored for up to 12 weeks, attending regular visits at their local clinics or hospitals without any additional burden. The study aims to gather real-world data on the effectiveness of ubrogepant in treating acute migraine symptoms.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 and older with a history of migraines, experiencing at least three moderate to severe attacks per month.

Not a fit: Patients who have previously used ubrogepant or rimegepant as part of their treatment may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could provide valuable insights into the effectiveness of ubrogepant for managing migraine symptoms in adults.

How similar studies have performed: While ubrogepant has been approved for migraine treatment, this specific observational approach to assess patient satisfaction and function is relatively novel.

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.

Where this trial is running

Vancouver, British Columbia and 6 other locations

• Dr May Ong INC /ID# 271474 — Vancouver, British Columbia, Canada (Recruiting)
• Maritime Neurology /ID# 271867 — Halifax, Nova Scotia, Canada (Recruiting)
• Neurocentre of Eastern Ontario /ID# 271865 — Kingston, Ontario, Canada (Recruiting)
• Centricity /ID# 271477 — London, Ontario, Canada (Recruiting)
• 360 Concussion Care /ID# 271972 — Ottawa, Ontario, Canada (Recruiting)
• Genge Partners /ID# 273302 — Montreal, Quebec, Canada (Recruiting)
• Diex Recherche Sherbrooke /ID# 271677 — Sherbrooke, Quebec, Canada (Recruiting)

Study contacts

• Study coordinator: Kelly Boyd

Conditions Migraine; ubrogepant; Ubrelvy