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

NCT06692881 | Recruiting

• 1 other identifier: P25-245
• Study Type: observational
• Target: 167
• Locations: 1 country
• Sites: 13

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.

Conditions

Migraine

Keywords

Migraine; ubrogepant; Ubrelvy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Ubrogepant

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie: lead

Study Sites (13)

Calgary Headache Assessment and Management Program /ID# 271475

Calgary, Alberta, T3M 1M4, Canada

ACTIVE NOT RECRUITING

Burrard Health Center /ID# 271474

Vancouver, British Columbia, V6Z 2E8, Canada

RECRUITING

Royal Jubilee Hospital /ID# 271476

Victoria, British Columbia, V8R 1J8, Canada

RECRUITING

Maritime Neurology /ID# 271867

Halifax, Nova Scotia, B3R 1V9, Canada

RECRUITING

Neurocentre of Eastern Ontario /ID# 271865

Kingston, Ontario, K7M 8H9, Canada

RECRUITING

Centricity /ID# 271477

London, Ontario, N6A 2C2, Canada

RECRUITING

London Health Sciences Centre - Victoria Hospital & Children's Hospital /ID# 272031

London, Ontario, N6A 5W9, Canada

RECRUITING

360 Concussion Care /ID# 271972

Ottawa, Ontario, K1H 7X7, Canada

RECRUITING

Bayshore Neurology /ID# 280213

Ottawa, Ontario, K2B 8E8, Canada

RECRUITING

Sunnybrook Health Sciences Centre /ID# 276844

Toronto, Ontario, M4N 3M5, Canada

RECRUITING

Centre de Recherche St-Louis /ID# 272843

Lévis, Quebec, G6W 0M5, Canada

RECRUITING

Genge Partners /ID# 273302

Montreal, Quebec, H4A 3T2, Canada

RECRUITING

Diex Recherche Sherbrooke /ID# 271677

Sherbrooke, Quebec, J1L 0H8, Canada

RECRUITING

Related Links

• Related Info

MeSH Terms

Conditions

Migraine Disorders

Condition Hierarchy (Ancestors)

Headache Disorders, Primary; Headache Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases

Study Officials

• ABBVIE INC.

  AbbVie

  STUDY DIRECTOR

Central Study Contacts

Kelly Boyd

CONTACT

5148327258; kelly.boyd@abbvie.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 15, 2024
• First Posted: November 18, 2024
• Study Start: February 12, 2025
• Primary Completion: May 1, 2026
• Study Completion: May 1, 2026
• Last Updated: March 12, 2026

Record last verified: 2026-03

Locations

CA (13)