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

Recruiting

• Conditions: Migraine

• Registration Number: NCT06692881
• Lead Sponsor: AbbVie

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 available

Study Timeline

• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-15
• Study First Posted: 2024-11-18
• Study Start: 2025-02-12
• Status Verified: 2025-05
• Last Update Submitted: 2025-05-05
• Last Update Posted: 2025-05-06
• Primary Completion: 2026-01
• Study Completion: 2026-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 167

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Percentage of Participants Achieving Functional Disability Scale (FDS) Score of =0, no disability, able to function normally 4 hours post-dose	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)

Trial Locations

Locations (7)

Genge Partners /ID# 273302; 🇨🇦 Montreal, Quebec, Canada

Diex Recherche Sherbrooke /ID# 271677; 🇨🇦 Sherbrooke, Quebec, Canada

Dr May Ong INC /ID# 271474; 🇨🇦 Vancouver, British Columbia, Canada

Maritime Neurology /ID# 271867; 🇨🇦 Halifax, Nova Scotia, Canada

Neurocentre of Eastern Ontario /ID# 271865; 🇨🇦 Kingston, Ontario, Canada

Centricity /ID# 271477; 🇨🇦 London, Ontario, Canada

360 Concussion Care /ID# 271972; 🇨🇦 Ottawa, Ontario, Canada