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

Not yet 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.
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Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design

Study Timeline

• Status Verified: 2024-11
• Study First Submitted: 2024-11-15
• Study First Submitted QC: 2024-11-15
• Last Update Submitted: 2024-11-15
• Study First Posted: 2024-11-18
• Last Update Posted: 2024-11-18
• Study Start: 2024-11-30
• Primary Completion: 2026-01-31
• Study Completion: 2026-01-31

Recruitment & Eligibility

• Status: NOT_YET_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.

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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.

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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)