Clinical trial NCT06692881: Study to Assess Function and Satisfaction of Oral Ubrogepant in Adult Participants After Multiple Migraine Attacks In Canada
Official title: Evaluation of Function And Satisfaction of UbrogepanT-treated Migraine Patients in Canada (FAST): Prospective, Observational, Real-world Study
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Migraine
Keywords: Migraine
ubrogepant
Ubrelvy
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2024-11-18
Enrollment: 167
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult participants receiving ubrogepant per routine clinical care for the treatment of migraine in Canada.

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.


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.

Primary outcomes:
measure: Percentage of Participants Achieving Functional Disability Scale (FDS) Score of =0, no disability, able to function normally 4 hours post-dose
timeFrame: Up to approximately 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Vancouver
country: Canada
facility: Dr May Ong INC /ID# 271474
state: British Columbia
city: Halifax
country: Canada
facility: Maritime Neurology /ID# 271867
state: Nova Scotia
city: Kingston
country: Canada
facility: Neurocentre of Eastern Ontario /ID# 271865
state: Ontario
city: London
country: Canada
facility: Centricity /ID# 271477
state: Ontario
city: Ottawa
country: Canada
facility: 360 Concussion Care /ID# 271972
state: Ontario
city: Montreal
country: Canada
facility: Genge Partners /ID# 273302
state: Quebec
city: Sherbrooke
country: Canada
facility: Diex Recherche Sherbrooke /ID# 271677
state: Quebec
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: