Clinical trial NCT05653986: An Observational Study to Assess Change in Disease Activity When Ubrogepant Tablets Are Combined With Atogepant Tablets to Treat Migraine in Adult Participants
Official title: A Prospective, Observational Diary Study to Evaluate the Real-World Effectiveness of the Acute Treatment of Migraine With Ubrogepant, When Used in Combination With Atogepant for Prevention
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Migraine
Keywords: Migraine
Ubrogepant
Ubrelvy
Atogepant
Qulipta
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2022-12-16
Enrollment: 391
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 with migraine using Migraine Buddy mobile application and prescribed Ubrogepant and Atogepant by their physician

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 how effective the combination use of ubrogepant and atogepant is in treating adult participants with migraine. Change in migraine activity will be assessed.

Urogepant (Ubrelvy) and Atogepant (Qulipta) are approved drugs for treatment of migraine in adults in the US. Approximately 432 adult participants who are prescribed Ubrogepant and atogepant by their doctors will be enrolled in this study in the United States.

Participants will receive ubrogepant oral tablets and atogepant oral tablets as prescribed by their physician. Participants will be followed for 30 days.

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:

* Reports meeting migraine diagnostic criteria consistent with International Classification of Headache Disorders (ICHD) (i.e., they report symptoms accompanying their headaches that meet migraine criteria22 at screening).
* Currently using ubrogepant for acute treatment of migraine.
* Experienced at least 3 migraine attacks in the last 30 days.
* Currently taking atogepant for preventive treatment of migraine and has been taking atogepant, at the same dose, for at least 30 days.

Exclusion Criteria:

* Report currently taking Rimegepant (Nurtec®) for migraine treatment (acute or preventive).
* Report currently taking any of the anti-CGRP mAbs for preventive treatment of migraine:

  * Erenumab (Aimovig®)
  * Galcanezumab (Emgality®)
  * Fremanezumab (Ajovy®)
  * Eptinezumab (Vyepti®)

Primary outcomes:
measure: Percentage of Participants Achieving Meaningful Pain Relief
timeFrame: Up to approximately 30 days
measure: Percentage of Participants Who Return to Normal Function
timeFrame: Up to approximately 30 days
Secondary outcomes:
Other outcomes:
Locations:
city: Bronx
country: United States
facility: Montefiore/Albert Einstein /ID# 252243
state: New York
Study officials:
affiliation: AbbVie
name: ABBVIE INC.
role: STUDY_DIRECTOR
References: