An Observational Study to Assess Change in Disease Activity When Ubrogepant Tablets Are Combined With Atogepant Tablets to Treat Migraine in Adult Participants

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

391 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-12-18

Study Completion Date

2024-08-05

Brief Summary

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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.

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Detailed Description

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Conditions

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Migraine

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Ubrogepant + Atogepant

Participants will receive ubrogepant in combination with atogepant as prescribed by their physician in routine clinical practice.

No interventions assigned to this group

Eligibility Criteria

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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®)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No