An Observational Study to Assess Change in Disease Activity When Ubrogepant Tablets Are Combined … (NCT05653986) | Clinical Trial Compass
CompletedNot Applicable
An Observational Study to Assess Change in Disease Activity When Ubrogepant Tablets Are Combined With Atogepant Tablets to Treat Migraine in Adult Participants
United States391 participantsStarted 2022-12-18
Plain-language 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.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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®)
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Percentage of Participants Achieving Meaningful Pain Relief
Timeframe: Up to approximately 30 days
2
Percentage of Participants Who Return to Normal Function