MigraineCOURAGE IINCT05653986
An Observational Study to Assess Change in Disease Activity When Ubrogepant Tablets Are Combined With Atogepant Tablets to Treat Migraine in Adult Participants
An observational study of Migraine, run by AbbVie at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Migraine
- How many people
- 391 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Dec 2022to 5 Aug 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Adult participants with migraine using Migraine Buddy mobile application and prescribed Ubrogepant and Atogepant by their physician
Who may be able to join
- 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.
Who cannot join
- 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®)
Trial locations and contacts
1 site in 1 country.
United States1 site
Montefiore/Albert Einstein /ID# 252243
The Bronx, New York, 10461
About this study
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
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.
Read more
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.
- Conditions
- Migraine
- Keywords
- Migraine, Ubrogepant, Ubrelvy, Atogepant, Qulipta
- Medical subject headings
- Migraine Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Ubrogepant + Atogepant | Participants will receive ubrogepant in combination with atogepant as prescribed by their physician in routine clinical practice. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants Achieving Meaningful Pain Relief
Meaningful relief occurs when the level of headache pain has been reduced to a degree that is meaningful to the participant; this can, but does not necessarily, occur prior to pain freedom. Participants will provide responses for ubrogepant-treated migraine attacks about the time to achieve meaningful relief of headache pain. This will result in a binary responder definition coded as "yes" for those achieving meaningful pain relief or "no" for those not satisfying that definition.
Measured: Up to approximately 30 days
Percentage of Participants Who Return to Normal Function
Participants will also rate the ability to perform daily activities at the point when ubrogepant was taken using the Functional Disability Scale. The responses include "No disability (able to function normally)," "Mildly impaired (can still do everything but with difficulty)," "Moderately impaired (unable to do some things)," "Severely impaired (unable to do all or most things, bed rest may be necessary)." This will result in a binary responder definition coded as "yes" for those achieving return to normal function or "no" for those not satisfying that definition.
Measured: Up to approximately 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2022
- Study start18 Dec 2022
- Primary completion5 Aug 2024
- Study completion5 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for MigraineStudies of the same condition, open and under way.
- More trials run by AbbVieThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 391 participants (actual)
Sponsor and investigators
- Lead sponsor
- AbbVie
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- ABBVIE INC., Study director, AbbVie
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05653986
- Sponsor's protocol ID
- P23-495
- Acronym
- COURAGE II
- Status last verified
- Jun 2026
- First submitted
- 14 Dec 2022
- Last updated
- 3 Jun 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05653986
- Acronym / sponsor ID
- COURAGE II / P23-495
- Conditions
- Migraine
- Keywords
- Migraine, Ubrogepant, Ubrelvy, Atogepant, Qulipta
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 391 participants (actual)
- Lead sponsor
- AbbVieIndustry (pharma, biotech, devices)
- Study start
- 18 Dec 2022 (actual)
- Primary completion
- 5 Aug 2024 (actual)
- Study completion
- 5 Aug 2024 (actual)
- First posted
- 16 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Ubrogepant + Atogepant | – | –Participants will receive ubrogepant in combination with atogepant as prescribed by their physician in routine clinical practice. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with migraine using Migraine Buddy mobile application and prescribed Ubrogepant and Atogepant by their physician
Key inclusion criteria (4 listed)
- 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.
Key exclusion criteria (6 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Percentage of Participants Achieving Meaningful Pain Relief
Time frame: Up to approximately 30 days
Meaningful relief occurs when the level of headache pain has been reduced to a degree that is meaningful to the participant; this can, but does not necessarily, occur prior to pain freedom. Participants will provide responses for ubrogepant-treated migraine attacks about the time to achieve meaningful relief of headache pain. This will result in a binary responder definition coded as "yes" for those achieving meaningful pain relief or "no" for those not satisfying that definition.
Percentage of Participants Who Return to Normal Function
Time frame: Up to approximately 30 days
Participants will also rate the ability to perform daily activities at the point when ubrogepant was taken using the Functional Disability Scale. The responses include "No disability (able to function normally)," "Mildly impaired (can still do everything but with difficulty)," "Moderately impaired (unable to do some things)," "Severely impaired (unable to do all or most things, bed rest may be necessary)." This will result in a binary responder definition coded as "yes" for those achieving return to normal function or "no" for those not satisfying that definition.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Jun 2026.
- Clinical Study Report SynopsisLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
ABBVIE INC. study director
AbbVie
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Migraine, run by AbbVie at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 3 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage of Participants Achieving Meaningful Pain Relief (time frame: Up to approximately 30 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Jun 2026.