CClinicalTrials.gg
CompletedNCT05653986COURAGE IIUpdated Jun 3, 2026

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 in Migraine, sponsored by AbbVie. Completed at 1 site in United States. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-06-03.

Sponsored by AbbVie · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
391
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Migraine

Browse trials for

Keywords

  • Migraine
  • Ubrogepant
  • Ubrelvy
  • Atogepant
  • Qulipta
03

In context

Migraine Disorders

1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.

This study's enrollment of 391 is above the median of 130 across 299 observational studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

AbbVie is the lead sponsor of 953 studies on the registry; 136 are open to participants now.

Of its 350 completed or terminated interventional studies of FDA-regulated products, 210 (60%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No
Sampling method
Non-probability sample

Study population

Adult participants with migraine using Migraine Buddy mobile application and prescribed Ubrogepant and Atogepant by their physician

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

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®)
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
391 participants (actual)

Groups and cohorts

  • Ubrogepant + Atogepant

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

06

What researchers measure

Primary outcomes

  1. 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.

    Time frame: Up to approximately 30 days

  2. 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.

    Time frame: Up to approximately 30 days

07

Study locations

1 site
  • Montefiore/Albert Einstein /ID# 252243
    The Bronx, New York 10461, United States
08

References and documents

Individual participant data

Plan to share: Undecided

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Jun 3, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05653986
Lead sponsor
AbbVie
Responsible party
Sponsor
First posted
Dec 16, 2022
Start date
Dec 18, 2022
Primary completion
Aug 5, 2024
Completion
Aug 5, 2024
Last update
Jun 3, 2026

Study contacts

ABBVIE INC.
study director · AbbVie

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jun 2026. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Other studies from this sponsor

AbbVie

Start the discussion