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

October 2, 2023 updated by: AbbVie

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.

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 Overview

Status

Recruiting

Conditions

Study Type

Observational

Enrollment (Estimated)

432

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • United States
    • New York
      • Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore/Albert Einstein /ID# 252243

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

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

Description

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®)

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Ubrogepant + Atogepant
Participants will receive ubrogepant in combination with atogepant as prescribed by their physician in routine clinical practice.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Up to approximately 30 days
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.
Up to approximately 30 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

AbbVie

Investigators

  • Study Director: ABBVIE INC., AbbVie

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 18, 2022

Primary Completion (Estimated)

April 30, 2024

Study Completion (Estimated)

April 30, 2024

Study Registration Dates

First Submitted

December 14, 2022

First Submitted That Met QC Criteria

December 14, 2022

First Posted (Actual)

December 16, 2022

Study Record Updates

Last Update Posted (Actual)

October 3, 2023

Last Update Submitted That Met QC Criteria

October 2, 2023

Last Verified

October 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P23-495

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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