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

Last updated: August 16, 2024
Sponsor: AbbVie
Overall Status: Completed

Phase

N/A

Condition

Pain (Pediatric)

Headaches

Pain

Treatment

N/A

Clinical Study ID

NCT05653986
P23-495
  • Ages > 18
  • All Genders

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Reports meeting migraine diagnostic criteria consistent with InternationalClassification of Headache Disorders (ICHD) (i.e., they report symptoms accompanyingtheir 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 takingatogepant, at the same dose, for at least 30 days.

Exclusion

Exclusion Criteria:

  • Report currently taking Rimegepant (Nurtec®) for migraine treatment (acute orpreventive).

  • Report currently taking any of the anti-CGRP mAbs for preventive treatment ofmigraine:

  • Erenumab (Aimovig®)

  • Galcanezumab (Emgality®)

  • Fremanezumab (Ajovy®)

  • Eptinezumab (Vyepti®)

Study Design

Total Participants: 391
Study Start date:
December 18, 2022
Estimated Completion Date:
August 05, 2024

Connect with a study center

  • Montefiore/Albert Einstein

    Bronx, New York 10461
    United States

    Active - Recruiting

  • Montefiore/Albert Einstein /ID# 252243

    Bronx, New York 10461
    United States

    Site Not Available

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