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)

AbbVie

Status: Completed

Conditions: Migraine

Study type: Observational

Funder types: Industry

Identifiers

NCT05653986

P23-495

Details and patient eligibility

About

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.

Enrollment: 391 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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®)

Trial design

391 participants in 1 patient group

Ubrogepant + Atogepant

Description:

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