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An Observational Study to Assess Ubrogepant Tablets and Atogepant Tablets to Treat Migraine in Adult Participants (COBRA)

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AbbVie

Status

Enrolling

Conditions

Migraine

Study type

Observational

Funder types

Industry

Identifiers

NCT05827887
P24-078

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 evaluate how effective the use of ubrogepant and atogepant is in treating adult participants with migraine.

Urogepant (Ubrelvy) and Atogepant (Qulipta) are approved drugs for treatment of migraine in adults in the US. Approximately 200 adult participants who are prescribed Ubrogepant or atogepant by their doctors will be enrolled in this study in Israel.

Participants will receive ubrogepant oral tablets or atogepant oral tablets as prescribed by their physician. Participants will be followed for 90 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

200 estimated patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Confirmed diagnosis of migraine according to the ICHD-3 upon judgement of the treating physician
  • The patients should be naive to the designated treatment
  • Ability to fill an e-diary app

Exclusion criteria

  • Patients who cannot be treated with UBRO or ATO according to the applicable approved label
  • Patients participating in a concurrent clinical interventional study or within the last 30 days
  • Patients who were previously treated with rimegepant will be excluded from the study

Trial design

200 participants in 2 patient groups

Ubrogepant
Description:
Participants will receive ubrogepant as prescribed by their physician in routine clinical practice.
Atogepant
Description:
Participants will receive atogepant as prescribed by their physician in routine clinical practice.

Trial contacts and locations

12

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Central trial contact

Tal Nevo

Data sourced from clinicaltrials.gov

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