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

Study Overview
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Brief Summary
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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.

Official Title
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ProspeCtive Observational Real-world Study of uBRogepant and Atogepant in Israel (COBRA)

Conditions
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Migraine

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Ubrogepant<br>Participants will receive ubrogepant as prescribed by their physician in routine clinical practice. | |
| Atogepant<br>Participants will receive atogepant as prescribed by their physician in routine clinical practice. | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Ubrogepant (UBRO) Only: Percentage of Participants with Responder Status of Extremely Satisfied or Satisfied on a Single Item 7-Point Scale | The single item 7-point scale asks the question Overall, how satisfied are you with Ubrelvy for treatment of your migraine? to assess change in satisfaction of migraine treatment where 0 = extremely satisfied and 6 = extremely dissatisfied. | Baseline to Day 90 | 
| Atogepant (ATO) Only: Percentage of Participants with Responder Status of Extremely Satisfied or Satisfied on a Single Item 7-Point Scale | The single item 7-point scale asks the question Overall, how satisfied are you with Qulipta for treatment of your migraine? to assess change in satisfaction of migraine treatment where 0 = extremely satisfied, 1 = satisfied and 6 = extremely dissatisfied. | Baseline to Day 90 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Ubrogepant, Ubrelvy, Atogepant, Qulipta