Study to Assess Adverse Events When Ubrogepant Tablets in Combination With Atogepant Tablets Are Used to Treat Adult Participants With Migraine

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 assess the safety and efficacy of the combination use of ubrogepant for the acute treatment of migraine headache in participants taking atogepant once daily for preventive treatment of migraine. Ubrogepant is an approved drug for the acute treatment of migraine. Atogepant is an approved drug for the preventive treatment of EM. Approximately 235 adult participants with EM will be enrolled in approximately 45 sites in the United States. Participants will receive oral atogepant tablets once daily (QD) for 12 weeks followed by continued atogepant treatment with ubrogepant tablets taken as needed for the next 12 weeks. There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic. The effect of the treatment will be checked by medical assessments, blood tests, checking for side effects and completing questionnaires.

Official Title
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A Phase 4, Multicenter, Open-Label Study to Evaluate the Safety, Tolerability, and Efficacy of the Concomitant Use of Ubrogepant for the Acute Treatment of Migraine in Subjects Taking Atogepant for the Preventive Treatment of Episodic Migraine

Conditions
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Episodic Migraine

Intervention / Treatment
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* Drug: Atogepant
* Drug: Ubrogepant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least 1-year history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD)-3, 2018. History of 4 to 14 migraine days per month on average in the 3 months prior to Screening (Visit 1) in the investigator's judgment. Exclusion Criteria: - Clinically significant hematologic, endocrine, cardiovascular, cerebrovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 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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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atogepant + Ubrogepant<br>Participants will receive atogepant for 12 weeks followed by atogepant + ubrogepant for 12 weeks. | Drug: Atogepant<br>* Oral Tablet<br>* Other names: QULIPTA;Drug: Ubrogepant<br>* Oral Tablet<br>* Other names: UBRELVY;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Participants With Adverse Events (AEs) | An adverse event (AE) is any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product and which does not necessarily have a causal relationship with this treatment. An AE can therefore be any unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medicinal (investigational) product, whether or not related to the medicinal (investigational) product. A TEAE is an AE that occurs or worsens after receiving investigational study drug. | Up to approximately 28 weeks | 
| Percentage of Participants With Clinically Significant Change in Laboratory Values as assessed by the Investigator | Percentage of participants with clinically significant change from baseline in clinical laboratory test results like hematology will be reported. | Up to approximately 28 weeks | 
| Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator | 12-lead ECGs will be recorded. | Up to approximately 24 weeks | 
| Percentage of Participants With Clinically Significant Change in Vital Sign Measurements as assessed by the Investigator | Percentage of participants with clinically significant change from baseline in vital signs like systolic and diastolic blood pressure will be reported. | Up to approximately 28 weeks | 
| Change from Baseline in Columbia-Suicide Severity Rating Scale (C-SSRS) | The C-SSRS is a clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation was classified on a 5-item scale: 1 (wish to be dead), 2 (nonspecific active suicidal thoughts), 3 (active suicidal ideation with any methods [not plan] without intent to act), 4 (active suicidal ideation with some intent to act, without specific plan), and 5 (active suicidal ideation with specific plan and intent). Suicidal behavior is classified on a 5-item scale: 0 (no suicidal behavior), 1 (preparatory acts or behavior), 2 (aborted attempt), 3 (interrupted attempt), and 4 (actual attempt). | Up to approximately 28 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Episodic Migraine, Ubrogepant, Atogepant, QULIPTA, UBRELVY