Study of Oral Atogepant Tablets to Assess Change in Disease Activity in Adult Japanese Participants With Episodic Migraine

Study Overview
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Brief Summary
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A migraine is a moderate to severe headache on one side of the head. A migraine attack is a headache that may be accompanied by throbbing, nausea, vomiting, sensitivity to light and sound, or other symptoms. This study will assess how safe and effective three different doses of atogepant is compared to placebo in adult Japanese participants. Change in migraine symptoms will be assessed. Atogepant (Qulipta) is an approved drug to treat adults with episodic migraine in the United States. Participants are randomly assigned to one of the 4 treatment groups called Arms to receive atogepant or matching placebo. There is 1 in a 4 chance for the participant to receive placebo. This is double-blinded study which means neither study doctor not the participant will know if the participant received atogepant or placebo. Approximately 520 adult participants with episodic migraine will be enrolled in approximately 50 sites across Japan. Participants will receive oral atogepant or matching placebo tablets once daily for 12 weeks. At 12 weeks participants assigned to atogepant dose A, dose B or dose C will continue to receive same treatment for 12 additional weeks and participants assigned to placebo will be re-randomized to receive atogepant dose A, dose B or dose C for 12 additional weeks. All participants will be followed for 30 days following last dose of study drug. 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 safety and tolerability of the treatment will be checked by medical assessments, blood tests, checking for adverse events and completing questionnaires.

Official Title
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A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled, Parallel-Group Study With An Active Treatment Extension to Evaluate the Efficacy, Safety, and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Subjects With Episodic Migraine

Conditions
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Migraine

Intervention / Treatment
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* Drug: Atogepant
* Drug: Placebo for Atogepant


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least a 1-year history of migraine (with or without aura). Less than 50 years of age at the time of migraine onset. History of 4 to 14 migraine days per month in the 3 months prior to screening. 4 to 14 migraine days in the baseline period and completed at least 20 out of 28 days at the baseline period per the eDiary. Exclusion Criteria: Difficulty with distinguishing migraine headaches from tension-type or other headaches. Clinically significant hematologic, endocrine, 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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Atogepant Dose A<br>Participants will receive atogepant dose A once daily (QD) for 24 weeks. | Drug: Atogepant<br>* Oral Tablet<br>* Other names: Qulipta;|
| Experimental: Atogepant Dose B<br>Participants will receive atogepant dose B QD for 24 weeks. | Drug: Atogepant<br>* Oral Tablet<br>* Other names: Qulipta;|
| Experimental: Atogepant Dose C<br>Participants will receive atogepant dose C QD for 24 weeks. | Drug: Atogepant<br>* Oral Tablet<br>* Other names: Qulipta;|
| Experimental: Placebo<br>Participants will receive placebo QD for 12 weeks. Participants will be re-randomized at week 12 to receive atogepant dose A, dose B or dose C QD for 12 weeks. | Drug: Atogepant<br>* Oral Tablet<br>* Other names: Qulipta;Drug: Placebo for Atogepant<br>* Oral Tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Monthly Migraine Days | A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary. | Up to 12 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in Mean Monthly Headache Days | A headache day is defined as any calendar day on which headache pain lasting 2 hours or longer occurs unless an acute headache medication was used after the start of the headache, in which case no minimum duration will be specified. | Up to Week 12 | 
| Change From Baseline in Mean Monthly Acute Medication Use Days | An acute medication use day is defined as any day on which a participant reports, per eDiary, the intake of allowed medication(s) for the acute treatment of migraine. | Up to Week 12 | 
| Percentage of Participants Achieving At Least 50% Reduction in the 3-month Average of Monthly Migraine Days | A migraine day is defined as any calendar day on which a headache occurs which meets criteria listed, as per participant eDiary. | Up to Week 12 | 
| Change From Baseline in Migraine Specific Quality of Life Questionnaire, Version 2.1 (MSQ v2.1) Role Function-Restrictive Domain Score | MSQ v2.1 is a 14-item questionnaire designed to measure health-related quality of life impairments attributed to migraine in the past 4 weeks. It is divided into three domains: Role Function Restrictive, Role Function Preventive, and Emotional Function domain. Participants respond to items using a 6-point scale ranging from none of the time to all of the time. Raw dimension scores are computed as a sum of item responses and rescaled to a 0 to 100 scale, where higher scores indicate better quality of life. | Up to Week 12 | 
| Change From Baseline in Mean Monthly Performance of Daily Activities Domain Score of the Activity Impairment in Migraine - Diary (AIM-D) | The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from Not difficult at all to I could not do it at all. Scores range from 0-100 scale, with higher scores indicating greater impact of migraine. | Up to Week 12 | 
| Change From Baseline in Mean Monthly Physical Impairment Domain Score of the AIM-D | The AIM-D is an 11-item daily diary measure that assesses the impact of migraine and is comprised of two domains that evaluate performance of daily activities (7 items) and physical impairment (4 items). Participants are asked to rate the level of difficulty experienced in the past 24 hours with performance of daily activities and physical impairment using a 6 point rating scale ranging from Not difficult at all to I could not do it at all. Scores range from 0-100 scale, with higher scores indicating greater impact of migraine. | Up to Week 12 | 

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