A Study Evaluating Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

Study Overview
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Brief Summary
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This study will evaluate the long-term safety, efficacy and tolerability of atogepant 60 mg daily for the prevention of migraine in Japanese participants with chronic or episodic migraine.

Official Title
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A Phase 3, Multicenter, Open-Label 52-Week Extension Study to Evaluate the Long-Term Safety and Tolerability of Oral Atogepant for the Prevention of Migraine in Japanese Participants With Chronic or Episodic Migraine

Conditions
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Chronic Migraine, Episodic Migraine

Intervention / Treatment
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* Drug: Atogepant 60 mg


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 3101-303-002 Completers: Eligible participants who completed Visit 7, and Visit 8 if applicable, of the Study 3101-303-002 without significant protocol deviations and who did not experience an adverse event (AE) that, in the investigator's opinion, may indicate an unacceptable safety risk. De Novo EM Participants: Age of the participant at the time of migraine onset < 50 years. At least a 1-year history of migraine with or without aura consistent with a diagnosis according to the ICHD-3, 2018. History of 4 to 14 migraine days per month on average in the 3 months prior to Visit 1 in the investigator's judgment. 4 to 14 migraine days in the 28-day baseline period per eDiary. Completed at least 20 out of 28 days in the eDiary during baseline period and is able to read, understand, and complete the study questionnaires and eDiary per investigator's judgment. Exclusion Criteria: Requirement for any medication, diet, or nonpharmacological treatment that is on the list of prohibited concomitant medications or treatments that cannot be discontinued or switched to an allowable alternative medication or treatment. Participants with an ECG indicating clinically significant abnormalities at Visit -1 (De Novo Episodic Migraine Participants) or Visit 1 (3103-303-002 Completers). Hypertension as defined by sitting systolic BP > 160 mm Hg or sitting diastolic BP > 100 mm Hg at Visit 1. Significant risk of self-harm based on clinical interview and responses on the (Columbia-Suicide Severity Rating Scale [C-SSRS]), or of harm to others in the opinion of the investigator. Any clinically significant hematologic, endocrine, cardiovascular, pulmonary, renal, hepatic, gastrointestinal, or neurologic disease. De Novo EM Participants only: Difficulty distinguishing migraine headaches from tension-type or other headaches. Has a history of migraine accompanied by diplopia or decreased level of consciousness or retinal migraine as defined by ICHD-3, 2018. Has a current diagnosis of chronic migraine, new persistent daily headache, trigeminal autonomic cephalgia (eg, cluster headache), or painful cranial neuropathy as defined by ICHD-3, 2018. Has >= 15 headache days per month on average across the 3 months prior to Visit 1 in the investigator's judgment. Has >= 15 headache days in the 28-day baseline period per eDiary. Usage of opioids or barbiturates > 2 days/month, triptans or ergots >= 10 days/month, or simple analgesics >= 15 days/month in the 3 months prior to Visit 1 per investigator's judgment or during the baseline period.

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 60 mg<br>Taken once daily | Drug: Atogepant 60 mg<br>* Tablets containing 60 mg atogepant<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with at Least 1 Treatment Emergent Adverse Event |  | Across the 52-week treatment period | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants with Clinically Significant Laboratory Values (Chemistry, Hematology, Urinalysis) as assessed by the Investigator |  | Across the 52-week treatment period | 
| Percentage of Participants with Clinically Significant Electrocardiograms (ECGs) Findings as assessed by the Investigator |  | Across the 52-week treatment period | 
| Percentage of Participants with Clinically Significant Vital Sign Measurements as assessed by the Investigator |  | Across the 52-week treatment period | 
| Columbia-Suicide Severity Rating Scale (C-SSRS) Assessing Suicidal Ideation and Behaviour using 5-Point Scales | A clinician-rated instrument that reports the severity of both suicidal ideation and behavior. Suicidal ideation is 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). More than 1 classification can be selected provided they represent separate episodes. (Minimum total score 0, maximum total score 5; higher total scores indicate more suicidal ideation and/or suicidal behavior) | Across the 52-week treatment period | 

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