Efficacy and Safety Study of Rimegepant for Migraine Prevention in Japanese Subjects (Japan Only)

Study Overview
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Brief Summary
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This study is being conducted to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the prevention of migraine.

Official Title
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A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rimegepant for Migraine Prevention in Japanese Subjects

Conditions
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Migraine

Intervention / Treatment
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* Drug: Rimegepant
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has at least 1 year history of migraine (with or without aura) consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition, including the following: Age of onset of migraines prior to 50 years of age Migraine attacks, on average, lasting 4 to 72 hours if untreated Per subject report, 4 to18 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the Screening Visit (month is defined as 4 weeks for the purpose of this protocol) 4 or more migraine days during Observation Period Not more than 18 headache days during the Observation Period Ability to distinguish migraine attacks from tension/cluster headaches Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Observation Period, and the dose is not expected to change during the course of the study. Subjects with contraindications for use of triptans may be included provided they meet all other study entry criteria Exclusion Criteria: Subject has a history of migraine with brainstem aura (basilar migraine) or hemiplegic migraine Subjects with headaches occurring 19 or more days per month (migraine or non-migraine) in any of the 3 months prior to the Screening Visit. History of use of analgesics (e.g. nonsteroidal anti-inflammatory drugs [NSAIDs] or acetaminophen) on ≥ 15 days per month during the 3 months (12 weeks) prior to the Screening Visit. Subject with a history of HIV disease Subject history with current evidence of uncontrolled, unstable or recently diagnosed cardiovascular disease, such as ischemic heart disease, coronary artery vasospasm, and cerebral ischemia. subjects with Myocardial Infarction (MI), Acute Coronary Syndrome (ACS),Percutaneous Coronary Intervention (PCI), cardiac surgery, stroke or transient ischemic attack (TIA) during the 6 months prior to screening Uncontrolled hypertension (high blood pressure), or uncontrolled diabetes (however subjects can be included who have stable hypertension and/or diabetes for at least 3 months prior to being enrolled) Subject has a current diagnosis of major depression, other pain syndromes, psychiatric conditions, dementia, or significant neurological disorders (other than migraine) that, in the Investigator's opinion might interfere with study assessments. Subject has a history of gastric, or small intestinal surgery (including Gastric Bypass, Gastric Banding, Gastric Sleeve, Gastric Balloon, etc.), or has disease that causes malabsorption The subject has a history of current or evidence of any significant and/ or unstable medical conditions (e.g., history of congenital heart disease or arrhythmia, known suspected infection, hepatitis B or C, or cancer) that, in the investigator's opinion, would expose them to undue risk of a significant adverse event (AE) or interfere with assessments of safety or efficacy during the course of the trial. History of, treatment for, or evidence of, alcohol or drug abuse within the past 12 months or subjects who have met DSM-V criteria for any significant substance use disorder within the past 12 months from the date of the screening visit. Participation in any other investigational clinical trial while participating in this clinical trial

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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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rimegepant<br>Randomization Phase: one 75 mg rimegepant (BHV3000) oral disintegration tablet every other day until Week 12 | Drug: Rimegepant<br>* Randomization Phase: Rimegepant (BHV3000) 75 mg orally disintegrating tablet every other day until Week 12<br>* Other names: BHV3000;|
| Placebo Comparator: Placebo<br>Randomization Phase: one matching placebo every other day until week 12 | Drug: Placebo<br>* Randomization Phase: Placebo tablet to match Rimegepant every other day until Week 12<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction from baseline in the mean number of migraine days per month in the last four weeks (week 9 to 12) of the double-blind treatment (DBT) phase |  | Weeks 9 to 12 of DBT phase | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants that have least a 50% reduction from baseline in the mean number of moderate to severe migraine days per month in the last 4 weeks of the double-blind treatment (DBT) phase |  | Weeks 9 to 12 of DBT phase | 
| Reduction from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment (DBT) phase |  | Observation Period (OP) and Week 1 to 12 of DBT Phase | 
| Frequency of use of acute migraine specific medication (i.e., triptans and ergotamines) in the last 4 weeks of the double-blind treatment phase |  | Weeks 9 to 12 of DBT Phase | 
| Reduction from baseline in the mean number of migraine days per month in the first 4 weeks of the double-blind treatment phase |  | OP and Weeks 1 to 4 of DBT Phase | 
| Change from baseline in the Migraine-Specific Quality-of-Life Questionnaire v 2.1 role function - restrictive domain score at Week 12 of the double-blind treatment phase |  | Baseline, Week 12 of DBT Phase | 
| Change from baseline in the Migraine Disability Assessment total score at Week 12 of the double-blind treatment phase |  | Baseline, Week 12 of DBT Phase | 
| Change from baseline in the EQ-5D-5L score at Week 12 of the double blind treatment phase |  | Baseline, Week 12 of DBT Phase | 
| Number of participants with adverse events (AEs), serious adverse events (SAEs), AEs leading to drug discontinuation |  | Through study completion, 52 weeks | 
| Number of participants with clinical significant laboratory abnormalities |  | Through study completion, 52 weeks | 
| Frequency of ALT or AST > 3x ULN with concurrent elevations in bilirubin >2x ULN in subjects treated with rimegepant |  | Through study completion, 52 weeks | 
| Number of participants with hepatic-related adverse events (AEs) and the frequency of hepatic-related treatment discontinuations in subjects treated with rimegepant |  | Through study completion, 52 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Migraine, Headache, Migraine Prevention