Efficacy and Safety Study of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects (Japan Only)

Study Overview
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Brief Summary
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This study is being conducted to determine the appropriate dose of rimegepant in Japanese subjects, as well as to evaluate the efficacy, safety, and tolerability of rimegepant in Japanese subjects for the acute treatment of migraine.

Official Title
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Double-Blind, Randomized, Placebo-Controlled, Dose-Ranging Study to Evaluate the Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Japanese Subjects

Conditions
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Migraine

Intervention / Treatment
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* Drug: Rimegepant 25 MG
* Drug: Rimegepant 75 MG
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject has at least 1 year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorder, 3rd Edition, including the following: Migraine attacks present for more than 1 year with the age of onset prior to 50 years of age Migraine attacks, on average, lasting about 4-72 hours if untreated Not more than 8 attacks of moderate to severe intensity per month within the last 3 months Ability to distinguish migraine attacks from tension/cluster headaches Consistent migraine headaches of at least 2 migraine headache attacks of moderate or severe intensity in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening period Less than 15 days with headache (migraine or non-migraine) per month in each of the 3 months prior to the Screening Visit and maintains this requirement during the Screening Period. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months prior to the Screening Visit, and if 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 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 (e.g., schizophrenia), 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: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rimegepant 25 mg<br>Single dose of 25 mg orally disintegrating tablet of rimegepant | Drug: Rimegepant 25 MG<br>* Single dose of 25 mg orally disintegrating tablet of rimegepant<br>* Other names: BHV3000;|
| Experimental: Rimegepant 75 mg<br>Single dose of 75 mg orally disintegrating tablet of rimegepant | Drug: Rimegepant 75 MG<br>* Single dose of 75 mg orally disintegrating tablet of rimegepant<br>* Other names: BHV3000;|
| Placebo Comparator: Placebo<br>Matching placebo tablet | Drug: Placebo<br>* Matching placebo tablet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain freedom at 2 hours post-dose | Measured by the number of subjects that report no pain. Pain will be measured on a 4 point Likert scale (0=none, 1=mild, 2=moderate, 3=severe). | 2 hours post-dose | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pain relief at 2 hours post-dose. | Measured by the number of subjects that report a pain level of moderate or severe at baseline and then report a pain level of none or mild at two hours post-dose | Baseline, 2 hours post-dose | 
| Freedom from the Most Bothersome Symptom (MBS) associated with migraine at 2 hours post-dose. | Measured by the number of subjects that report the absence of their MBS at 2 hours post-dose. The MBS (nausea, phonophobia or photophobia) will be measured using a binary scale (0=absent, 1=present) | 2 hours post-dose | 
| Ability to function normally at 2 hours post-dose | Measured by the number of subjects that self-report as normal on the Functional Disability scale. The Functional Disability scale is a four-point scale: normal, mildly impaired, severely impaired, requires bedrest. | 2 hours post-dose | 
| Sustained pain relief from 2 to 24 hours post-dose | Measured by the number of subjects that do not use any rescue medications, and do not experience any moderate or severe headache pain through the time period of interest. | From 2 hours up to 24 hours post-dose | 
| Frequency of use of rescue medication within 24 hours of initial treatment. | Measured by the number of subjects that take rescue medication within 24 after administration of study medication | 24 hours post-dose | 
| Sustained pain relief from 2 to 48 hours post-dose | Measured by the number of subjects that do not use any rescue medications, and do not experience any moderate or severe headache pain through the time period of interest. | From 2 hours up to 48 hours post-dose | 
| Freedom from photophobia at 2 hours post-dose | Measured by tabulating the number of subjects that report the absence of photophobia at 2 hours post-dose in the subset of subjects that reported the presence of photophobia at headache baseline | Baseline, 2 hours post-dose | 
| Sustained pain freedom from 2 to 24 hours post-dose | Measured by the number of subjects that do not use any rescue medications, and do not experience any headache pain through the time period of interest | From 2 hours up to 24 hours post-dose | 
| Freedom from phonophobia at 2 hours post-dose | Measured by tabulating the number of subjects that report the absence of phonophobia at 2 hours post-dose in the subset of subjects that reported the presence of phonophobia at headache baseline | Baseline, 2 hours post-dose | 
| Sustained pain freedom from 2 to 48 hours post-dose. | Measured by the number of subjects that do not use any rescue medications, and do not experience any headache pain through the time period of interest. | From 2 hours up to 48 hours post-dose | 
| Freedom from nausea at 2 hours post-dose | Measured by tabulating the number of subjects that report the absence of nausea at 2 hours post-dose in the subset of subjects that reported the presence of nausea at headache baseline | Baseline, 2 hours post-dose | 
| Incidence of pain relapse from 2 to 48 hours post-dose | Measured by the number of subjects that are pain free at 2 hours post-dose and then have a headache of any severity (response of 1, 2 or 3 on the 4 point scale) within 48 hours after administration of study medication | From 2 hours up to 48 hours post-dose | 

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