Long-Term Safety Study of BHV3000 for the Acute Treatment of Migraine in Chinese Subjects

Study Overview
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Brief Summary
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This trial is to evaluate the long-term safety and tolerability of Rimegepant 75mg ODT in Chinese subjects with migraine

Official Title
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A Multicenter, Open Label, Long-term Safety Study of BHV3000 for the Acute Treatment of Migraine in Chinese Subjects

Conditions
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Acute Migraine

Intervention / Treatment
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* Drug: Rimegepant 75mg Orally Disintegrating Tablets (ODT)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: At least a one-year history of migraines (with or without aura), consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd edition beta version, including the following: Age of onset of migraines prior to 50 years of age Migraine attacks, on average, lasting 4 - 72 hours if untreated 6-18 migraine attacks of moderate or severe intensity per month within the last 3 months prior to the Screening Visit 6 or more migraine days requiring treatment during Observation Phase 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 dose for at least 2 months prior to the Baseline Visit, 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 Age and Reproductive Status: Male or female subjects ≥ 18 years Women of childbearing potential (WOCBP) and nonsterilized men must voluntarily use 2 acceptable methods of contraception to avoid pregnancy and to minimize the risk of pregnancy from signing of informed consent through 56 days after study drug administration. WOCBP is defined in Section 5.6. Men who have had a vasectomy at least 6 months prior to the Screening Visit are considered surgically sterile Women of childbearing potential (WOCBP) and nonsterilized men must voluntarily use 2 acceptable methods of contraception to avoid pregnancy and to minimize the risk of pregnancy from signing of informed consent through 56 days after study drug administration. WOCBP is defined in Section 5.6. Men who have had a vasectomy at least 6 months prior to the Screening Visit are considered surgically sterile Exclusion Criteria: Target Disease Exclusion: * Subjects has a history of basilar migraine with brain stem aura or hemiplegic migraine Medical History and Comorbidities: History of HIV disease Current evidence of poorly controlled, unstable, or recently diagnosed cardiovascular disease such as ischemic heart disease, coronary vasospasm, and cerebral ischemia. Myocardial infarction (MI), acute coronary syndrome (ACS), percutaneous coronary intervention (PCI), cardiac surgery, stroke, or transient ischemic attack (TIA) during 6 months prior to screening Poorly controlled hypertension (high blood pressure) or poorly controlled diabetes (but subjects with stable hypertension and/or diabetes for at least 3 months prior to screening may be included in the study). Blood pressure greater than 150 mmHg systolic or 100 mmHg diastolic after 10 minutes of rest is exclusionary Subjects with a current diagnosis of major depression or a major depressive episode within the last 12 months, other pain syndromes, psychiatric disorders, dementia, or significant neurological disorders (other than migraine) that, in the opinion of the investigator, might interfere with study assessments History of gastric or small intestinal surgery (including gastric bypass, gastric banding, gastric sleeve, gastric water ball, etc.) or diseases resulting in malabsorption Subject has a history or diagnosis of Gilibert's Syndrome or any other active hepatic or biliary disorder History or presence of significant and/or unstable medical conditions (e.g., history of congenital heart disease or cardiac arrhythmia, known suspected infection, hepatitis B or C or neoplasm) that, in the opinion of the investigator, would expose the subjects to undue risk of a significant adverse events (AE) or interfere with the assessment of safety or effectiveness during the trial History or evidence of alcohol or drug abuse within the past 12 months, or treatment for alcohol or drug abuse, or meeting Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-V) criteria for any significant substance abuse disorder within the past 12 months prior to the Screening Visit Subjects should be excluded if they have a positive drug screen for drugs of abuse and are considered medically significant by the investigator, would compromise subject safety, or interfere with the interpretation of study results. In addition: Subjects with detectable levels of cocaine, amphetamines, and phencyclidine in drug abuse screening need to be excluded. Subjects who are positive for amphetamines on the urine drug screen may have their urine samples evaluated for further analysis at the investigator's discretion to rule out a false positive result Subjects with detectable levels of marijuana during substance abuse screening may not be excluded if they do not meet DSMV criteria for substance abuse or dependence in the subject's opinion as documented by the investigator, and a positive result does not signal a clinical condition that would impact the subject safety or interpretation of the study results Diagnosis of hematologic or solid malignancy within 5 years prior to screening. Subjects with a history of localized basal cell or squamous cell skin cancer may be included in the study if they are cancer-free prior to the screening visit for this study Subjects with a current diagnosis of schizophrenia, major depression requiring treatment with atypical antipsychotics, bipolar disorder or borderline personality disorder Body mass index (BMI) ≥ 35 kg/ m2 Subjects with a history of gallstones or cholecystectomy Use of St. John's Wort, products containing St. John's Wort, Coltsfoot root, or extracts within 14 days prior to the baseline visit Use of narcotic drugs such as opioids (e.g., morphine, codeine, oxycodone, and hydrocodone) within 2 days prior to the baseline visit. Allergy and Adverse Reactions: *. History of drug or other allergy that, in the opinion of the investigator, would make the subject unsuitable for participation in the study

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Rimegepant 75mg Orally Disintegrating Tablets (ODT)<br>One rimegepant (BHV3000) 75mg orally disintegrating tablet (up to 1 tablet per day) | Drug: Rimegepant 75mg Orally Disintegrating Tablets (ODT)<br>* One rimegepant (BHV3000) 75mg orally disintegrating tablet (up to 1 tablet per day) at the time of their migraine attack<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Safety and Tolerability of Adverse events and Laboratory Abnormalities of 75mg Rimegepant ODT (PRN) | Number of participants with Adverse Events (AEs) occurring in ≥5% of subjects, related Serious AEs (SAEs), AEs Leading to Study Drug Discontinuation in the Long term treatment Phase, number of Participants with Clinically Significant Laboratory Abnormalities in the Long term treatment Phase. Measured by Adverse Events that occur in ≥5% of subjects by intensity; related serious adverse events (SAEs); and adverse events leading to study drug discontinuation, significant changes in physical exam and clinically significant laboratory test changes as compared to the baseline levels. Clinically significant laboratory abnormalities defined as Grade 3 to 4 laboratory test results according to numeric laboratory test criteria found in Common Technical Criteria for Adverse Events (CTCAE) Version 5.0. | Through study completion, 52 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of headache days and severity of migraine attacks analyzed together. | Change from Observation Period in the number of migraine days per 4 weeks during Long Term Treatment 1) over time by 4-week intervals and 2) overall average, by severity (total; moderate or severe) Subjects are instructed to report migraine status (yes, no, unable to recall) and severity (mild, moderate, severe, unable to recall) in their e-Diaries every day and will be measured as one endpoint. | 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