A Study to Learn About the Efficacy and Safety of Rimegepant for the Acute Treatment of Migraine in Children and Adolescents.

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• Target Disease Exclusion a. Participant has a history of cluster headache or hemiplegic migraine headache. b. The participant has a continuous migraine (defined as an unrelenting headache) during within 1 month prior to Screening Visit.c. The participant has a history or diagnosis of persistent aura without infarction, migrainous infarction, migraine aura-triggered seizure, chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or unusual migraine subtypes such as hemiplegic migraine (sporadic and familial), ophthalmoplegic migraine, or migraine with neurological accompaniments that are not typical of migraine aura (diplopia, altered consciousness, or long duration). d. The participant has a confounding and clinically significant pain syndrome that may interfere with the participant’s ability to participate in this study.
• Medical History and Concurrent Diseases a. The participant has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania are excluded. b. History of suicidal behavior or the participant is at risk of self-harm or harm to others. c. History of major psychiatric disorder. Participants with anxiety disorder and/or mild major depressive disorder are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication for each disorder. Participants must have been on a stable dose within the 3 months before the Baseline Visit. d. The participant has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (DSM-5® criteria) < 2 years prior to the Screening Visit, as verified with legal representative(s) and in the opinion of the Investigator. e. The participant has reported current use of, or has tested positive at the Screening visit for, drugs of abuse (amphetamines, barbiturates, benzodiazepines, cannabinoids, cocaine, methadone, opiates, MDMA, methamphetamines, oxycodone, phencyclidine). Marijuana and all forms of ingested or inhaled cannabidiol and tetrahydrocannabinol containing products are prohibited. i. Participants who are positive at screening for drugs of abuse, and who are on a prescribed medication for an approved indication (eg, ADHD), will be allowed into the study at the Investigator’s discretion. This determination by the Investigator must be well documented in the source medical records. The stimulant dose must be stable from 3 months prior to baseline until the end of treatment visit occurs. f. The participant has a history of cancer. g. The participant has any other disorder for which the treatment takes priority over treatment of migraine or is likely to interfere with study treatment or safety assessments.h. The participant has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator’s opinion, likely to affect central nervous system functioning. i. The participant has had recent or planned surgery, requiring general anesthesia, <8 weeks prior to the Screening Visit. j. The participant has or has had one or more of the following conditions that is/are considered clinically relevant in the context of the study: i. Uncontrolled hypertension ii. Cardiovascular disease iii. Cardiomyopathy iv. Serious heart rhythm abnormalities v. Cerebrovascular disease (for example CNS Vascular ischemia) vi. Thromboembolic event vii. Diabetes viii. Raynaud’s disease ix. Life-threatening allergy (for example anaphylaxis) k. The participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding). l. The participant has one or more clinically significant out-of-range vital signs at the Screening or Baseline Visit. m. The participant has a current diagnosis of active viral hepatitis or a medical history of chronic liver disease. n. The participant has known infection with HIV, unless participant has CD4+ count >200 and undetectable viral load.
• Allergies and Adverse Drug Reactions a. The participant has a history of severe drug allergy or hypersensitivity or known hypersensitivity or intolerance to the excipients in rimegepant. b. History of drug or other allergy which, in the opinion of the investigator, makes the participant unsuitable for participation in the study
• ECG and Laboratory Test Findings a. Clinically significant abnormality identified on the medical or laboratory evaluation. A participant with a clinical abnormality or laboratory parameters outside the reference range may be included only if the investigator considers the finding not clinically significant, that it will not introduce additional risk factors, nor interfere with the study procedures. The following laboratory values are exclusionary: i. Serum creatinine value >1.5 x ULN ii. Serum Total bilirubin > ULN, unless participant has known or suspected Gilbert’s Syndrome iii. AST or ALT >2 x ULN (AST and/or ALT may be repeated once during the Screening Phase for assessment of eligibility) b. The participant has evidence of organ dysfunction or any clinically significant deviation from normal on physical examination, vital signs, 12-lead electrocardiogram (ECG), or clinical laboratory determinations beyond what is consistent with the target population. c. The participant has, at the Screening Visit: an abnormal ECG that is clinically significant based on the investigator’s evaluation of the central reader’s interpretation (Any evaluation of QT interval should be based on the Fridericia correction where QTcF = QT/RR0.33).
• Other Exclusion Criteria a. The participant has a sibling, or member of the same household, that has or will be participating in the BHV3000-311 study. b. Any yes response on the Columbia-Suicide Severity Rating Scale (C-SSRS) for the period of 30 days prior to Screening. c. The participant has been enrolled in a clinical research study involving the administration of an investigational or marketed drug or device within 30 days prior to the first dosing, administration of a biological product in the context of a clinical research study within 90 days prior to the first dosing, or concomitant participation in an investigational study involving no drug or device administration.d. The participant has been exposed to any calcitonin gene-related peptide (CGRP) receptor antagonist treatment or CGRP antibody (including exposure in a study investigating a CGRP antagonist or antibody) <6 months prior to the Screening Visit. e. Prisoners or participants who are incarcerated, i.e. Children’s residential facilities. f. Participants who are compulsorily detained for treatment of either a psychiatric or physical (e.g., infectious disease) illness. g. Participation in any other investigational clinical trial while participating in this clinical trial. Participants in a COVID-19 mRNA vaccine study (vaccine must be authorized under emergency use authorization or approval within the respective country) at least 30 days post last dose of the vaccine are permitted to be screened for this study. h. The participant has a clinically significant history of depression or suicidal thoughts within the previous 6 months prior to Screening, as verified with legal representative(s) and in the opinion of the Investigator. i. The participant has a physical finding in the mouth or tongue that would be likely to interfere with successful completion of the dosing procedure (orthodontic braces are permitted). j. The participant has a history of intolerance to venipuncture. k. The participant is, in the investigator’s opinion, unlikely to comply with the protocol or is unsuitable for any reason (including any known, suspected, or confirmed infections in the participant or participant’s parent(s)/legal representative(s) that may put the participant or study staff at risk [according the study site guidelines]).l. Participation in the BHV3000-121 study.m. Children or grandchildren who are direct descendants of investigator site staff or sponsor and sponsor delegate employees directly invlolved in the conduct of the study.
• Prohibited Medications a. The participant has a disease or takes medication that could, in the investigator’s opinion, interfere with the assessments of safety or tolerability, or interfere with the conduct or interpretation of the studyb. Please see Section 5.4 for prohibited medications and Section 5.5 for allowable prophylactic and standard of care medications