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A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 years of age
EU CTIS ID: 2024-512382-13-00
What this study is testing
To compare the efficacy of rimegepant to placebo as a preventive treatment for migraine in adolescents (12 to <18 years of age) with episodic migraine., as measured by the mean reduction from the observation period (OP) in the number of migraine days per month over the entire course of the doubleblind treatment (DBT) phase. (A month is defined as 4 weeks for the purpose of this protocol.)
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Participant has at least a 6-month history of migraine (with or without aura) consistent with a Diagnosis according to the International Classification of Headache Disorders, 3rd Edition, and including the following: - 14 or less headache days per month during the 3-month period prior to the Screening Visit. - 6 or more migraine days during the Observation Period. - 14 or less headache days during the Observation Period. - Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of >10 to ≤50 at the Baseline (Randomization) Visit. - Participants 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 Screening Phase, and the dose is not expected to change during the course of the study.
- Participants must have a weight of >15 kg. For EU countries only: Participants of 12 to <18 years of age must have a body weight >25 kg.
- Male and female participants 6 to <18 years; participants must be less than 18 at the time of signing assent / consent. Participants must not reach their 18th birthday on or before the Randomization (Baseline) visit. The participant, if a female who is sexually active and of childbearing potential must be willing to use one effective method of contraception to avoid pregnancy throughout the study.
- No 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.
- Signed written Informed Consent/Assent (where applicable, according to local regulations) prior to the conduct of any study-specific procedures.
You likely can't join if
- Participants with a history of basilar migraine, cluster headaches, or hemiplegic migraine, continuous migraine within 1 month prior to Screening Visit, history or diagnosis of complications of migraine, 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).
- The participant has a history of severe drug allergy or hypersensitivity or known hypersensitivity or intolerance to the excipients in rimegepant. History of anaphylaxis, documented hypersensitivity reaction, or clinically significant reaction to any drug.
- Clinically significant abnormality identified on the medical or laboratory evaluation. The following laboratory results are exclusionary: • Serum creatinine value >1.5 times the upper limit of the reference range (ULN). • Serum total bilirubin > ULN, unless the participant has known or suspected Gilbert’s syndrome. • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 x ULN. AST and/or ALT may be repeated once during the screening period for assessment of eligibility.
- Any “yes” response on the Columbia-Suicide Severity Rating Scale (C-SSRS) for the period of 30 days prior to Screening.
- 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 study.
- The participant has a confounding and clinically significant pain syndrome that may interfere with the participant’s ability to participate in this study. History of major psychiatric disorder or 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. History of suicidal behavior or the participant is at risk of self-harm or harm to others.
See the full eligibility criteria
Who can join
- Participant has at least a 6-month history of migraine (with or without aura) consistent with a Diagnosis according to the International Classification of Headache Disorders, 3rd Edition, and including the following: - 14 or less headache days per month during the 3-month period prior to the Screening Visit. - 6 or more migraine days during the Observation Period. - 14 or less headache days during the Observation Period. - Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of >10 to ≤50 at the Baseline (Randomization) Visit. - Participants 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 Screening Phase, and the dose is not expected to change during the course of the study.
- Participants must have a weight of >15 kg. For EU countries only: Participants of 12 to <18 years of age must have a body weight >25 kg.
- Male and female participants 6 to <18 years; participants must be less than 18 at the time of signing assent / consent. Participants must not reach their 18th birthday on or before the Randomization (Baseline) visit. The participant, if a female who is sexually active and of childbearing potential must be willing to use one effective method of contraception to avoid pregnancy throughout the study.
- No 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.
- Signed written Informed Consent/Assent (where applicable, according to local regulations) prior to the conduct of any study-specific procedures.
What rules you out
- Participants with a history of basilar migraine, cluster headaches, or hemiplegic migraine, continuous migraine within 1 month prior to Screening Visit, history or diagnosis of complications of migraine, 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).
- The participant has a history of severe drug allergy or hypersensitivity or known hypersensitivity or intolerance to the excipients in rimegepant. History of anaphylaxis, documented hypersensitivity reaction, or clinically significant reaction to any drug.
- Clinically significant abnormality identified on the medical or laboratory evaluation. The following laboratory results are exclusionary: • Serum creatinine value >1.5 times the upper limit of the reference range (ULN). • Serum total bilirubin > ULN, unless the participant has known or suspected Gilbert’s syndrome. • Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 x ULN. AST and/or ALT may be repeated once during the screening period for assessment of eligibility.
- Any “yes” response on the Columbia-Suicide Severity Rating Scale (C-SSRS) for the period of 30 days prior to Screening.
- 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 study.
- The participant has a confounding and clinically significant pain syndrome that may interfere with the participant’s ability to participate in this study. History of major psychiatric disorder or 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. History of suicidal behavior or the participant is at risk of self-harm or harm to others.
- The participant has a current diagnosis or history of substance abuse (excluding nicotine and caffeine) or alcohol abuse (DSM-5®19 criteria) < 2 years prior to the Screening Visit, as verified with legal representative(s) and in the opinion of the Investigator.
- The participant has a history of cancer.
- 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.
- The participant has or has had medical conditions that is/are considered clinically relevant in the context of the study.
- The participant has one or more clinically significant out-of-range vital signs at the Screening or Baseline (Randomization) Visit.
- The participant has a current diagnosis of viral hepatitis or a history of liver disease.
- The participant has a known history of hepatitis B surface antigen (HBsAg), hepatitis C virus antibody (anti-HCV), or human immunodeficiency virus (HIV), unless the participant has a CD4+ count >200 and undetectable viral load.
The study team makes the final eligibility decision.
Where it's taking place
- Japan
- Canada
- United States
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Japan; Canada; United States. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.