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AN INTERVENTIONAL, EFFICACY, AND SAFETY, PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN-LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE
EU CTIS ID: 2023-505601-16-00
What this study is testing
To compare the efficacy of rimegepant to placebo as a preventive treatment for migraine in adolescents with chronic migraine.
- 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
- Age and Sex: 1. Participants aged 12 to <18 years at the time of signing assent/consent. Participants must not reach their 18th birthday on or before the Randomization (Baseline) visit. • For EU countries and India ONLY: Participants must weigh greater than 40 kg
- Disease Characteristics: 2. 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 Edition1 including the following: • 15 or more headache days per month during the 3-month period prior to the Screening Visit. • 8 or more migraine days per month during the 3-month period prior to the Screening Visit. • 15 or more headache days during the OP. • 8 or more migraine days during the OP. • Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches. • Migraine attacks, on average, lasting 4 to 72 hours if untreated.
- Other Inclusion Criteria: 3. Signed Written Informed Consent: • The participant is able to understand the Informed Assent Document (IAD) and the participant’s parent(s)/legal representative(s) (according to local regulations) are/is able to read and understand the Informed Consent Document (ICD). • The participant has signed the IAD/ICD (according to local regulations) and the participant’s parent(s)/legal representative(s) have/has signed the ICD prior to the conduct of any study-specific procedures. • The participant must be able to read and comprehend written instructions and be willing to complete all questionnaires under supervision of legal representative(s) as required by the protocol.
You likely can't join if
- Target Disease Exclusion: • Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit. • Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome that may interfere with the participant’s ability to participate in this study as assessed by the principal investigator (PI).
- The following laboratory/electrocardiogram (ECG) values are exclusionary during the screening period: • Estimated glomerular filtration rate (eGFR)/creatinine clearance (CrCl) <45 mL/min/1.73m2. • Serum total bilirubin > upper limit of normal (ULN) (unless 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). • An abnormal ECG at the screening visit that is clinically significant based on the investigator’s evaluation of the central reader’s interpretation. Determinations of eligibility based on QT interval will be based on the Fridericia correction where QTcF= QT/(RR⁰.³³).
- Any medical condition or laboratory abnormality, including any clinically significant out-of-range vital signs, that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study (see Exclusion #10 for key parameters assessments for liver and renal function, and for cardiac evaluation).
- Any current psychiatric condition that is uncontrolled and/or untreated.
- Any “yes” response on the C-SSRS for the period of 30 days prior to Screening.
- History of alcohol abuse and/or illicit drug use meeting DSM-5®² criteria for substance use disorder within 6 months of screening (excluding nicotine and caffeine). • 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.
See the full eligibility criteria
Who can join
- Age and Sex: 1. Participants aged 12 to <18 years at the time of signing assent/consent. Participants must not reach their 18th birthday on or before the Randomization (Baseline) visit. • For EU countries and India ONLY: Participants must weigh greater than 40 kg
- Disease Characteristics: 2. 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 Edition1 including the following: • 15 or more headache days per month during the 3-month period prior to the Screening Visit. • 8 or more migraine days per month during the 3-month period prior to the Screening Visit. • 15 or more headache days during the OP. • 8 or more migraine days during the OP. • Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches. • Migraine attacks, on average, lasting 4 to 72 hours if untreated.
- Other Inclusion Criteria: 3. Signed Written Informed Consent: • The participant is able to understand the Informed Assent Document (IAD) and the participant’s parent(s)/legal representative(s) (according to local regulations) are/is able to read and understand the Informed Consent Document (ICD). • The participant has signed the IAD/ICD (according to local regulations) and the participant’s parent(s)/legal representative(s) have/has signed the ICD prior to the conduct of any study-specific procedures. • The participant must be able to read and comprehend written instructions and be willing to complete all questionnaires under supervision of legal representative(s) as required by the protocol.
What rules you out
- Target Disease Exclusion: • Continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit. • Atypical migraine types, complications of a migraine, or a confounding and clinically significant pain syndrome that may interfere with the participant’s ability to participate in this study as assessed by the principal investigator (PI).
- The following laboratory/electrocardiogram (ECG) values are exclusionary during the screening period: • Estimated glomerular filtration rate (eGFR)/creatinine clearance (CrCl) <45 mL/min/1.73m2. • Serum total bilirubin > upper limit of normal (ULN) (unless 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). • An abnormal ECG at the screening visit that is clinically significant based on the investigator’s evaluation of the central reader’s interpretation. Determinations of eligibility based on QT interval will be based on the Fridericia correction where QTcF= QT/(RR⁰.³³).
- Any medical condition or laboratory abnormality, including any clinically significant out-of-range vital signs, that may increase the risk of study participation or, in the investigator’s judgment, make the participant inappropriate for the study (see Exclusion #10 for key parameters assessments for liver and renal function, and for cardiac evaluation).
- Any current psychiatric condition that is uncontrolled and/or untreated.
- Any “yes” response on the C-SSRS for the period of 30 days prior to Screening.
- History of alcohol abuse and/or illicit drug use meeting DSM-5®² criteria for substance use disorder within 6 months of screening (excluding nicotine and caffeine). • 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.
- History of severe drug allergy (such as anaphylaxis, or known hypersensitivity or intolerance to rimegepant or its excipients).
- Current use of any prohibited concomitant medication(s).
- More than 1 medication taken for migraine prevention/prophylaxis. • Concomitant use of a CGRP receptor antagonist, such as Nurtec™ or others, monoclonal antibodies such as erenumab, fremanezumab, or others <6 months prior to the Screening Visit. • Prophylactic migraine medication discontinued less than 30 days prior to the Screening Visit. • Prophylactic migraine medication not being stable for at least 3 months (12 weeks) prior to the OP, or dose expected to change during the course of the study.
- Previous administration with an investigational product (drug or vaccine) within 30 days (or as determined by the local requirement) or 5 half-lives preceding the first dose of study intervention used in this study (whichever is longer). Participation in studies of other investigational products at any time during participation in this study is also exclusionary.
The study team makes the final eligibility decision.
Where it's taking place
- India
- Canada
- United States
- Japan
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 India; Canada; United States; Japan. 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.