Pediatric Migraine

The purpose of this trial is to evaluate how effective a study drug called rimegepant is in treating the symptoms of Pediatric Migraine. Researchers want to compare the investigational drug to placebo, which looks like the investigational drug but contains no active medication. In this study, the term “study drug” refers to either the investigational medication or placebo.

The investigational drug has not been approved by any regulatory authority for the treatment of pediatric migraine. It is only available in research studies like this one.  

Clinical Trials Listing:  https://clinicaltrials.gov/study/NCT04649242 

You will be asked to take the study drug or placebo once for 1 migraine. Participation will last about 118 days. During this time, you will be asked to meet with our study team up to 4 times to provide feedback about your experiences. You will be compensated for your time and travel to attend these visits. They will also perform study procedures to evaluate your wellbeing, including physical exams and taking vital signs.

During the screening period, which will occur over a period of up to 28 days, the study team will ask participants some questions and do some tests to see if they are eligible for the study. Participants will also be asked to stop taking any medications that are not allowed in the study.

If qualified, participants will be randomly assigned, like drawing straws, to one of 2 treatment groups to take either doses of placebo or rimegepant. A placebo is a tablet that looks like the study drug but contains no active ingredients. This study is double-blind, which means that neither participants nor the study team will know which treatment they are taking during the study.

Key Inclusion Criteria

1. Signed Written Informed Consent Form prior to the conduct of any study-specific procedures. The participant and the participant’s parent(s)/legal representative(s) (as required according to local regulations) are/is willing and able to attend study appointments within the specified time windows.
2. History of migraine (with or without aura) for > 6 months before Screening.
3. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment.
4. A history of attacks lasting approximately > 3 hours without treatment.
5. Participants on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 12 weeks prior to the Screening and the dose is not expected to change. May remain on one (1) medication with possible migraine prophylactic effects.

Key Exclusion Criteria

1. The participant has a history or diagnosis of migraine not meeting the defined criteria of third edition of International Classification of Headache Disorders (ICHD-3)for migraine with or without aura.
2. History of suicidal behavior or the participant is at risk of self-harm or harm to others.
3. History of major psychiatric disorder.
4. 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.
5. Any yes response on the Columbia-Suicide Severity Rating Scale (C-SSRS) for the period of 30 days prior to Screening.
6. The participant has been exposed to any calcitonin gene-related peptide (CGRP) receptor antagonist treatment or CGRP antibody <6 months prior to the Screening Visit. 

​Additional criteria will apply. All study-related visits, tests, and drugs will be provided at no cost. You may also be reimbursed for study-related travel expenses. 

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Please complete the form linked below, and a member of our study team will reach out to you.