Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine (NCT04743141) | Clinical Trial Compass
RecruitingPhase 3
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
United States, Poland, Spain600 participantsStarted 2021-04-28
Plain-language summary
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).
Who can participate
Age range
6 Years – 17 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. History of migraine (with or without aura) for ≥ 6 months before Screening.
. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.
. 1 or more migraine days requiring treatment during the Observation Phase.
. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.
. Ability to distinguish between migraine and other types of headaches.
. Weight \> 15 kg. For EU countries only: Participants 12 to \< 18 years of age must have a body weight of \>25kg.
. Adequate venous access for blood sampling.
. Male and female participants 6 to \< 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).
Exclusion criteria
. History of cluster headache or hemiplegic migraine headache.
. Confounding and clinically significant pain syndrome.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities
. Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded).
. History of suicidal behavior or at risk of self-harm/harm to others.
. History of major psychiatric disorder.
. Current diagnosis or history of substance abuse
. Reported current use of or tested positive at Screening for drugs of abuse.