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Rimegepant for Migraine Prevention in Children
Study Summary
This trial will compare the effects of rimegepant versus placebo on preventing migraines in children and adolescents.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- I've been on a stable dose of migraine prevention medication for at least 3 months.I am between 6 and 17 years old.I weigh at least 40 kg.I have not had untreated psychiatric conditions in the last 6 months.My child's daily activities are mildly or moderately disrupted by migraines.You have a serious mental health condition in your medical history.My migraines last between 4 to 72 hours without treatment.I have had a serious head injury or neurological condition that could affect my brain function.You have a history of trying to hurt yourself or others, or you are at risk of doing so.I have had 6 or more migraine days recently.My migraines last between 4 to 72 hours without treatment.You have a current or past problem with using drugs or alcohol.You can tell the difference between migraine headaches and other types of headaches by describing them in words.I've had 14 or fewer headache days each month for the last 3 months.I've had 14 or fewer headache days each month for the last 3 months.1) If you take medicine to prevent migraines, you can still join the study if you've been taking the same dose for at least 3 months before the screening and won't change it during the study.
2) People aged 6 to under 18 can join, as long as they are under 18 when they agree to take part.I have a history of specific severe headaches.I have had a constant headache for the last month.I have had complications due to my migraines.I have severe pain that could affect my participation in the study.I have had 6 or more migraine days recently.I had 14 or fewer headache days recently.If your Pediatric Migraine Disability Assessment Scale (PedMIDAS) score is between 11 and 50, showing mild to moderate disruption in daily activities, you may be eligible.I have had migraines for at least 6 months.I had 14 or fewer headache days recently.
- Group 1: Rimegepant / BHV3000
- Group 2: Matching Placebo
- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
Does Rimegepant / BHV3000 have a long history of research?
"Right now, there are 7 ongoing investigations into Rimegepant / BHV3000 with 3 of them being Phase 3 trials. Although the majority of these experiments are based in Vigo, Nebraska, 500 different locations worldwide are participating."
Does this clinical research include participants who are under 40 years old?
"According to the inclusion criteria, this trial is for patients aged 6-18. Out of the 35 clinical trials that exist for people under 18, this is one of them. In contrast, there are 126 clinical trials for people over 65."
Are there different test facilities around the country that are researching this new treatment?
"61 clinical trial sites are currently recruiting patients for this study. If you choose to enroll, it would be beneficial to select a location nearest to you in order to reduce travel time and expenses."
Could I possibly qualify to take part in this research project?
"This study is actively recruiting for 640 participants that suffer from migraines, specifically those aged 6 to 18 years old. It's important to note that potential subjects must have a stable prophylactic medication dosage for at least 3 months and cannot be expected to change the dose during the course of the study. Additionally, candidates should expect 14 or less headache days per month and an average migraine duration of 4-72 hours if left untreated. Finally, those interested in participating must weigh at least 40kg (or 15kg if they are in the child cohort)."
Have there been other research projects like this one previously?
"Rimegepant / BHV3000 has undergone 7 clinical trials in 9 countries and 252 cities since 2019. The most recent study, sponsored by Biohaven Pharmaceuticals, Inc., was completed in 2020 with 60 participants. It successfully completed Phase 2 of drug approval. In total, 18291 have been conducted for Rimegepant / BHV3000."
What is the total number of individuals enrolled in this experiment?
"To complete this clinical trial, 640 individuals that satisfy the pre-determined inclusion criteria must be recruited. These patients can come from different medical practices, such as CICR in Fayetteville, North carolina and South Ogden Family Medicine in South Ogden, Utah."
When will Rimegepant / BHV3000 be available to the public?
"Rimegepant / BHV3000 is estimated to be a safe medication, as it has received a score of 3. This is due to the fact that this drug is currently in Phase 3 clinical trials, meaning that there is some evidence supporting its efficacy and multiple rounds of data supporting its safety."
If a patient is interested, how can they sign up for this research project?
"Yes, the trial is still open and recruiting patients. According to the listing on clinicaltrials.gov, the study was posted on February 28th, 2022 and last updated November 1st, 2022. They are looking for 640 participants at 61 different sites."
Who else is applying?
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How responsive is this trial?
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Most responsive sites:
- Advanced Investigative Medicine: < 48 hours
Average response time
- < 2 Days
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