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Rimegepant for Pediatric Migraine
Study Summary
This trial will test if a drug is safe to use for 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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- You are currently using or have a history of using drugs, and your drug test at the screening shows positive results.I am between 6 and 17 years old.I needed treatment for a migraine at least once during the observation period.You can tell the difference between migraines and other kinds of headaches.I've had 1-8 severe attacks a month in the last 2 months.I've had 1-8 severe attacks a month in the last 2 months.I have not had untreated mental health issues for the past 6 months.You can tell the difference between migraines and other types of headaches.I weigh at least 40 kg.I can have blood drawn without difficulty.I have had migraines for at least 6 months.I have a history of cluster or hemiplegic migraine headaches.I have severe pain that affects my daily life.You have a history of trying to hurt yourself or have a serious mental health condition.I have been on a stable dose of migraine prevention medication for at least 12 weeks.I needed treatment for a migraine at least once during the observation period.I weigh at least 40 kg.
- Group 1: Rimegepant / BHV3000
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- 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
What similar studies have been done using Rimegepant / BHV3000?
"Rimegepant / BHV3000 was first trialed in 2019 by Clinical Research Professionals. 8 such studies have been completed with 7 more currently underway, many of which are based in Chicago."
Is this a new kind of clinical trial?
"Rimegepant / BHV3000 is being trialled in 7 active studies located across 9 countries and 252 cities. The first trial, sponsored by Biohaven Pharmaceuticals, Inc., was completed in 2019. The Phase 2 drug approval stage trial involved 60 participants. Since the initial study, 8 more have been completed."
Could I be a potential candidate for this research?
"Eligible participants for this migraine clinical trial must be between 6-18 years old. A total of 600 patients will be recruited for this study."
Are middle-aged adults eligible for this type of treatment?
"In order to qualify for this particular study, potential patients must be between 6 and 18 years old-- which falls in the age range for 35 other trials. There are 118 clinical trials for patients outside of this age bracket."
How does Rimegepant / BHV3000 impact patients safety?
"Rimegepant / BHV3000 is considered to be safe, as it has received a score of 3. This is due to the fact that this drug is in Phase 3 of clinical trials, meaning that there is some data supporting both its efficacy and safety."
How many human subjects will be participating in this clinical trial?
"600 individuals are required to start the clinical trial. The sponsor, Biohaven Pharmaceuticals, Inc., will be managing the study from various locations, such as the Chicago Headache Center & Research Institute located in Chicago, Illinois and the Children's Healthcare of Atlanta in Atlanta, Georgia."
Is this trial being conducted in numerous locations throughout the United States?
"Besides Chicago Headache Center & Research Institute in Chicago, Illinois, and Children's Healthcare of Atlanta in Atlanta, Georgia, other recruitment sites for this study include Dent Neurosciences Research Center in Amherst, New york, amongst 95 other locations."
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