Testing Rimegepant/BHV3000 against a placebo for pediatric migraine
Official title: Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age
- Phase 3
- 2 groups
- One site, in Sherbrooke
- Recruiting
Interventions
- Medication
Rimegepant/BHV3000
BHV3000 (rimegepant) 75 mg or 50 mg ODT
- Medication
Matching placebo
Matching 75 mg or 50 mg ODT placebo
Canadian Sites (2)
1 of 2 recruiting
- Recruiting
Kelowna Health & Memory Centre
Kelowna BC, British Columbia
- Not currently recruiting
Diex Recherche Sherbrooke Inc
Sherbrooke, Quebec
Eligibility Criteria
See who this study is looking for20 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more →, with attacks lasting \> 3 hours without treatment, and attacks occurring at intervals \> 24 hours.
- +History of migraine (with or without aura) for \> 6 months before ScreeningScreeningThe checks done before joining, to see whether a study fits.Read more → according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s).
- +Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline VisitBaselineYour starting measurements, taken before treatment begins.Read more →, and the dose is not expected to change during the course of the study.
- +Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \[biologic or small molecule\], during the treatment phases.
- +Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
- +Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
- +Verbally distinguish between migraine and other types of headaches.
- +Participants must have a weight \> 40 kg at the Screening Visit.
- +Adequate venous access for blood sampling.
- +Male and female participants ≥ 6 to \< 18 years of age (participants must not reach their 18th birthday during the study).
Exclusion
- −Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy
- −Current diagnosis of viral hepatitis or a history of liver disease.
- −History of cluster headache or hemiplegic migraine headache.
- −Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
- −Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening VisitScreeningThe checks done before joining, to see whether a study fits.Read more →. Participants with a lifetime history of psychosis and/or mania.
- −History of suicidal behavior or major psychiatric disorder.
- −Current diagnosis or history of substance abuse; positive drug test at Screening.
- −History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning.
- −Recent or planned surgery, requiring general anesthesia, \<8 weeks prior to the Screening Visit.
- −Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
There are 2 groups in this study.
Group A, the comparison group, receives Rimegepant/BHV3000.
Registry label: A: BHV3000 (active drug)
Group B, the placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group, receives Matching placebo.
Registry label: B: Placebo
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
One group receives a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → — a dummy treatment with no active medicine in it.
One group receives an existing treatment, so the two can be compared.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists an age range of 6 years to 17 years.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 2,100 people.
The study is currently expected to finish around January 2029.
The main measurement is taken over: 2 hours post-dose.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
To evaluate the efficacy of rimegepant compared with placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → in the acute treatment of migraine in adolescent population (≥ 12 to <18 years of age) as measured by pain freedom using the number of patients reporting no pain — measured over 2 hours post-dose.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT04649242 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About Rimegepant/BHV3000Drug
BHV3000 (rimegepant) 75 mg or 50 mg ODT
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
About Matching placeboDrug
Matching 75 mg or 50 mg ODT placebo
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: an age range of 6 years to 17 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
Yes. This study includes a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group — a dummy treatment with no active medicine in it.
One group receives an existing treatment so the two can be compared.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
You, the study team, and the people analysing the results would all be kept unaware of which group you are in until the study ends.
Which group you would be placed in is decided by chance, like a coin flip — not by you and not by your doctor.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists an age range of 6 years to 17 years.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.maximumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: 2 hours post-dose.
The study as a whole is currently expected to finish around 2029-01-09.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 2,100 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 21 locations, including: Kelowna BC, British Columbia, Canada; Sherbrooke, Quebec, Canada; Ann Arbor, Michigan, United States; Grand Rapids, Michigan, United States; Kalamazoo, Michigan, United States; Royal Oak, Michigan, United States, and 15 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
About This Trial
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.
Other Sites (34)
Michigan Head Pain & Neurological Institute
Ann Arbor, Michigan, United States
Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group
Grand Rapids, Michigan, United States
Corewell Health, Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Wellnow Urgent Care and Research
Kalamazoo, Michigan, United States
Beaumont Hospital Royal Oak Campus
Royal Oak, Michigan, United States
Brackenridge Outpatient Research Pharmacy
Rochester, Minnesota, United States
Clinical Research Trials Unit
Rochester, Minnesota, United States
Mayo Clinic
Rochester, Minnesota, United States
Boeson Research
Great Falls, Montana, United States
Boeson Research
Kalispell, Montana, United States
Heart & Hands Midwifery
Kalispell, Montana, United States
Blue Moose Pediatrics
Missoula, Montana, United States
Boeson Research Laboratory
Missoula, Montana, United States
Boeson Research
Missoula, Montana, United States
Dent Neurosciences Research Center
Amherst, New York, United States
True North Neurology
Commack, New York, United States
Northwell Health/ Division of Pediatric Neurology
Lake Success, New York, United States
NYU Langone Hospital-Long Island, Clinical Research Center
Mineola, New York, United States
NYU Langone Hospital-Long Island, Pediatric Neurology
Mineola, New York, United States
New York Neurology Associates
New York, New York, United States
And 14 more sites worldwide.
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.