A Phase 3 interventional study of Rimegepant/BHV3000 and Matching placebo in Pediatric Migraine, sponsored by Pfizer. Recruiting at 246 sites in 9 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-27.
Sponsored by Pfizer · Phase 3, Interventional, and Treatment
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.
1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.
This study's planned enrollment of 2,100 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.
Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Drug: Rimegepant/BHV3000
Matching 75 mg or 50 mg ODT placebo
Drug: Matching placebo
Drug page: Rimegepant
BHV3000 (rimegepant) 75 mg or 50 mg ODT
Matching 75 mg or 50 mg ODT placebo
To evaluate the efficacy of rimegepant compared with placebo 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.
Pain freedom will be assessed in adolescent population (≥ 12 to \< 18 years of age) on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).
Time frame: 2 hours post-dose
To compare rimegepant with placebo for pain freedom in children and adolescents combined.
Pain freedom will be assessed in children and adolescents (≥ 6 to \< 18 years of age) using a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe). Pain freedom will be assessed in children (\> 6 to \< 12 years of age) using the 5-Face VAS (Face 5 = 'severe pain', Faces 4 and 3 = 'moderate pain', Face 2 = 'mild pain', Face 1 = 'no pain').
Time frame: 2 hours post-dose
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in adolescents.
Freedom from MBS (nausea, phonophobia or photophobia) will be measured using a binary scale (0=absent, 1=present).
Time frame: 2 hours post-dose
To compare rimegepant with placebo on the probabilities of requiring rescue medication within in adolescents.
Use of rescue medication will be assessed using the numbers of participants that take rescue medication.
Time frame: Within 24 hours and 48 hours of initial treatment
To compare rimegepant with placebo on sustained pain freedom in adolescents.
Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.
Time frame: 2 to 24 hours post-dose
To compare rimegepant with placebo on sustained pain freedom in adolescents.
Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.
Time frame: 2 to 48 hours post-dose
To compare rimegepant with placebo on the ability to function normally as reported on the Functional Disability scale in adolescents.
The proportion of participants able to function normally will be assessed using the number that self-report as "normal" on the Functional Disability scale.
Time frame: 2 hours post-dose
To compare rimegepant with placebo for pain freedom in children.
Pain freedom will be assessed using the number of children (≥ 6 to \< 12 years of age) that report no pain measured by a 5-Face VAS (Face 5 = 'severe pain', Faces 4 and 3 = 'moderate pain', Face 2 = 'mild pain', Face 1 = 'no pain').
Time frame: 2 hours post-dose
To compare rimegepant with placebo on freedom from the most bothersome symptom (MBS) associated with migraine in children and combined children and adolescents.
Freedom from the most bothersome symptom (nausea, phonophobia or photophobia) will be assessed using the number of participants that report the absence of MBS measured using a binary scale (0=absent, 1=present).
Time frame: 2 hours post-dose
To compare rimegepant with placebo on the probabilities of requiring rescue medication in children and combined children and adolescents.
The probabilities of requiring rescue medication will be assessed using the numbers of participants that take rescue medication within initial treatment.
Time frame: Within 24 hours and 48 hours of initial treatment.
To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents.
Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.
Time frame: 2 to 24 hours post-dose
To compare rimegepant with placebo on sustained pain freedom in children and combined children and adolescents.
Sustained pain freedom will be assessed using the number of participants that do not use any rescue medications and do not experience any headache pain post dose.
Time frame: 2 to 48 hours post-dose
To compare rimegepant with placebo on freedom from photophobia in adolescents, children and combined children and adolescents.
Freedom from photophobia will be assessed by the number of participants that report the absence of photophobia post dose that reported the presence of photophobia at baseline.
Time frame: 2 hours post-dose
To compare rimegepant with placebo on freedom from phonophobia in adolescents, children and combined children and adolescents.
Freedom from phonophobia will be assessed by the number of participants that report the absence of phonophobia post dose that reported the presence of phonophobia at baseline.
Time frame: 2 hours post-dose
To compare rimegepant with placebo on freedom from nausea in adolescents, children and combined children and adolescents.
Freedom from nausea will be assessed by the number of participants that report the absence of nausea post dose that reported the presence of nausea at baseline.
Time frame: 2 hours post-dose
To compare rimegepant with placebo on pain relief in adolescents, children and combined children and adolescents.
Pain relief will be assessed using the number of participants that report a pain level of moderate or severe at baseline and then report a pain level of none or mild post dose.
Time frame: 2 hours post-dose
To compare rimegepant with placebo in adolescents, children and combined children and adolescents on pain relief.
Time to first report of pain relief will be based on the first time point a participant reports a pain level of none or mild.
Time frame: Time to patients first report of pain relief of none or mild post dose up to 48 hours.
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Showing the first 100 of 246 sites across 9 countries. Choose a country and city above to see the rest.
Plan to share: Yes — Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/data_requests.
Data sharing details ↗ · www.pfizer.com
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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Studies of the drug tested here: Rimegepant