Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

June 4, 2026 updated by: Pfizer

A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age

The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to <18 years with episodic migraine.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

640

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Canada
    • British Columbia
      • Vancouver, British Columbia, Canada, V6H 3V4
        • Terminated
        • Children's and Women's Health Centre of British Columbia
  • France
      • Créteil, France, 94000
        • Recruiting
        • Centre Hospitalier Intercommunal de Créteil
      • Montpellier, France, 34295
        • Active, not recruiting
        • CENTRE HOSPITALIER UNIVERSITAIRE de MONTPELLIER
      • Toulouse, France, 31059
        • Recruiting
        • Hôpital des Enfants
  • Italy
      • Brescia, Italy, 25069
        • Recruiting
        • Asst Spedali Civili Di Brescia
    • BARI / Puglia
      • Bari, BARI / Puglia, Italy, 70132
        • Recruiting
        • UOSVD Centro Epilessia ed EEG dellEta Evolutiva
    • Latina/lazio
      • Latina, Latina/lazio, Italy, 04100
        • Recruiting
        • Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic
    • Lazio
      • Rome, Lazio, Italy, 00166
        • Recruiting
        • IRCCS San Raffaele
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • Recruiting
        • Istituto Neurologico "Carlo Besta" Fondazione IRCCS
    • Rome/lazio
      • Rome, Rome/lazio, Italy, 00165
        • Recruiting
        • Divisione di Neurologia, Ospedale Pediatrico Bambino Gesu
  • Japan
    • Fukuoka
      • Kasuga-shi, Fukuoka, Japan, 816-0802
        • Recruiting
        • Jinnouchi Neurosurgical Clinic
    • Gunma
      • Kiryu-shi, Gunma, Japan, 376-0035
        • Recruiting
        • Hikita Pediatric Clinic
    • Hyōgo
      • Higashinada-ku Kobe-shi, Hyōgo, Japan, 658-0064
        • Recruiting
        • Konan Medical Center
      • Nishinomiya-shi, Hyōgo, Japan, 663-8204
        • Recruiting
        • Yamaguchi Clinic
    • Ibaraki
      • Mito, Ibaraki, Japan, 310-0015
        • Not yet recruiting
        • Mito Kyodo General Hospital
    • Kagoshima-ken
      • Kagoshima, Kagoshima-ken, Japan, 890-0052
        • Recruiting
        • Tanaka Neurosurgery & Headache Clinic
    • Kochi
      • Kochi, Kochi, Japan, 780-0051
        • Recruiting
        • Atago Hospital
    • Miyagi
      • Taihaku-ku Sendai-shi, Miyagi, Japan, 982-0014
        • Recruiting
        • Sendai Headache and Neurology Clinic
    • Osaka
      • Abeno-ku Osaka-shi, Osaka, Japan, 545-0053
        • Recruiting
        • Tennouji Dai Brain Clinic
      • Naniwa-ku, Osaka, Japan, 556-0015
        • Recruiting
        • Tominaga Clinic
    • Saitama
      • Chuo-ku Saitama-shi, Saitama, Japan, 338-8577
        • Recruiting
        • Saitama Neuropsychiatric Institute
    • Tokyo
      • Shibuya-ku, Tokyo, Japan, 151-0051
        • Recruiting
        • Tokyo Headache Clinic
      • Shinjuku-ku, Tokyo, Japan, 160-0023
        • Recruiting
        • Tokyo Medical University Hospital
  • Poland
    • Greater Poland Voivodeship
      • Poznan, Greater Poland Voivodeship, Poland, 61-731
        • Recruiting
        • Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 31-503
        • Recruiting
        • Wojewodzki Specjalistyczny Szpital Dzieciecy
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
        • Recruiting
        • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-064
        • Recruiting
        • NZOZ Neuromed M. i M. Nastaj Sp. P.
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 02-172
        • Recruiting
        • MTZ Clinical Research Powered by Pratia
    • Silesian Voivodeship
      • Katowice, Silesian Voivodeship, Poland, 40-123
        • Active, not recruiting
        • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
      • Katowice, Silesian Voivodeship, Poland, 40-689
        • Recruiting
        • Neurologia Slaska Centrum Medyczne
    • WOJ. Mazowieckie
      • Warsaw, WOJ. Mazowieckie, Poland, 02-121
        • Recruiting
        • Next Stage Sp. Z o.o.
  • Spain
      • Madrid, Spain, 28036
        • Recruiting
        • Instituto de Investigaciones del Sueño
      • Seville, Spain, 41013
        • Recruiting
        • Virgen del Rocio Hospital
      • Valencia, Spain, 46026
        • Recruiting
        • Hospital Universitario y Politécnico La Fe
    • Barcelona
      • Sabadell, Barcelona, Spain, 08208
        • Recruiting
        • Hospital Universitari Parc Tauli
    • Castille and León
      • Valladolid, Castille and León, Spain, 47003
        • Recruiting
        • Hospital Clinico Universitario de Valladolid (HCUV)
    • Galicia
      • Vigo, Galicia, Spain, 36312
        • Recruiting
        • Hospital Alvaro Cunqueiro
  • United States
    • Arkansas
      • Fort Smith, Arkansas, United States, 72901
        • Active, not recruiting
        • The Belinga Clinic
    • California
      • Hawthorne, California, United States, 90250
        • Recruiting
        • Advanced Investigative Medicine, Inc.
      • La Mesa, California, United States, 91942
        • Active, not recruiting
        • Velocity Clinical Research San Diego
    • Colorado
      • Colorado Springs, Colorado, United States, 80907
        • Active, not recruiting
        • Colorado Springs Neurological Associates
      • Fort Collins, Colorado, United States, 80528
        • Terminated
        • Advanced Neurosciences Research, Llc
    • District of Columbia
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Meridian Clinical Research, LLC
      • Washington D.C., District of Columbia, United States, 20016
        • Recruiting
        • Velocity Clinical Research, Washington DC
    • Florida
      • Edgewater, Florida, United States, 32132
        • Active, not recruiting
        • Accel Research Sites Network - Edgewater Clinical Research Unit
      • Hialeah, Florida, United States, 33012
        • Recruiting
        • Direct Helpers Research Center
      • Hollywood, Florida, United States, 33020
        • Terminated
        • New Med Research, Inc
      • Ormond Beach, Florida, United States, 32174
        • Active, not recruiting
        • Complete Health Research
      • Tamarac, Florida, United States, 33321
        • Recruiting
        • D&H Tamarac Research Center LLC
      • Tampa, Florida, United States, 33615
        • Recruiting
        • Santos Research Center, CORP
    • Georgia
      • Augusta, Georgia, United States, 30912
        • Recruiting
        • Augusta University
      • Sandy Springs, Georgia, United States, 30328
        • Active, not recruiting
        • WR-Mount Vernon Clinical Research, LLC
      • Savannah, Georgia, United States, 31406
        • Active, not recruiting
        • Meridian Clinical Research, LLC
      • Snellville, Georgia, United States, 30078
        • Active, not recruiting
        • Extraordinary Family Healthcare
      • Snellville, Georgia, United States, 30078
        • Active, not recruiting
        • Renew Health Clinical Research LLC
    • Idaho
      • Boise, Idaho, United States, 83704
        • Recruiting
        • Northwest Clinical Trials, Inc.
    • Illinois
      • Chicago, Illinois, United States, 60642
        • Terminated
        • Diamond Headache Clinic
    • Louisiana
      • New Orleans, Louisiana, United States, 70125
        • Recruiting
        • Nola Research Works, LLC
    • Mississippi
      • Clinton, Mississippi, United States, 39056
        • Recruiting
        • Safe Haven Clinical Research
    • Missouri
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri
      • Columbia, Missouri, United States, 65211
        • Recruiting
        • Roy Blunt NextGen Precision Health Building
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri-Clinical and Translational Sciences Unit
      • Columbia, Missouri, United States, 65212
        • Recruiting
        • University of Missouri Health Care - Investigation Pharmacy
    • Nebraska
      • Grand Island, Nebraska, United States, 68803
        • Recruiting
        • Velocity Clinical Research, Grand Island
      • Papillion, Nebraska, United States, 68046
        • Recruiting
        • Papillion Research Center/CCT Research
    • Nevada
      • Reno, Nevada, United States, 89502
        • Active, not recruiting
        • Renown Regional Medical Center
    • New York
      • Amherst, New York, United States, 14226
        • Active, not recruiting
        • Dent Neurosciences Research Center, Inc.
      • The Bronx, New York, United States, 10461
        • Recruiting
        • Montefiore Medical Center
    • North Carolina
      • Fayetteville, North Carolina, United States, 28303
        • Active, not recruiting
        • Carolina Institute for Clinical Research, LLC
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Recruiting
        • Cincinnati Children's Hospital Medical Center
      • Cincinnati, Ohio, United States, 45242
        • Active, not recruiting
        • Velocity Clinical Research
    • Oklahoma
      • Oklahoma City, Oklahoma, United States, 73112
        • Active, not recruiting
        • Lynn Health Science Institute
    • South Carolina
      • Charleston, South Carolina, United States, 29414
        • Active, not recruiting
        • Coastal Pediatric Research
      • Greenville, South Carolina, United States, 29607
        • Terminated
        • Tribe Clinical Research LLC
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Recruiting
        • Avera Research Institute
      • Sioux Falls, South Dakota, United States, 57105
        • Recruiting
        • Avera McKennan Hospital & University Health Center
      • Sioux Falls, South Dakota, United States, 57110
        • Recruiting
        • Avera Medical Group Pediatrics - Dawley Farm
    • Tennessee
      • Nashville, Tennessee, United States, 37232
        • Terminated
        • Monroe Carell Jr Children's Hospital at Vanderbilt
    • Texas
      • Dallas, Texas, United States, 75209
        • Recruiting
        • Alina Clinical Trials, LLC.
      • Frisco, Texas, United States, 75034
        • Recruiting
        • North Texas Center for Clinical Research
      • Houston, Texas, United States, 77094
        • Recruiting
        • NeuroCare Plus
      • Houston, Texas, United States, 77065
        • Recruiting
        • DM Clinical Research - Cy Fair
      • Houston, Texas, United States, 77077
        • Recruiting
        • SCLA Management - Drop Box
      • Houston, Texas, United States, 77077
        • Recruiting
        • SCLA Management Office
      • Lake Jackson, Texas, United States, 77566
        • Active, not recruiting
        • Red Star Research, LLC
      • McAllen, Texas, United States, 78503
        • Recruiting
        • DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials
      • San Antonio, Texas, United States, 78258
        • Recruiting
        • DCT-Stone Oak, LLC dba Discovery Clinical Trials
      • Sherman, Texas, United States, 75092
        • Active, not recruiting
        • Texas Institute for Neurological Disorders
      • Tomball, Texas, United States, 77375
        • Recruiting
        • DM Clinical Research (Administrative Office Only)
      • Victoria, Texas, United States, 77901
        • Terminated
        • Victoria Clinical Research Group
    • Virginia
      • Portsmouth, Virginia, United States, 23703
        • Active, not recruiting
        • Meridian Clinical Research, LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 17 years (Child)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:

    1. 14 or less headache days per month during the 3 month period prior to the Screening Visit
    2. 6 or more migraine days during the Observation Period
    3. 14 or less headache days during the Observation Period
    4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of >10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit
    5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
    6. Migraine attacks, on average, lasting 4 - 72 hours if untreated

    7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to <18 years; subjects must be less than 18 at the time of signing assent / consent.

      3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.

Exclusion Criteria:

  1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
  2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
  3. The subject has a history or diagnosis of complications of migraine
  4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
  5. The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded.
  6. History of suicidal behavior or the subject is at risk of self-harm or harm to others.
  7. History of major psychiatric disorder.
  8. The subject has a current diagnosis or history of substance abuse
  9. The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Rimegepant / BHV3000
Rimegepant 75mg or 50mg (2 X 25mg) ODT
Drug: Rimegepant
Rimegepant 75mg or 50mg (2 X 25mg) ODT
Other Names:
  • BHV3000
Placebo Comparator: Matching Placebo
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Drug: Placebo
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Other Names:
  • Matching Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine
Time Frame: 3 months (12 weeks)
Reduction from baseline in mean number of migraine days per month
3 months (12 weeks)

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Achievement of at least a 50% reduction from baseline in mean monthly migraine days over the course of the double-blind phase in adolescents with episodic migraine
Time Frame: 3 months (12 weeks)
3 months (12 weeks)
Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine.
Time Frame: Weeks 1 through 4 of treatment
Weeks 1 through 4 of treatment
The mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine.
Time Frame: Total score at week 12
Total score at week 12
Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
Time Frame: 3 months (12 weeks)
3 months (12 weeks)
Change from baseline on the proportion of subjects that have at least a 50% reduction in the mean number of moderate to severe migraine days per month.
Time Frame: 3 months (12 weeks)
Measured over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
3 months (12 weeks)
Compare the use of acute migraine-specific medications (triptans) based on the change from baseline in monthly acute migraine specific medication days.
Time Frame: 3 months (12 weeks)
Measured in each month and over the course of the entire double-blind treatment phase in adolescents, children and adolescents and children combined.
3 months (12 weeks)
Evaluate the safety and tolerability of rimegepant as a preventative treatment for migraine in children and adolescents.
Time Frame: 72 Weeks
This will be evaluated by the number of subjects with treatment related adverse events by severity.
72 Weeks
Evaluate the frequency of hepatic-related adverse events in subjects treated with rimegepant.
Time Frame: 72 Weeks
Measured by discontinuations in treated subjects due to elevated liver function tests.
72 Weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Pfizer

Collaborators

Biohaven Pharmaceutical Holding Company Ltd.

Investigators

  • Study Director: Pfizer CT.gov Call Center, Pfizer

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 28, 2022

Primary Completion (Estimated)

November 29, 2031

Study Completion (Estimated)

November 27, 2032

Study Registration Dates

First Submitted

November 19, 2021

First Submitted That Met QC Criteria

November 30, 2021

First Posted (Actual)

December 14, 2021

Study Record Updates

Last Update Posted (Actual)

June 5, 2026

Last Update Submitted That Met QC Criteria

June 4, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHV3000-315
  • C4951009 (Other Identifier: Alias Study Number)
  • 2021-005246-15 (Registry Identifier: CTIS (EU))
  • 2024-512382-13-00 (Registry Identifier: CTIS (EU))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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