A Study to Learn About the Study Medicine Called Rimegepant in Adolescents With Frequent Migraine

July 29, 2026 updated by: Pfizer

AN INTERVENTIONAL, EFFICACY, AND SAFETY, PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY WITH AN OPEN-LABEL EXTENSION TO INVESTIGATE RIMEGEPANT IN MIGRAINE PREVENTION IN ADOLESCENTS 12 TO LESS THAN 18 YEARS OF AGE WITH CHRONIC MIGRAINE

The purpose of this study is to learn about the effect of a study medicine called rimegepant in adolescents who have frequent migraine attacks.

Rimegepant is a tablet that dissolves when you put it on or under your tongue.

The study will enroll participants who have headache for 15 days (or more) every month, of which 8 days (or more) of migraine every month, and each untreated attack lasts for an average of 4-72 hours

In the 1st part of the study approximately half of the participants will receive a rimegepant tablet every other day, and approximately half of the participants will receive an inactive oral tablet (that looks the same as the rimegepant tablet) every other day.

Participant experiences when they are taking the study medicine will be compared to when they are taking the inactive tablet. This will help to determine if the study medicine is safe and effective. The 1st phase of the study will last 3 months.

In the 2nd part of the study all the participants who stay on study will receive rimegepant tablet every other day. This 2nd phase of the study will last 1 year. This will help determine if the study medicine is safe when taken for a long period.

Those who will participate in both phases will have up to 19 visits at the study clinic, about one every 4 weeks (this may vary from 2 to 8 weeks interval during the study). Home health visits may occur as well. A health check and blood sample will be conducted at all visits. Participants will have to complete a daily diary to record the migraine attacks.

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

200

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 Locations

  • Canada
    • Alberta
      • Edmonton, Alberta, Canada, T6G 2B7
        • Stollery Children's Hospital
      • Edmonton, Alberta, Canada, T6G 1W9
        • University of Alberta Hospital
      • Red Deer, Alberta, Canada, T4P 1K4
        • CaRe Clinic
    • Ontario
      • London, Ontario, Canada, N6A 5W9
        • London Health Sciences Centre - Verspeeten Family Cancer Centre
  • China
      • Hefei, China, 230001
        • Anhui Provincial Hospital
      • Shanghai, China, 200062
        • Shanghai Children's Hospital
      • Shijiazhuang, China
        • The Second Affiliated Hospital of Hebei Medical University
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Peking University People's Hospital
    • Chongqing Municipality
      • Chongqing, Chongqing Municipality, China, 400016
        • The First Affiliated Hospital of Chongqing Medical University
    • Guangdong
      • Guangzhou, Guangdong, China, 510180
        • Guangzhou First People's Hospital
    • Hubei
      • Jingzhou, Hubei, China, 434000
        • Jingzhou First People's Hospital
      • Wuhan, Hubei, China, 430010
        • Wuhan Children's Hospital
    • Hunan
      • Changsha, Hunan, China, 410013
        • The Third XIANGYA Hospital of Central South University
      • Changsha, Hunan, China, 410011
        • The Second Xiangya Hospital of Central South University
    • Jiangsu
      • Suzhou, Jiangsu, China, 215006
        • The First Affiliated Hospital of Soochow University
      • Wuxi, Jiangsu, China, 214023
        • Wuxi Children's Hospital
      • Zhenjiang, Jiangsu, China, 212001
        • Affiliated Hospital of Jiangsu University
    • Ningxia
      • Yinchuan, Ningxia, China, 750004
        • General Hospital of Ningxia Medical University
  • Czechia
      • Prague, Czechia, 150 06
        • Fakultní nemocnice Motol a Homolka
    • Brno-město
      • Brno, Brno-město, Czechia, 613 00
        • Detska nemocnice FN Brno
    • Hradec Králové
      • Hradec Králové, Hradec Králové, Czechia, 500 05
        • Fakultni nemocnice Hradec Kralove
    • Moravian-Silesian Region
      • Ostrava, Moravian-Silesian Region, Czechia, 708 52
        • Fakultni Nemocnice Ostrava
    • Praha 4
      • Prague, Praha 4, Czechia, 14059
        • Fakultni Thomayerova nemocnice
  • Finland
      • Helsinki, Finland, 00280
        • Clinical Research Institute Helsinki University Central Hospital Ltd
      • Helsinki, Finland, 00290
        • New Children's Hospital
      • Tampere, Finland, 33100
        • Terveystalo Tampere
      • Turku, Finland, 20100
        • Terveystalo Pulssi
    • North Ostrobothnia
      • Oulu, North Ostrobothnia, Finland, 90100
        • Terveystalo Oulu
    • Northern Savonia
      • Kuopio, Northern Savonia, Finland, 70210
        • Kuopion Yliopistollinen Sairaala
    • Pirkanmaa
      • Tampere, Pirkanmaa, Finland, 33520
        • Tampereen yliopistollinen sairaala
    • Southwest Finland
      • Turku, Southwest Finland, Finland, 20520
        • Turku University Hospital
  • Hungary
      • Budapest, Hungary, 1083
        • Semmelweis Egyetem
      • Budapest, Hungary, 1094
        • Semmelweis Egyetem
    • Nógrád megye
      • Balassagyarmat, Nógrád megye, Hungary, 2660
        • Dr. Kenessey Albert Kórház
    • Zala County
      • Nagykanizsa, Zala County, Hungary, 8800
        • Nagykanizsai Kanizsai Dorottya Korhaz
  • India
    • Haryana
      • Gurugram, Haryana, India, 122001
        • Artemis Hospital
    • Karnataka
      • Mangalore, Karnataka, India, 575002
        • Mallikatta Neuro Centre
    • Maharashtra
      • Nashik, Maharashtra, India, 422005
        • Chopda Medicare & Research Centre Pvt. Ltd; Magnum Heart Institute
    • National Capital Territory of Delhi
      • New Delhi, National Capital Territory of Delhi, India, 110060
        • Sir Ganga Ram Hospital
      • New Delhi, National Capital Territory of Delhi, India, 110029
        • All India Institute of Medical Sciences
  • Italy
      • Brescia, Italy, 25123
        • ASST Spedali Civili di Brescia
      • Latina, Italy, 04100
        • I.C.O.T. Università La Sapienza
      • Pavia, Italy, 27100
        • Fondazione Istituto Neurologico C. Mondino
      • Roma, Italy, 00166
        • IRCCS San Raffaele Roma
    • Abruzzo
      • L’Aquila, Abruzzo, Italy, 67100
        • ASL1 Avezzano-Sulmona-L'Aquila
    • Apulia
      • Bari, Apulia, Italy, 70132
        • Ospedale San Paolo Bari
    • Lombardy
      • Milan, Lombardy, Italy, 20133
        • IRCCS Istituto Neurologico Carlo Besta
    • ROMA
      • Rome, ROMA, Italy, 00163
        • IRCCS San Raffaele Roma
  • Japan
      • Kagoshima, Japan, 890-0052
        • Tanaka Neurosurgery&Headache Clinic
      • Osaka, Japan, 545-0053
        • Tennoji Department of Neurosurgery
    • Hyōgo
      • Kobe, Hyōgo, Japan, 658-0064
        • Konan Medical Center
      • Nishinomiya, Hyōgo, Japan, 663-8204
        • Yamaguchi Clinic
    • Osaka
      • Osaka, Osaka, Japan, 556-0015
        • Tominaga Clinic
    • Tokyo
      • Shibuya-ku, Tokyo, Japan, 151-0051
        • Tokyo Headache Clinic
    • Yamanashi
      • Kai, Yamanashi, Japan, 400-0124
        • Nagaseki Headache Clinic
  • Poland
      • Lublin, Poland, 20-064
        • NZOZ Neuromed M. i M. Nastaj Sp. P.
    • Kuyavian-Pomeranian Voivodeship
      • Bydgoszcz, Kuyavian-Pomeranian Voivodeship, Poland, 85-752
        • AthleticoMed
    • Lesser Poland Voivodeship
      • Krakow, Lesser Poland Voivodeship, Poland, 30-539
        • Specjalistyczne Gabinety Sp. z o.o.
    • Lower Silesian Voivodeship
      • Wroclaw, Lower Silesian Voivodeship, Poland, 52-210
        • MIGRE Polskie Centrum Leczenia Migreny
      • Wroclaw, Lower Silesian Voivodeship, Poland, 53-025
        • MedicArt Sp. z o. o.
    • Lublin Voivodeship
      • Lublin, Lublin Voivodeship, Poland, 20-701
        • Centrum Medyczne Hope Clinic Sebastian Szklener
    • Masovian Voivodeship
      • Warsaw, Masovian Voivodeship, Poland, 04-501
        • Medical Network Spółka z o.o. WIP Warsaw IBD Point Profesor Kierkuś
      • Warsaw, Masovian Voivodeship, Poland, 01-018
        • Dr Sękowska Leczenie Bólu
      • Warsaw, Masovian Voivodeship, Poland, 02-829
        • Neurosphera
  • Slovakia
      • Banská Bystrica, Slovakia, 97409
        • Detska fakultna nemocnica s poliklinikou Banska Bystrica
      • Bardejov, Slovakia
        • IN MEDIC s.r.o.
      • Dubnica nad Váhom, Slovakia
        • KONZILIUM s.r.o.
      • Martin, Slovakia, 036 59
        • Univerzitna Nemocnica Martin
  • Spain
      • Madrid, Spain, 28050
        • Hospital Universitario HM Sanchinarro
      • Seville, Spain, 41013
        • Hospital Universitario Virgen del Rocío
      • Valencia, Spain, 46026
        • Hospital Universitari i Politecnic La Fe
      • Valladolid, Spain, 47005
        • Hospital Clínico Universitario de Valladolid
    • Barcelona [barcelona]
      • Barcelona, Barcelona [barcelona], Spain, 08035
        • Hospital Universitari Vall d'Hebron
    • Madrid, Comunidad de
      • Madrid, Madrid, Comunidad de, Spain, 28938
        • Hospital Universitario HM Puerta del Sur
    • Pontevedra
      • Vigo, Pontevedra, Spain, 36213
        • CHUVI- Hospital Alvaro Cunqueiro
  • United States
    • Arizona
      • Phoenix, Arizona, United States, 85004
        • Xenoscience Inc
    • California
      • Long Beach, California, United States, 90806
        • Adult & Child Neurology Medical Associates
    • Colorado
      • Aurora, Colorado, United States, 80045
        • Children's Hospital Colorado
    • Illinois
      • Chicago, Illinois, United States, 60611
        • Ann & Robert H. Lurie Children's Hospital of Chicago
      • Chicago, Illinois, United States, 60657
        • Chicago Headache Center and Research Institute
      • Naperville, Illinois, United States, 60563
        • Chicago Headache Center and Research Institute
    • Massachusetts
      • Worcester, Massachusetts, United States, 01609
        • New England Regional Headache Center
    • Michigan
      • Ann Arbor, Michigan, United States, 48104
        • Michigan Headache & Neurological Institute
    • Missouri
      • Springfield, Missouri, United States, 65807
        • Clinvest Headlands Llc
    • New Jersey
      • New Brunswick, New Jersey, United States, 08901
        • Rutgers University
    • North Carolina
      • Charlotte, North Carolina, United States, 28211
        • Onsite Clinical Solutions
      • Durham, North Carolina, United States, 27703
        • Duke Health Center Creekstone
      • Durham, North Carolina, United States, 27705
        • Duke Lenox Baker Children's
      • Durham, North Carolina, United States, 27710
        • Duke Children's Health Center
      • Winston-Salem, North Carolina, United States, 27157
        • Wake Forest University Baptist Medical Center ( WFUBMC )
    • Ohio
      • Cincinnati, Ohio, United States, 45229
        • Cincinnati Children's Hospital Medical Center
      • Cleveland, Ohio, United States, 44195
        • Cleveland Clinic
    • Pennsylvania
      • Pittsburgh, Pennsylvania, United States, 15224
        • UPMC Children's Hospital of Pittsburgh
    • South Dakota
      • Sioux Falls, South Dakota, United States, 57108
        • Avera Research Institute - Sioux Falls
      • Sioux Falls, South Dakota, United States, 57105
        • Avera Medical Group Pediatric Specialists
      • Sioux Falls, South Dakota, United States, 57110
        • Avera Medical Group Pediatrics - Dawley Farm
    • Texas
      • Austin, Texas, United States, 78723
        • Dell Children's Medical Center
      • El Paso, Texas, United States, 79902
        • Headlands Research-El Paso
      • Houston, Texas, United States, 77030
        • The University of Texas Health Science Center at Houston
    • Utah
      • Salt Lake City, Utah, United States, 84107
        • Wasatch Clinical Research, LLC
      • Salt Lake City, Utah, United States, 84117
        • Granger Medical Holladay - Holladay Clinic
    • Washington
      • Seattle, Washington, United States, 98105
        • Seattle Children's Hospital

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

  • Child

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • At least a 6 month history of migraine (with or without aura)
  • 15 or more headache days/month
  • 8 or more migraine days/month
  • Migraine lasting 4-72 hours if untreated

Exclusion Criteria:

  • Unrelenting headache
  • Current psychiatric condition uncontrolled or untreated
  • History of suicidal behavior or the subject is at risk of self-harm
  • History of alcohol abuse and/or illicit drug use
  • History of severe drug allergy
  • Use of more than one medication for migraine prevention/prophylaxis
  • Participation in another clinical trial at the same time

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: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Rimegepant
Experimental medicine under study
Drug: Rimegepant
Rimegepant 75 mg orally disintegrating tablets
Placebo Comparator: Placebo
A placebo does not have any medicine in it but looks just like the medicine being studied.
Drug: Placebo
Matching placebo oral disintegrating tablets

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of migraine days per month
Time Frame: 12 Weeks
Efficacy of rimegepant relative to placebo, measured as mean change from the baseline in the number of migraine days per month
12 Weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the number of acute migraine-specific medication days per month
Time Frame: 12 Weeks
Change in the use of acute migraine-specific medication days per month
12 Weeks
Efficacy of rimegepant relative to placebo measured the mean change from baseline in the number of headache days per month
Time Frame: 12 Weeks
Change in headache days per month
12 Weeks
Efficacy of rimegepant relative to placebo measured as the percentage of participants with at least 50% reduction from baseline in number of moderate or severe migraine days per month
Time Frame: 12 weeks
Change in moderate or severe migraine days per month
12 weeks
Efficacy of rimegepant relative to placebo measured as the mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score
Time Frame: 12 Weeks
Change in the Quality of Life
12 Weeks
Efficacy of rimegepant relative to placebo measure as the mean change from baseline in the number of acute headache medication days per month, and acute migraine-specific medication days per month
Time Frame: 12 Weeks
Change in headache and migraine rescue medication(s) used
12 Weeks
Safety of rimegepant relative to placebo, and safety of rimegepant given for a long period of time measured as the number and percentage of participants with adverse event by severity and overall
Time Frame: Up to 15 months
Safety and tolerability of the study drug
Up to 15 months
Safety of rimegepant relative to placebo, and safety of rimegepant given for long period of time measured as the number and percentage of participants with liver-related adverse event and action taken
Time Frame: Up to 15 Months
Safety monitoring of adverse events of special interest
Up to 15 Months
Efficacy of rimegepant relative to placebo measured as mean change from baseline in the PedMIDAS total score
Time Frame: 12 Weeks
Change in the Quality of Life
12 Weeks

Collaborators and Investigators

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

Sponsor

Pfizer

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)

November 15, 2024

Primary Completion (Estimated)

August 19, 2028

Study Completion (Estimated)

October 13, 2029

Study Registration Dates

First Submitted

September 24, 2024

First Submitted That Met QC Criteria

September 24, 2024

First Posted (Actual)

September 27, 2024

Study Record Updates

Last Update Posted (Actual)

July 30, 2026

Last Update Submitted That Met QC Criteria

July 29, 2026

Last Verified

July 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • C4951013 (Alias Study Number)
  • BHV3000-320 (Other Identifier: Alias Study Number)
  • 2023-505601-16-00 (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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