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

Last updated: April 9, 2025
Sponsor: Pfizer
Overall Status: Active - Recruiting

Phase

3

Condition

Pain (Pediatric)

Oral Facial Pain

Headaches

Treatment

Placebo

Rimegepant

Clinical Study ID

NCT05156398
BHV3000-315
2021-005246-15
C4951009
2024-512382-13-00
  • Ages 6-17
  • All Genders

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

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

  2. 14 or less headache days per month during the 3 month period prior to theScreening Visit

  3. 6 or more migraine days during the Observation Period

  4. 14 or less headache days during the Observation Period

  5. 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

  6. Ability to verbally distinguish migraine attacks from tension/cluster or othertypes of headaches

  7. Migraine attacks, on average, lasting 4 - 72 hours if untreated

  8. Subjects on prophylactic migraine medication are permitted to remain on therapyif the dose has been stable for at least 3 months (12 weeks) prior to theScreening Phase, and the dose is not expected to change during the course ofthe study. 2) Male and female subjects ≥ 6 to <18 years; subjects must be lessthan 18 at the time of signing assent / consent. 3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) atthe Screening Visit.

Exclusion

Exclusion Criteria:

  1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegicmigraine

  2. The subject has a continuous migraine (defined as an unrelenting headache) within 1month 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 mayinterfere with the subject's ability to participate in this study.

  5. The subject has any current psychiatric condition that is uncontrolled and/oruntreated for a minimum of 6 months prior to the Screening Visit. Subjects with alifetime history of psychosis and/or mania are excluded.

  6. History of suicidal behavior or the subject is at risk of self-harm or harm toothers.

  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 neurologicaldisorder (including seizure disorder) or systemic medical disease that is, in theinvestigator's opinion, likely to affect central nervous system functioning.

Study Design

Total Participants: 640
Treatment Group(s): 2
Primary Treatment: Placebo
Phase: 3
Study Start date:
February 28, 2022
Estimated Completion Date:
November 27, 2032

Connect with a study center

  • Children's and Women's Health Centre of British Columbia

    Vancouver, British Columbia V6H 3V4
    Canada

    Site Not Available

  • The Kids Clinic

    Ajax, Ontario L1Z 0M1
    Canada

    Active - Recruiting

  • The Kids Clinic Inc

    Ajax, Ontario L1Z0M1
    Canada

    Site Not Available

  • Children's Hospital of Eastern Ontario

    Ottawa, Ontario K1H 8L1
    Canada

    Site Not Available

  • Centre Hospitalier Intercommunal de Créteil

    Créteil, 94000
    France

    Site Not Available

  • CHU Gui de Chauliac

    Montpellier, 34090
    France

    Site Not Available

  • Centre Hospitalier Universitaire de Montpellier

    Montpellier, 34295
    France

    Active - Recruiting

  • Hopital des Enfants

    Toulouse, 31059
    France

    Active - Recruiting

  • Unita di Neurologia, Azienda Ospedaliera San Giuseppe Moscati

    Avellino, Avellino/campania 83100
    Italy

    Active - Recruiting

  • UOSVD Centro Epilessia ed EEG dellEta Evolutiva

    Bari, BARI / Puglia 70132
    Italy

    Site Not Available

  • Spedali Civili di Brescia

    Brescia, Brescia/lombardy 25123
    Italy

    Active - Recruiting

  • Azienda Ospedaliero Universitaria Meyer

    Firenze, Florence 50139
    Italy

    Site Not Available

  • Azienda Ospedaliero Universitaria Meyer

    Florence, Florence/tuscany 50139
    Italy

    Active - Recruiting

  • Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic

    Latina, Latina/lazio 04100
    Italy

    Active - Recruiting

  • Spaienza Universita di Roma Polo Pontino - ICOT, Headache clinic

    Latina, Latina/lazio 04100
    Italy

    Site Not Available

  • IRCCS San Raffaele

    Roma, Lazio 00166
    Italy

    Active - Recruiting

  • Ospedale Pediatrico Bambino Gesu

    Roma, Lazio 00165
    Italy

    Active - Recruiting

  • Istituto Neurologico "Carlo Besta" Fondazione IRCCS

    Milano, Lombardia 20133
    Italy

    Site Not Available

  • U.O. Neuropsichiatria Infantile, IRCCS Fondazione Mondino

    Pavia, Lombardia 27100
    Italy

    Site Not Available

  • U.O. di Neurologia- ASST Spedali Civili di Brescia

    Brescia, Lombardy 25069
    Italy

    Site Not Available

  • SS Centro Cefalee - UOC di Neurologia 3

    Milan, Milan/lombardy 20133
    Italy

    Site Not Available

  • Fondazione Mondino - Istituto Neurologico Nazionale IRCCS

    Pavia, Padua 27100
    Italy

    Site Not Available

  • IRCCS San Raffaele

    Rome, ROME / Latium 00163
    Italy

    Site Not Available

  • Divisione di Neurologia, Ospedale Pediatrico Bambino Gesu

    Rome, Rome/lazio 00165
    Italy

    Site Not Available

  • Presidio Ospedaliero San Paolo

    Bari, 70132
    Italy

    Site Not Available

  • Istituto neurologico Carlo Besta

    Milano, 20133
    Italy

    Site Not Available

  • Dipartimento Materno Infantile e Scienze UroGinecologiche - UOC Pediatria

    Roma, 00161
    Italy

    Active - Recruiting

  • IRCCS San Raffaele Roma

    Rome, 00197
    Italy

    Site Not Available

  • Medical Corporation Seikokai Takanoko Hospital

    Matsuyama-shi, Ehime 790-0925
    Japan

    Site Not Available

  • Jinnouchi Neurosurgical Clinic

    Kasuga-shi, Fukuoka 816-0802
    Japan

    Active - Recruiting

  • Hikita Pediatric Clinic

    Kiryu-shi, Gunma 376-0035
    Japan

    Site Not Available

  • Hiroshima City Hiroshima Citizens Hospital

    Naka-ku Hiroshima-shi, Hiroshima 730-8518
    Japan

    Site Not Available

  • Konan Medical Center

    Higashinada-ku Kobe-shi, Hyōgo 658-0064
    Japan

    Site Not Available

  • Yamaguchi Clinic

    Nishinomiya-shi, Hyōgo 663-8204
    Japan

    Active - Recruiting

  • Mito Kyodo General Hospital

    Mito-shi, Ibaraki 310-0015
    Japan

    Site Not Available

  • Tanaka Neurosurgery & Headache Clinic

    Kagoshima-city, Kagoshima 890-0052
    Japan

    Active - Recruiting

  • Tanaka Neurosurgical Clinic

    Kagoshima-shi, Kagoshima 892-0844
    Japan

    Site Not Available

  • Atago Hospital

    Kochi-shi, Kōchi 780-0051
    Japan

    Active - Recruiting

  • Sendai Headache and Neurology Clinic

    Taihaku-ku Sendai-shi, Miyagi 982-0014
    Japan

    Active - Recruiting

  • Tennouji Dai Brain Clinic

    Abeno-ku Osaka-shi, Osaka 545-0053
    Japan

    Active - Recruiting

  • Tominaga Clinic

    Naniwa-ku, Osaka 556-0015
    Japan

    Active - Recruiting

  • Tominaga Clinic

    Naniwa-ku, Osaka-shi, Osaka 556-0015
    Japan

    Site Not Available

  • Saitama Neuropsychiatric Institute

    Chuo-ku Saitama-shi, Saitama 338-8577
    Japan

    Active - Recruiting

  • Tokyo Headache Clinic

    Shibuya-ku, Tokyo 151-0051
    Japan

    Active - Recruiting

  • Tokyo Medical University Hospital

    Shinjuku-ku, Tokyo 160-0023
    Japan

    Site Not Available

  • Tokyo Medical University Hospital

    Shinjyuku-ku, Tokyo 160-0023
    Japan

    Site Not Available

  • LIAC Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital

    Hiroshima, 730-8518
    Japan

    Site Not Available

  • MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

    Wroclaw, Dolnoslaskie 52-210
    Poland

    Active - Recruiting

  • Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej

    Lublin, Lubelskie 20-582
    Poland

    Site Not Available

  • NZOZ Neuromed M. i M. Nastaj Sp. P.

    Lublin, Lubelskie 20-064
    Poland

    Active - Recruiting

  • Wojewodzki Specjalistyczny Szpital Dzieciecy

    Krakow, Malopolskie 31-503
    Poland

    Active - Recruiting

  • MTZ Clinical Research Powered by Pratia

    Warszawa, Mazowieckie 02-172
    Poland

    Active - Recruiting

  • Next Stage Sp. Z o.o.

    Warszawa, Mazowieckie 02-121
    Poland

    Active - Recruiting

  • NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

    Katowice, Slaskie 40-123
    Poland

    Site Not Available

  • Neurologia Slaska Centrum Medyczne

    Katowice, Slaskie 40-689
    Poland

    Active - Recruiting

  • Next Stage Sp. Z o.o.

    Warsaw, WOJ. Mazowieckie 02-121
    Poland

    Active - Recruiting

  • Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.

    Poznan, Wielkopolskie 61-731
    Poland

    Active - Recruiting

  • Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie

    Krakow, 31-503
    Poland

    Site Not Available

  • MTZ Clinical Research Sp. z o.o.

    Warszawa, 02-106
    Poland

    Active - Recruiting

  • Hospital Universitari Parc Tauli

    Sabadell, Barcelona 08208
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Valladolid (HCUV)

    Valladolid, Castilla Y LEON 47003
    Spain

    Active - Recruiting

  • Hospital Alvaro Cunqueiro

    Vigo, Galicia 36312
    Spain

    Active - Recruiting

  • Hospital Clinico Universitario de Santiago de Compostela

    Santiago de Compostela, LA Coruna 15706
    Spain

    Site Not Available

  • Hospital Universitari Parc Taulí Institut d'Investigació i Innovació Parc Taulí

    Barcelona, 08208
    Spain

    Site Not Available

  • Instituto de Investigaciones del Sueno

    Madrid, 28036
    Spain

    Site Not Available

  • Virgen del Rocio Hospital

    Sevilla, 41013
    Spain

    Active - Recruiting

  • Hospital Universitario y Politecnico La Fe

    Valencia, 46026
    Spain

    Active - Recruiting

  • The Belinga Clinic

    Fort Smith, Arkansas 72901
    United States

    Site Not Available

  • Advanced Investigative Medicine, Inc.

    Hawthorne, California 90250
    United States

    Active - Recruiting

  • Velocity Clinical Research San Diego

    La Mesa, California 91942
    United States

    Site Not Available

  • Palo Alto Medical Foundation

    Palo Alto, California 94301
    United States

    Site Not Available

  • Care Access

    Pasadena, California 91101
    United States

    Site Not Available

  • Clinical Research of California

    Walnut Creek, California 94598
    United States

    Site Not Available

  • Colorado Springs Neurological Associates

    Colorado Springs, Colorado 80907
    United States

    Active - Recruiting

  • Advanced Neurosciences Research, LLC

    Fort Collins, Colorado 80528
    United States

    Active - Recruiting

  • Hasbani Neurology

    New Haven, Connecticut 06511
    United States

    Site Not Available

  • Meridian Clinical Research, LLC

    Washington, District of Columbia 20016
    United States

    Active - Recruiting

  • Synergy Healthcare

    Bradenton, Florida 34209
    United States

    Active - Recruiting

  • Vertex Research Group

    Clermont, Florida 34711
    United States

    Site Not Available

  • Accel Research Sites Network - Edgewater Clinical Research Unit

    Edgewater, Florida 32132
    United States

    Site Not Available

  • Complete Health Research

    Edgewater, Florida 32132
    United States

    Active - Recruiting

  • Direct Helpers Research Center

    Hialeah, Florida 33012
    United States

    Active - Recruiting

  • New Med Research, Inc

    Hollywood, Florida 33020
    United States

    Terminated

  • Axcess Medical Research

    Loxahatchee Groves, Florida 33470
    United States

    Site Not Available

  • Sanitas Research, LLC

    Miami, Florida 33155
    United States

    Site Not Available

  • APG Research, LLC

    Orlando, Florida 32803
    United States

    Site Not Available

  • Complete Health Research

    Ormond Beach, Florida 32174
    United States

    Site Not Available

  • D&H Tamarac Research Center LLC

    Tamarac, Florida 33321
    United States

    Active - Recruiting

  • Santos Research Center

    Tampa, Florida 33615
    United States

    Site Not Available

  • Santos Research Center, CORP

    Tampa, Florida 33615
    United States

    Active - Recruiting

  • Augusta University

    Augusta, Georgia 30912
    United States

    Active - Recruiting

  • WR-Mount Vernon Clinical Research, LLC

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Meridian Clinical Research, LLC

    Savannah, Georgia 31406
    United States

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  • Extraordinary Family Healthcare

    Snellville, Georgia 30078
    United States

    Site Not Available

  • Renew Health Clinical Research LLC

    Snellville, Georgia 30078
    United States

    Site Not Available

  • Northwest Clinical Trials, Inc.

    Boise, Idaho 83704
    United States

    Active - Recruiting

  • Diamond Headache Clinic

    Chicago, Illinois 60642
    United States

    Terminated

  • Research Works INC

    New Orleans, Louisiana 70125
    United States

    Site Not Available

  • Clinical Research Institute

    Minneapolis, Minnesota 55402
    United States

    Site Not Available

  • Safe Haven Clinical Research

    Clinton, Mississippi 39056
    United States

    Active - Recruiting

  • Safe Haven Clinical Research

    Natchez, Mississippi 39120
    United States

    Site Not Available

  • Safe Haven Clinical Research,Inc.

    Clinton, Missouri 39056
    United States

    Site Not Available

  • MU Child Health

    Columbia, Missouri 65201
    United States

    Site Not Available

  • University of Missouri

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • University of Missouri - Investigational Pharmacy

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • University of Missouri Health Care - Clinical Research Center

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • University of Missouri Health Care - Investigation Pharmacy (IP to be shipped here)

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • University of Missouri Health Care - Pathology Department

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • University of Missouri School of Medicine

    Columbia, Missouri 65212
    United States

    Active - Recruiting

  • AMR Kansas City

    Kansas City, Missouri 64114
    United States

    Site Not Available

  • Velocity Clinical Research, Inc.

    Grand Island, Nebraska 68803
    United States

    Active - Recruiting

  • Meridian Clinical Research, LLC

    Hastings, Nebraska 68901
    United States

    Active - Recruiting

  • Velocity Clinical Research, Inc.

    Hastings, Nebraska 68901
    United States

    Site Not Available

  • Midwest Children's Health Research Institute, LLC

    Lincoln, Nebraska 68504
    United States

    Site Not Available

  • CCT Research

    Papillion, Nebraska 68046
    United States

    Site Not Available

  • Papillion Research Center/CCT Research

    Papillion, Nebraska 68046
    United States

    Active - Recruiting

  • Renown Regional Medical Center

    Reno, Nevada 89502
    United States

    Site Not Available

  • Ocean Medical Research

    Toms River, New Jersey 08755
    United States

    Site Not Available

  • Albuquerque Neuroscience Inc.

    Albuquerque, New Mexico 87109
    United States

    Site Not Available

  • Dent Neurosciences Research Center, Inc.

    Amherst, New York 14226
    United States

    Active - Recruiting

  • Montefiore Medical Center

    Bronx, New York 10461
    United States

    Active - Recruiting

  • Rochester Clinical Research, Inc.

    Rochester, New York 14609
    United States

    Site Not Available

  • CICR

    Fayetteville, North Carolina 28303
    United States

    Site Not Available

  • Carolina Institute for Clinical Research, LLC

    Fayetteville, North Carolina 28303
    United States

    Site Not Available

  • Trinity Health

    Minot, North Dakota 58701
    United States

    Site Not Available

  • Cincinnati Children's Hospital Medical Center

    Cincinnati, Ohio 45229
    United States

    Active - Recruiting

  • Velocity Clinical Research

    Cincinnati, Ohio 45242
    United States

    Site Not Available

  • Optimed Research

    Columbus, Ohio 43235
    United States

    Site Not Available

  • Lynn Health Science Institute

    Oklahoma City, Oklahoma 73112
    United States

    Site Not Available

  • Coastal Pediatric Research

    Charleston, South Carolina 29414
    United States

    Site Not Available

  • Meridian Clinical Research, LLC

    Charleston, South Carolina 29407
    United States

    Active - Recruiting

  • Tribe Clinical Research LLC

    Greenville, South Carolina 29607
    United States

    Site Not Available

  • Tribe Clinical Research

    Spartanburg, South Carolina 29301
    United States

    Site Not Available

  • Avera McKennan Hospital & University Health Center

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • Avera McKennan d/b/a Avera Research Institute

    Sioux Falls, South Dakota 57108
    United States

    Site Not Available

  • Avera Medical Group Pediatric Specialists

    Sioux Falls, South Dakota 57105
    United States

    Active - Recruiting

  • Avera Research Institute

    Sioux Falls, South Dakota 57108
    United States

    Active - Recruiting

  • Monroe Carell Jr Children's Hospital at Vanderbilt

    Nashville, Tennessee 37232
    United States

    Active - Recruiting

  • TIND

    Arlington, Texas 76015
    United States

    Site Not Available

  • Alina Clinical Trials, LLC Barbara Baxter, Sole MBR

    Dallas, Texas 75225
    United States

    Site Not Available

  • Alina Clinical Trials, LLC.

    Dallas, Texas 75209
    United States

    Active - Recruiting

  • DCT-Baxter Research, LLC dba Discovery Clinical Trials

    Dallas, Texas 75225
    United States

    Active - Recruiting

  • North Texas Center for Clinical Research

    Frisco, Texas 75034
    United States

    Active - Recruiting

  • DM Clinical Research - Cy Fair

    Houston, Texas 77065
    United States

    Active - Recruiting

  • NeuroCare Plus

    Houston, Texas 77094
    United States

    Active - Recruiting

  • SCLA Management

    Houston, Texas 77079
    United States

    Active - Recruiting

  • SCLA Management - Drop Box

    Houston, Texas 77077
    United States

    Active - Recruiting

  • SCLA Management Office

    Houston, Texas 77077
    United States

    Active - Recruiting

  • Red Star Research, LLC

    Lake Jackson, Texas 77566
    United States

    Active - Recruiting

  • FMC Science

    Lampasas, Texas 76550
    United States

    Site Not Available

  • DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials

    McAllen, Texas 78503
    United States

    Active - Recruiting

  • DCT-Baxter Research, LLC dba Discovery Clinical Trials

    San Antonio, Texas 78230
    United States

    Site Not Available

  • DCT-Stone Oak, LLC dba Discovery Clinical Trials

    San Antonio, Texas 78258
    United States

    Active - Recruiting

  • Texas Institute for Neurological Disorders

    Sherman, Texas 75092
    United States

    Active - Recruiting

  • DM Clinical Research (Administrative Office Only)

    Tomball, Texas 77375
    United States

    Active - Recruiting

  • Victoria Clinical Research Group

    Victoria, Texas 77901
    United States

    Active - Recruiting

  • South Ogden Family Medicine

    South Ogden, Utah 84405
    United States

    Site Not Available

  • South Ogden Family Medicine Ogden Clinic/CCT Research

    South Ogden, Utah 84405
    United States

    Active - Recruiting

  • Meridian Clinical Research, LLC

    Portsmouth, Virginia 23703
    United States

    Site Not Available

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