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RECRUITING
NCT05156398
PHASE3

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

Sponsor: Pfizer

View on ClinicalTrials.gov

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.

Official title: 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

Key Details

Gender

All

Age Range

6 Years - 17 Years

Study Type

INTERVENTIONAL

Enrollment

640

Start Date

2022-02-28

Completion Date

2032-11-27

Last Updated

2026-03-20

Healthy Volunteers

No

Conditions

Interventions

DRUG

Rimegepant

Rimegepant 75mg or 50mg (2 X 25mg) ODT

DRUG

Placebo

Matching placebo 75mg or 50mg (2 X 25mg) ODT

Locations (90)

The Belinga Clinic

Fort Smith, Arkansas, United States

Advanced Investigative Medicine, Inc.

Hawthorne, California, United States

Velocity Clinical Research San Diego

La Mesa, California, United States

Colorado Springs Neurological Associates

Colorado Springs, Colorado, United States

Advanced Neurosciences Research, LLC

Fort Collins, Colorado, United States

Meridian Clinical Research, LLC

Washington D.C., District of Columbia, United States

Accel Research Sites Network - Edgewater Clinical Research Unit

Edgewater, Florida, United States

Direct Helpers Research Center

Hialeah, Florida, United States

New Med Research, Inc

Hollywood, Florida, United States

Complete Health Research

Ormond Beach, Florida, United States

D&H Tamarac Research Center LLC

Tamarac, Florida, United States

Santos Research Center, CORP

Tampa, Florida, United States

Augusta University

Augusta, Georgia, United States

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia, United States

Meridian Clinical Research, LLC

Savannah, Georgia, United States

Extraordinary Family Healthcare

Snellville, Georgia, United States

Renew Health Clinical Research LLC

Snellville, Georgia, United States

Northwest Clinical Trials, Inc.

Boise, Idaho, United States

Diamond Headache Clinic

Chicago, Illinois, United States

Nola Research Works, LLC

New Orleans, Louisiana, United States

Safe Haven Clinical Research

Clinton, Mississippi, United States

Roy Blunt NextGen Precision Health Building

Columbia, Missouri, United States

University of Missouri Health Care - Investigation Pharmacy

Columbia, Missouri, United States

University of Missouri-Clinical and Translational Sciences Unit

Columbia, Missouri, United States

Velocity Clinical Research, Grand Island

Grand Island, Nebraska, United States

Papillion Research Center/CCT Research

Papillion, Nebraska, United States

Renown Regional Medical Center

Reno, Nevada, United States

Dent Neurosciences Research Center, Inc.

Amherst, New York, United States

Montefiore Medical Center

The Bronx, New York, United States

Carolina Institute for Clinical Research, LLC

Fayetteville, North Carolina, United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio, United States

Velocity Clinical Research

Cincinnati, Ohio, United States

Lynn Health Science Institute

Oklahoma City, Oklahoma, United States

Coastal Pediatric Research

Charleston, South Carolina, United States

Tribe Clinical Research LLC

Greenville, South Carolina, United States

Avera McKennan Hospital & University Health Center

Sioux Falls, South Dakota, United States

Avera Research Institute

Sioux Falls, South Dakota, United States

Avera Medical Group Pediatrics - Dawley Farm

Sioux Falls, South Dakota, United States

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee, United States

Alina Clinical Trials, LLC.

Dallas, Texas, United States

North Texas Center for Clinical Research

Frisco, Texas, United States

DM Clinical Research - Cy Fair

Houston, Texas, United States

SCLA Management - Drop Box

Houston, Texas, United States

SCLA Management Office

Houston, Texas, United States

NeuroCare Plus

Houston, Texas, United States

Red Star Research, LLC

Lake Jackson, Texas, United States

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

McAllen, Texas, United States

DCT-Stone Oak, LLC dba Discovery Clinical Trials

San Antonio, Texas, United States

Texas Institute for Neurological Disorders

Sherman, Texas, United States

DM Clinical Research (Administrative Office Only)

Tomball, Texas, United States

Victoria Clinical Research Group

Victoria, Texas, United States

Meridian Clinical Research, LLC

Portsmouth, Virginia, United States

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

Vancouver, British Columbia, Canada

Centre Hospitalier Intercommunal de Créteil

Créteil, France

Centre Hospitalier Universitaire de Montpellier

Montpellier, France

Hopital des Enfants

Toulouse, France

UOSVD Centro Epilessia ed EEG dellEta Evolutiva

Bari, BARI / Puglia, Italy

Spedali Civili di Brescia

Brescia, Brescia/lombardy, Italy

Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic

Latina, Latina/lazio, Italy

IRCCS San Raffaele

Rome, Lazio, Italy

Istituto Neurologico "Carlo Besta" Fondazione IRCCS

Milan, Lombardy, Italy

Divisione di Neurologia, Ospedale Pediatrico Bambino Gesu

Rome, Rome/lazio, Italy

Jinnouchi Neurosurgical Clinic

Kasuga-shi, Fukuoka, Japan

Hikita Pediatric Clinic

Kiryu-shi, Gunma, Japan

Konan Medical Center

Higashinada-ku Kobe-shi, Hyōgo, Japan

Yamaguchi Clinic

Nishinomiya-shi, Hyōgo, Japan

Mito Kyodo General Hospital

Mito, Ibaraki, Japan

Tanaka Neurosurgery & Headache Clinic

Kagoshima, Kagoshima-ken, Japan

Atago Hospital

Kochi, Kochi, Japan

Sendai Headache and Neurology Clinic

Taihaku-ku Sendai-shi, Miyagi, Japan

Tennouji Dai Brain Clinic

Abeno-ku Osaka-shi, Osaka, Japan

Tominaga Clinic

Naniwa-ku, Osaka, Japan

Saitama Neuropsychiatric Institute

Chuo-ku Saitama-shi, Saitama, Japan

Tokyo Headache Clinic

Shibuya-ku, Tokyo, Japan

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo, Japan

LIAC Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital

Hiroshima, Japan

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

Poznan, Greater Poland Voivodeship, Poland

Wojewodzki Specjalistyczny Szpital Dzieciecy

Krakow, Lesser Poland Voivodeship, Poland

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, Lower Silesian Voivodeship, Poland

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

Lublin, Lublin Voivodeship, Poland

MTZ Clinical Research Powered by Pratia

Warsaw, Masovian Voivodeship, Poland

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

Katowice, Silesian Voivodeship, Poland

Neurologia Slaska Centrum Medyczne

Katowice, Silesian Voivodeship, Poland

Next Stage Sp. Z o.o.

Warsaw, WOJ. Mazowieckie, Poland

Hospital Universitari Parc Tauli

Sabadell, Barcelona, Spain

Hospital Clinico Universitario de Valladolid (HCUV)

Valladolid, Castille and León, Spain

Hospital Alvaro Cunqueiro

Vigo, Galicia, Spain

Instituto de Investigaciones del Sueno

Madrid, Spain

Virgen del Rocio Hospital

Seville, Spain

Hospital Universitario y Politecnico La Fe

Valencia, Spain