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NCT05156398PHASE3Recruiting

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

Pfizer

Start Date

2/28/2022

Completion Date

11/27/2032

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

Age Range: 6 years to 17 years

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.

Interventions

DRUG

Rimegepant

DRUG

Placebo

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Conditions

Migraine

Locations

The Belinga Clinic

Fort Smith, Arkansas 72901

United States

Advanced Investigative Medicine, Inc.

Hawthorne, California 90250

United States

Velocity Clinical Research San Diego

La Mesa, California 91942

United States

Colorado Springs Neurological Associates

Colorado Springs, Colorado 80907

United States

Advanced Neurosciences Research, LLC

Fort Collins, Colorado 80528

United States

Velocity Clinical Research, Washington DC

Washington D.C., District of Columbia 20016

United States

Accel Research Sites Network - Edgewater Clinical Research Unit

Edgewater, Florida 32132

United States

Direct Helpers Research Center

Hialeah, Florida 33012

United States

New Med Research, Inc

Hollywood, Florida 33020

United States

Complete Health Research

Ormond Beach, Florida 32174

United States

D&H Tamarac Research Center LLC

Tamarac, Florida 33321

United States

Santos Research Center, CORP

Tampa, Florida 33615

United States

Augusta University

Augusta, Georgia 30912

United States

WR-Mount Vernon Clinical Research, LLC

Sandy Springs, Georgia 30328

United States

Meridian Clinical Research, LLC

Savannah, Georgia 31406

United States

Extraordinary Family Healthcare

Snellville, Georgia 30078

United States

Renew Health Clinical Research LLC

Snellville, Georgia 30078

United States

Northwest Clinical Trials, Inc.

Boise, Idaho 83704

United States

Diamond Headache Clinic

Chicago, Illinois 60642

United States

Nola Research Works, LLC

New Orleans, Louisiana 70125

United States

Safe Haven Clinical Research

Clinton, Mississippi 39056

United States

Roy Blunt NextGen Precision Health Building

Columbia, Missouri 65211

United States

University of Missouri Health Care - Investigation Pharmacy

Columbia, Missouri 65212

United States

University of Missouri-Clinical and Translational Sciences Unit

Columbia, Missouri 65212

United States

University of Missouri

Columbia, Missouri 65212

United States

Velocity Clinical Research, Grand Island

Grand Island, Nebraska 68803

United States

Papillion Research Center/CCT Research

Papillion, Nebraska 68046

United States

Renown Regional Medical Center

Reno, Nevada 89502

United States

Dent Neurosciences Research Center, Inc.

Amherst, New York 14226

United States

Montefiore Medical Center

The Bronx, New York 10461

United States

Carolina Institute for Clinical Research, LLC

Fayetteville, North Carolina 28303

United States

Cincinnati Children's Hospital Medical Center

Cincinnati, Ohio 45229

United States

Velocity Clinical Research

Cincinnati, Ohio 45242

United States

Lynn Health Science Institute

Oklahoma City, Oklahoma 73112

United States

Coastal Pediatric Research

Charleston, South Carolina 29414

United States

Tribe Clinical Research LLC

Greenville, South Carolina 29607

United States

Avera McKennan Hospital & University Health Center

Sioux Falls, South Dakota 57105

United States

Avera Research Institute

Sioux Falls, South Dakota 57108

United States

Avera Medical Group Pediatrics - Dawley Farm

Sioux Falls, South Dakota 57110

United States

Monroe Carell Jr Children's Hospital at Vanderbilt

Nashville, Tennessee 37232

United States

Alina Clinical Trials, LLC.

Dallas, Texas 75209

United States

North Texas Center for Clinical Research

Frisco, Texas 75034

United States

DM Clinical Research - Cy Fair

Houston, Texas 77065

United States

SCLA Management - Drop Box

Houston, Texas 77077

United States

SCLA Management Office

Houston, Texas 77077

United States

NeuroCare Plus

Houston, Texas 77094

United States

Red Star Research, LLC

Lake Jackson, Texas 77566

United States

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

McAllen, Texas 78503

United States

DCT-Stone Oak, LLC dba Discovery Clinical Trials

San Antonio, Texas 78258

United States

Texas Institute for Neurological Disorders

Sherman, Texas 75092

United States

DM Clinical Research (Administrative Office Only)

Tomball, Texas 77375

United States

Victoria Clinical Research Group

Victoria, Texas 77901

United States

Meridian Clinical Research, LLC

Portsmouth, Virginia 23703

United States

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

Vancouver, British Columbia V6H 3V4

Canada

Centre Hospitalier Intercommunal de Creteil

Créteil, 94000

France

Centre Hospitalier Universitaire de Montpellier

Montpellier, 34295

France

Hopital des Enfants

Toulouse, 31059

France

UOSVD Centro Epilessia ed EEG dellEta Evolutiva

Bari, BARI / Puglia 70132

Italy

Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic

Latina, Latina/lazio 04100

Italy

IRCCS San Raffaele

Rome, Lazio 00166

Italy

Istituto Neurologico "Carlo Besta" Fondazione IRCCS

Milan, Lombardy 20133

Italy

Divisione di Neurologia, Ospedale Pediatrico Bambino Gesu

Rome, Rome/lazio 00165

Italy

ASST Spedali Civili di Brescia

Brescia, 25069

Italy

Jinnouchi Neurosurgical Clinic

Kasuga-shi, Fukuoka 816-0802

Japan

Hikita Pediatric Clinic

Kiryu-shi, Gunma 376-0035

Japan

Konan Medical Center

Higashinada-ku Kobe-shi, Hyōgo 658-0064

Japan

Yamaguchi Clinic

Nishinomiya-shi, Hyōgo 663-8204

Japan

Mito Kyodo General Hospital

Mito, Ibaraki 310-0015

Japan

Tanaka Neurosurgery & Headache Clinic

Kagoshima, Kagoshima-ken 890-0052

Japan

Atago Hospital

Kochi, Kochi 780-0051

Japan

Sendai Headache and Neurology Clinic

Taihaku-ku Sendai-shi, Miyagi 982-0014

Japan

Tennouji Dai Brain Clinic

Abeno-ku Osaka-shi, Osaka 545-0053

Japan

Tominaga Clinic

Naniwa-ku, Osaka 556-0015

Japan

Saitama Neuropsychiatric Institute

Chuo-ku Saitama-shi, Saitama 338-8577

Japan

Tokyo Headache Clinic

Shibuya-ku, Tokyo 151-0051

Japan

Tokyo Medical University Hospital

Shinjuku-ku, Tokyo 160-0023

Japan

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

Poznan, Greater Poland Voivodeship 61-731

Poland

Wojewodzki Specjalistyczny Szpital Dzieciecy

Krakow, Lesser Poland Voivodeship 31-503

Poland

MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak

Wroclaw, Lower Silesian Voivodeship 52-210

Poland

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

Lublin, Lublin Voivodeship 20-064

Poland

MTZ Clinical Research Powered by Pratia

Warsaw, Masovian Voivodeship 02-172

Poland

NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS

Katowice, Silesian Voivodeship 40-123

Poland

Neurologia Slaska Centrum Medyczne

Katowice, Silesian Voivodeship 40-689

Poland

Next Stage Sp. Z o.o.

Warsaw, WOJ. Mazowieckie 02-121

Poland

Hospital Universitari Parc Tauli

Sabadell, Barcelona 08208

Spain

Hospital Clinico Universitario de Valladolid (HCUV)

Valladolid, Castille and León 47003

Spain

Hospital Alvaro Cunqueiro

Vigo, Galicia 36312

Spain

Instituto de Investigaciones del Sueno

Madrid, 28036

Spain

Virgen del Rocio Hospital

Seville, 41013

Spain

Hospital Universitario y Politecnico La Fe

Valencia, 46026

Spain