Phase
Condition
Pain (Pediatric)
Oral Facial Pain
Headaches
Treatment
Placebo
Rimegepant
Clinical Study ID
Ages 6-17 All Genders
Study Summary
Eligibility Criteria
Inclusion
Inclusion Criteria:
Subject has at least a 6 month history of migraine (with or without aura) andincluding the following:
14 or less headache days per month during the 3 month period prior to theScreening Visit
6 or more migraine days during the Observation Period
14 or less headache days during the Observation Period
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
Ability to verbally distinguish migraine attacks from tension/cluster or othertypes of headaches
Migraine attacks, on average, lasting 4 - 72 hours if untreated
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:
Subjects with a history of basilar migraine, cluster headaches, or hemiplegicmigraine
The subject has a continuous migraine (defined as an unrelenting headache) within 1month prior to Screening Visit.
The subject has a history or diagnosis of complications of migraine
The subject has a confounding and clinically significant pain syndrome that mayinterfere with the subject's ability to participate in this study.
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.
History of suicidal behavior or the subject is at risk of self-harm or harm toothers.
History of major psychiatric disorder.
The subject has a current diagnosis or history of substance abuse
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
Connect with a study center
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia V6H 3V4
CanadaSite Not Available
The Kids Clinic
Ajax, Ontario L1Z 0M1
CanadaActive - Recruiting
The Kids Clinic Inc
Ajax, Ontario L1Z0M1
CanadaSite Not Available
Children's Hospital of Eastern Ontario
Ottawa, Ontario K1H 8L1
CanadaSite Not Available
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000
FranceSite Not Available
CHU Gui de Chauliac
Montpellier, 34090
FranceSite Not Available
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295
FranceActive - Recruiting
Hopital des Enfants
Toulouse, 31059
FranceActive - Recruiting
Unita di Neurologia, Azienda Ospedaliera San Giuseppe Moscati
Avellino, Avellino/campania 83100
ItalyActive - Recruiting
UOSVD Centro Epilessia ed EEG dellEta Evolutiva
Bari, BARI / Puglia 70132
ItalySite Not Available
Spedali Civili di Brescia
Brescia, Brescia/lombardy 25123
ItalyActive - Recruiting
Azienda Ospedaliero Universitaria Meyer
Firenze, Florence 50139
ItalySite Not Available
Azienda Ospedaliero Universitaria Meyer
Florence, Florence/tuscany 50139
ItalyActive - Recruiting
Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic
Latina, Latina/lazio 04100
ItalyActive - Recruiting
Spaienza Universita di Roma Polo Pontino - ICOT, Headache clinic
Latina, Latina/lazio 04100
ItalySite Not Available
IRCCS San Raffaele
Roma, Lazio 00166
ItalyActive - Recruiting
Ospedale Pediatrico Bambino Gesu
Roma, Lazio 00165
ItalyActive - Recruiting
Istituto Neurologico "Carlo Besta" Fondazione IRCCS
Milano, Lombardia 20133
ItalySite Not Available
U.O. Neuropsichiatria Infantile, IRCCS Fondazione Mondino
Pavia, Lombardia 27100
ItalySite Not Available
U.O. di Neurologia- ASST Spedali Civili di Brescia
Brescia, Lombardy 25069
ItalySite Not Available
SS Centro Cefalee - UOC di Neurologia 3
Milan, Milan/lombardy 20133
ItalySite Not Available
Fondazione Mondino - Istituto Neurologico Nazionale IRCCS
Pavia, Padua 27100
ItalySite Not Available
IRCCS San Raffaele
Rome, ROME / Latium 00163
ItalySite Not Available
Divisione di Neurologia, Ospedale Pediatrico Bambino Gesu
Rome, Rome/lazio 00165
ItalySite Not Available
Presidio Ospedaliero San Paolo
Bari, 70132
ItalySite Not Available
Istituto neurologico Carlo Besta
Milano, 20133
ItalySite Not Available
Dipartimento Materno Infantile e Scienze UroGinecologiche - UOC Pediatria
Roma, 00161
ItalyActive - Recruiting
IRCCS San Raffaele Roma
Rome, 00197
ItalySite Not Available
Medical Corporation Seikokai Takanoko Hospital
Matsuyama-shi, Ehime 790-0925
JapanSite Not Available
Jinnouchi Neurosurgical Clinic
Kasuga-shi, Fukuoka 816-0802
JapanActive - Recruiting
Hikita Pediatric Clinic
Kiryu-shi, Gunma 376-0035
JapanSite Not Available
Hiroshima City Hiroshima Citizens Hospital
Naka-ku Hiroshima-shi, Hiroshima 730-8518
JapanSite Not Available
Konan Medical Center
Higashinada-ku Kobe-shi, Hyōgo 658-0064
JapanSite Not Available
Yamaguchi Clinic
Nishinomiya-shi, Hyōgo 663-8204
JapanActive - Recruiting
Mito Kyodo General Hospital
Mito-shi, Ibaraki 310-0015
JapanSite Not Available
Tanaka Neurosurgery & Headache Clinic
Kagoshima-city, Kagoshima 890-0052
JapanActive - Recruiting
Tanaka Neurosurgical Clinic
Kagoshima-shi, Kagoshima 892-0844
JapanSite Not Available
Atago Hospital
Kochi-shi, Kōchi 780-0051
JapanActive - Recruiting
Sendai Headache and Neurology Clinic
Taihaku-ku Sendai-shi, Miyagi 982-0014
JapanActive - Recruiting
Tennouji Dai Brain Clinic
Abeno-ku Osaka-shi, Osaka 545-0053
JapanActive - Recruiting
Tominaga Clinic
Naniwa-ku, Osaka 556-0015
JapanActive - Recruiting
Tominaga Clinic
Naniwa-ku, Osaka-shi, Osaka 556-0015
JapanSite Not Available
Saitama Neuropsychiatric Institute
Chuo-ku Saitama-shi, Saitama 338-8577
JapanActive - Recruiting
Tokyo Headache Clinic
Shibuya-ku, Tokyo 151-0051
JapanActive - Recruiting
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo 160-0023
JapanSite Not Available
Tokyo Medical University Hospital
Shinjyuku-ku, Tokyo 160-0023
JapanSite Not Available
LIAC Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518
JapanSite Not Available
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, Dolnoslaskie 52-210
PolandActive - Recruiting
Indywidualna Praktyka Lekarska Dr Hab. Med. Anna Szczepanska-Szerej
Lublin, Lubelskie 20-582
PolandSite Not Available
NZOZ Neuromed M. i M. Nastaj Sp. P.
Lublin, Lubelskie 20-064
PolandActive - Recruiting
Wojewodzki Specjalistyczny Szpital Dzieciecy
Krakow, Malopolskie 31-503
PolandActive - Recruiting
MTZ Clinical Research Powered by Pratia
Warszawa, Mazowieckie 02-172
PolandActive - Recruiting
Next Stage Sp. Z o.o.
Warszawa, Mazowieckie 02-121
PolandActive - Recruiting
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
Katowice, Slaskie 40-123
PolandSite Not Available
Neurologia Slaska Centrum Medyczne
Katowice, Slaskie 40-689
PolandActive - Recruiting
Next Stage Sp. Z o.o.
Warsaw, WOJ. Mazowieckie 02-121
PolandActive - Recruiting
Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
Poznan, Wielkopolskie 61-731
PolandActive - Recruiting
Wojewodzki Specjalistyczny Szpital Dzieciecy im. sw. Ludwika w Krakowie
Krakow, 31-503
PolandSite Not Available
MTZ Clinical Research Sp. z o.o.
Warszawa, 02-106
PolandActive - Recruiting
Hospital Universitari Parc Tauli
Sabadell, Barcelona 08208
SpainActive - Recruiting
Hospital Clinico Universitario de Valladolid (HCUV)
Valladolid, Castilla Y LEON 47003
SpainActive - Recruiting
Hospital Alvaro Cunqueiro
Vigo, Galicia 36312
SpainActive - Recruiting
Hospital Clinico Universitario de Santiago de Compostela
Santiago de Compostela, LA Coruna 15706
SpainSite Not Available
Hospital Universitari Parc Taulí Institut d'Investigació i Innovació Parc Taulí
Barcelona, 08208
SpainSite Not Available
Instituto de Investigaciones del Sueno
Madrid, 28036
SpainSite Not Available
Virgen del Rocio Hospital
Sevilla, 41013
SpainActive - Recruiting
Hospital Universitario y Politecnico La Fe
Valencia, 46026
SpainActive - Recruiting
The Belinga Clinic
Fort Smith, Arkansas 72901
United StatesSite Not Available
Advanced Investigative Medicine, Inc.
Hawthorne, California 90250
United StatesActive - Recruiting
Velocity Clinical Research San Diego
La Mesa, California 91942
United StatesSite Not Available
Palo Alto Medical Foundation
Palo Alto, California 94301
United StatesSite Not Available
Care Access
Pasadena, California 91101
United StatesSite Not Available
Clinical Research of California
Walnut Creek, California 94598
United StatesSite Not Available
Colorado Springs Neurological Associates
Colorado Springs, Colorado 80907
United StatesActive - Recruiting
Advanced Neurosciences Research, LLC
Fort Collins, Colorado 80528
United StatesActive - Recruiting
Hasbani Neurology
New Haven, Connecticut 06511
United StatesSite Not Available
Meridian Clinical Research, LLC
Washington, District of Columbia 20016
United StatesActive - Recruiting
Synergy Healthcare
Bradenton, Florida 34209
United StatesActive - Recruiting
Vertex Research Group
Clermont, Florida 34711
United StatesSite Not Available
Accel Research Sites Network - Edgewater Clinical Research Unit
Edgewater, Florida 32132
United StatesSite Not Available
Complete Health Research
Edgewater, Florida 32132
United StatesActive - Recruiting
Direct Helpers Research Center
Hialeah, Florida 33012
United StatesActive - Recruiting
New Med Research, Inc
Hollywood, Florida 33020
United StatesTerminated
Axcess Medical Research
Loxahatchee Groves, Florida 33470
United StatesSite Not Available
Sanitas Research, LLC
Miami, Florida 33155
United StatesSite Not Available
APG Research, LLC
Orlando, Florida 32803
United StatesSite Not Available
Complete Health Research
Ormond Beach, Florida 32174
United StatesSite Not Available
D&H Tamarac Research Center LLC
Tamarac, Florida 33321
United StatesActive - Recruiting
Santos Research Center
Tampa, Florida 33615
United StatesSite Not Available
Santos Research Center, CORP
Tampa, Florida 33615
United StatesActive - Recruiting
Augusta University
Augusta, Georgia 30912
United StatesActive - Recruiting
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia 30328
United StatesSite Not Available
Meridian Clinical Research, LLC
Savannah, Georgia 31406
United StatesSite Not Available
Extraordinary Family Healthcare
Snellville, Georgia 30078
United StatesSite Not Available
Renew Health Clinical Research LLC
Snellville, Georgia 30078
United StatesSite Not Available
Northwest Clinical Trials, Inc.
Boise, Idaho 83704
United StatesActive - Recruiting
Diamond Headache Clinic
Chicago, Illinois 60642
United StatesTerminated
Research Works INC
New Orleans, Louisiana 70125
United StatesSite Not Available
Clinical Research Institute
Minneapolis, Minnesota 55402
United StatesSite Not Available
Safe Haven Clinical Research
Clinton, Mississippi 39056
United StatesActive - Recruiting
Safe Haven Clinical Research
Natchez, Mississippi 39120
United StatesSite Not Available
Safe Haven Clinical Research,Inc.
Clinton, Missouri 39056
United StatesSite Not Available
MU Child Health
Columbia, Missouri 65201
United StatesSite Not Available
University of Missouri
Columbia, Missouri 65212
United StatesActive - Recruiting
University of Missouri - Investigational Pharmacy
Columbia, Missouri 65212
United StatesActive - Recruiting
University of Missouri Health Care - Clinical Research Center
Columbia, Missouri 65212
United StatesActive - Recruiting
University of Missouri Health Care - Investigation Pharmacy (IP to be shipped here)
Columbia, Missouri 65212
United StatesActive - Recruiting
University of Missouri Health Care - Pathology Department
Columbia, Missouri 65212
United StatesActive - Recruiting
University of Missouri School of Medicine
Columbia, Missouri 65212
United StatesActive - Recruiting
AMR Kansas City
Kansas City, Missouri 64114
United StatesSite Not Available
Velocity Clinical Research, Inc.
Grand Island, Nebraska 68803
United StatesActive - Recruiting
Meridian Clinical Research, LLC
Hastings, Nebraska 68901
United StatesActive - Recruiting
Velocity Clinical Research, Inc.
Hastings, Nebraska 68901
United StatesSite Not Available
Midwest Children's Health Research Institute, LLC
Lincoln, Nebraska 68504
United StatesSite Not Available
CCT Research
Papillion, Nebraska 68046
United StatesSite Not Available
Papillion Research Center/CCT Research
Papillion, Nebraska 68046
United StatesActive - Recruiting
Renown Regional Medical Center
Reno, Nevada 89502
United StatesSite Not Available
Ocean Medical Research
Toms River, New Jersey 08755
United StatesSite Not Available
Albuquerque Neuroscience Inc.
Albuquerque, New Mexico 87109
United StatesSite Not Available
Dent Neurosciences Research Center, Inc.
Amherst, New York 14226
United StatesActive - Recruiting
Montefiore Medical Center
Bronx, New York 10461
United StatesActive - Recruiting
Rochester Clinical Research, Inc.
Rochester, New York 14609
United StatesSite Not Available
CICR
Fayetteville, North Carolina 28303
United StatesSite Not Available
Carolina Institute for Clinical Research, LLC
Fayetteville, North Carolina 28303
United StatesSite Not Available
Trinity Health
Minot, North Dakota 58701
United StatesSite Not Available
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio 45229
United StatesActive - Recruiting
Velocity Clinical Research
Cincinnati, Ohio 45242
United StatesSite Not Available
Optimed Research
Columbus, Ohio 43235
United StatesSite Not Available
Lynn Health Science Institute
Oklahoma City, Oklahoma 73112
United StatesSite Not Available
Coastal Pediatric Research
Charleston, South Carolina 29414
United StatesSite Not Available
Meridian Clinical Research, LLC
Charleston, South Carolina 29407
United StatesActive - Recruiting
Tribe Clinical Research LLC
Greenville, South Carolina 29607
United StatesSite Not Available
Tribe Clinical Research
Spartanburg, South Carolina 29301
United StatesSite Not Available
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota 57105
United StatesActive - Recruiting
Avera McKennan d/b/a Avera Research Institute
Sioux Falls, South Dakota 57108
United StatesSite Not Available
Avera Medical Group Pediatric Specialists
Sioux Falls, South Dakota 57105
United StatesActive - Recruiting
Avera Research Institute
Sioux Falls, South Dakota 57108
United StatesActive - Recruiting
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee 37232
United StatesActive - Recruiting
TIND
Arlington, Texas 76015
United StatesSite Not Available
Alina Clinical Trials, LLC Barbara Baxter, Sole MBR
Dallas, Texas 75225
United StatesSite Not Available
Alina Clinical Trials, LLC.
Dallas, Texas 75209
United StatesActive - Recruiting
DCT-Baxter Research, LLC dba Discovery Clinical Trials
Dallas, Texas 75225
United StatesActive - Recruiting
North Texas Center for Clinical Research
Frisco, Texas 75034
United StatesActive - Recruiting
DM Clinical Research - Cy Fair
Houston, Texas 77065
United StatesActive - Recruiting
NeuroCare Plus
Houston, Texas 77094
United StatesActive - Recruiting
SCLA Management
Houston, Texas 77079
United StatesActive - Recruiting
SCLA Management - Drop Box
Houston, Texas 77077
United StatesActive - Recruiting
SCLA Management Office
Houston, Texas 77077
United StatesActive - Recruiting
Red Star Research, LLC
Lake Jackson, Texas 77566
United StatesActive - Recruiting
FMC Science
Lampasas, Texas 76550
United StatesSite Not Available
DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas 78503
United StatesActive - Recruiting
DCT-Baxter Research, LLC dba Discovery Clinical Trials
San Antonio, Texas 78230
United StatesSite Not Available
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas 78258
United StatesActive - Recruiting
Texas Institute for Neurological Disorders
Sherman, Texas 75092
United StatesActive - Recruiting
DM Clinical Research (Administrative Office Only)
Tomball, Texas 77375
United StatesActive - Recruiting
Victoria Clinical Research Group
Victoria, Texas 77901
United StatesActive - Recruiting
South Ogden Family Medicine
South Ogden, Utah 84405
United StatesSite Not Available
South Ogden Family Medicine Ogden Clinic/CCT Research
South Ogden, Utah 84405
United StatesActive - Recruiting
Meridian Clinical Research, LLC
Portsmouth, Virginia 23703
United StatesSite Not Available
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