Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
- Registration Number
- NCT04743141
- Lead Sponsor
- Pfizer
- Brief Summary
The purpose of this study is to test the long-term safety of rimegepant in the acute treatment of migraine in children and adolescents (≥ 6 to \< 18 years of age).
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 200
- History of migraine (with or without aura) for ≥ 6 months before Screening.
- History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.
- 1 or more migraine days requiring treatment during the Observation Phase.
- Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.
- Ability to distinguish between migraine and other types of headaches.
- Weight > 15 kg.
- Adequate venous access for blood sampling.
- Male and female participants 6 to < 18 years of age (participants must not reach their 18th birthday before enrollment into the study)
- History of cluster headache or hemiplegic migraine headache.
- Confounding and clinically significant pain syndrome.
- Current uncontrolled and/or untreated psychiatric condition for a minimum of 6 months prior to the Screening Visit (lifetime history of psychosis and/or mania are excluded).
- History of suicidal behavior or at risk of self-harm/harm to others.
- History of major psychiatric disorder.
- Current diagnosis or history of substance abuse
- Reported current use of or tested positive at Screening for drugs of abuse.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Active Rimegepant (PF-07899801) rimegepant 75 mg, 50 mg or 35 mg ODT
- Primary Outcome Measures
Name Time Method The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities 58 weeks To evaluate the safety and tolerability of rimegepant in children and adolescents (≥ 6 to \< 18 years of age).
- Secondary Outcome Measures
Name Time Method The frequency and severity of hepatic-related adverse events and frequency of hepatic-related adverse events leading to treatment discontinuation 58 weeks To evaluate the frequency and severity of hepatic-related adverse events and the frequency of hepatic-related treatment discontinuations in children and adolescents (6 to less than 18 years of age) treated with rimegepant.
Trial Locations
- Locations (146)
Memorialcare Miller Children's & Women's Hospital Long Beach
🇺🇸Long Beach, California, United States
Integrated Clinical Trial Services
🇺🇸West Des Moines, Iowa, United States
NeuroCare Plus
🇺🇸Houston, Texas, United States
Physicians Research Group
🇺🇸Tempe, Arizona, United States
Perseverance Research Center, LLC
🇺🇸Scottsdale, Arizona, United States
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
Velocity Clinical Research- Banning
🇺🇸San Bernardino, California, United States
The Neuron Clinic
🇺🇸Chula Vista, California, United States
ProScience Research Group
🇺🇸Culver City, California, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
Sunwise Clinical Research
🇺🇸Lafayette, California, United States
Miller Children's & Women's Hospital Long Beach
🇺🇸Long Beach, California, United States
Children's Hospital Los Angeles - Children's Hospital Los Angeles Dept of Pharmacy
🇺🇸Los Angeles, California, United States
Children's Hospital Los Angeles, Division of Neurology
🇺🇸Los Angeles, California, United States
National Research Institute
🇺🇸Los Angeles, California, United States
Velocity Clinical Research - North Hollywood
🇺🇸North Hollywood, California, United States
The Neurology Group
🇺🇸Pomona, California, United States
UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
🇺🇸Sacramento, California, United States
UC Davis
🇺🇸Sacramento, California, United States
University of California, Davis Clinical and Translational Science Center Clinical Research Center
🇺🇸Sacramento, California, United States
University of California, Davis Midtown Clinic
🇺🇸Sacramento, California, United States
Rady Children's Hospital
🇺🇸San Diego, California, United States
Pacific Clinical Research Management Group LLC
🇺🇸Upland, California, United States
Children's Hospital Colorado Investigational Drug Services
🇺🇸Aurora, Colorado, United States
Children's Hospital Colorado- Investigational Drug Services
🇺🇸Aurora, Colorado, United States
Children's Hospital Colorado
🇺🇸Aurora, Colorado, United States
Colorado Springs Neurological Associates
🇺🇸Colorado Springs, Colorado, United States
Boeson Research GJT
🇺🇸Grand Junction, Colorado, United States
Dinosaur Pediatrics
🇺🇸Grand Junction, Colorado, United States
Boeson Research - Grand Junction, CO
🇺🇸Grand Junction, Colorado, United States
CT Clinical Research
🇺🇸Cromwell, Connecticut, United States
Connecticut Children's Medical Center
🇺🇸Hartford, Connecticut, United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, United States
Sarkis Clinical Trials
🇺🇸Gainesville, Florida, United States
Multi-Specialty Research Associates, Inc.
🇺🇸Lake City, Florida, United States
South Florida Research Phase I-IV, Inc
🇺🇸Miami Springs, Florida, United States
AppleMed Research Group, LLC
🇺🇸Miami, Florida, United States
Medical Research Center of Miami II, Inc
🇺🇸Miami, Florida, United States
Brainstorm Research
🇺🇸Miami, Florida, United States
Coastal Clinical Research Specialists
🇺🇸Orange Park, Florida, United States
Orlando Health Arnold Palmer Hospital for Children-Pediatric Specialty Practice
🇺🇸Orlando, Florida, United States
Orlando Health Arnold Palmer Hospital for Children
🇺🇸Orlando, Florida, United States
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Premiere Research Institute at Palm Beach Neurology
🇺🇸West Palm Beach, Florida, United States
Children's Healthcare of Atlanta - Center for Advanced Pediatrics
🇺🇸Atlanta, Georgia, United States
Rare Disease Research LLC
🇺🇸Atlanta, Georgia, United States
Pivotal Clinical Research & Associates, LLC
🇺🇸Brunswick, Georgia, United States
CenExel iResearch, LLC
🇺🇸Decatur, Georgia, United States
Chicago Headache Center & Research Institute
🇺🇸Chicago, Illinois, United States
Children's Clinical Research Center at Riley Hospital for Children at IU Health
🇺🇸Indianapolis, Indiana, United States
Riley Hospital for Children at IU Health
🇺🇸Indianapolis, Indiana, United States
Physicians Research Group (Administrative Office Location)
🇺🇸Noblesville, Indiana, United States
College Park Family Care Center Physician Service Group - Neruology Research Department
🇺🇸Overland Park, Kansas, United States
University of Kentucky Hospital
🇺🇸Lexington, Kentucky, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
Boston Clinical Trials
🇺🇸Boston, Massachusetts, United States
MedVadis Research Corporation
🇺🇸Waltham, Massachusetts, United States
MedVadis Research
🇺🇸Waltham, Massachusetts, United States
Michigan Head Pain and Neurological Institute
🇺🇸Ann Arbor, Michigan, United States
Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group
🇺🇸Grand Rapids, Michigan, United States
Corewell Health, Helen DeVos Children's Hospital
🇺🇸Grand Rapids, Michigan, United States
Outpatient Pediatric Neurology Clinic
🇺🇸Grand Rapids, Michigan, United States
Wellnow Urgent Care and Research
🇺🇸Dayton, Ohio, United States
Beaumont Hospital, Royal Oak Campus
🇺🇸Royal Oak, Michigan, United States
Sharlin Health Neuroscience Research Center
🇺🇸Ozark, Missouri, United States
Clinvest Research, LLC
🇺🇸Springfield, Missouri, United States
Boeson Research
🇺🇸Missoula, Montana, United States
Northwest Physicians
🇺🇸Great Falls, Montana, United States
Boeson Research (HLN)
🇺🇸Helena, Montana, United States
Boeson Research,LLC
🇺🇸Kalispell, Montana, United States
Alivation Research, LLC
🇺🇸Lincoln, Nebraska, United States
HMH Jersey Shore University Medical Center
🇺🇸Neptune, New Jersey, United States
Dent Neurosciences Research Center
🇺🇸Amherst, New York, United States
New York Neurology Associates
🇺🇸New York, New York, United States
Mount Sinai Hospital - Pharmacy Department
🇺🇸New York, New York, United States
Columbia University Medical Center Research Pharmacy
🇺🇸New York, New York, United States
Columbia University Pediatric Neuromuscular Center
🇺🇸New York, New York, United States
Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
🇺🇸New York, New York, United States
The Neurological Institute of New York
🇺🇸New York, New York, United States
North Suffolk Neurology
🇺🇸Port Jefferson Station, New York, United States
Headache Wellness Center, PC
🇺🇸Greensboro, North Carolina, United States
Headache Wellness Center
🇺🇸Greensboro, North Carolina, United States
Atrium Health Wake Forest Baptist
🇺🇸Winston-Salem, North Carolina, United States
WellNow Urgent Care and Research
🇺🇸Cincinnati, Ohio, United States
Cincinnati Children's Hospital
🇺🇸Cincinnati, Ohio, United States
Drug Delivery-Cincinnati Children's IDS Denise Lagory
🇺🇸Cincinnati, Ohio, United States
Velocity Clinical Research - Cincinnati
🇺🇸Cincinnati, Ohio, United States
University Hospitals Cleveland Medical Center
🇺🇸Cleveland, Ohio, United States
IPS Research Company
🇺🇸Oklahoma City, Oklahoma, United States
Velocity Clinical Research, Grants Pass
🇺🇸Grants Pass, Oregon, United States
Providence Portland Medical Center
🇺🇸Portland, Oregon, United States
Providence Brain & Spine Institute-research coordinator's office
🇺🇸Portland, Oregon, United States
Providence Health & Services Investigational Drug Services Westside
🇺🇸Portland, Oregon, United States
Providence St. Vincent Medical Center
🇺🇸Portland, Oregon, United States
Children's Hospital of Philadelphia
🇺🇸Philadelphia, Pennsylvania, United States
Velocity Clinical Research-Providence
🇺🇸East Greenwich, Rhode Island, United States
Tribe Clinical Research LLC
🇺🇸Greenville, South Carolina, United States
Velocity Clinical Research- Greenville
🇺🇸Greenville, South Carolina, United States
Premier Neurology
🇺🇸Greer, South Carolina, United States
Coastal Carolina Research Center
🇺🇸North Charleston, South Carolina, United States
Novaceut Clinical Research
🇺🇸Clarksville, Tennessee, United States
Le Bonheur Children's Hospital
🇺🇸Memphis, Tennessee, United States
Le Bonheur Childrens Hospital - Childrens Foundation Research Institute
🇺🇸Memphis, Tennessee, United States
Le Bonheur Childrens Hospital - Outpatient Building
🇺🇸Memphis, Tennessee, United States
Access Clinical Trials, Inc.
🇺🇸Nashville, Tennessee, United States
Dell Children's Medical Center
🇺🇸Austin, Texas, United States
Child Neurology Consultants of Austin - South Austin
🇺🇸Austin, Texas, United States
Child Neurology Consultants of Austin - Central Austin
🇺🇸Austin, Texas, United States
Houston Clinical Trials, LLC
🇺🇸Bellaire, Texas, United States
Cedar Health Research
🇺🇸Dallas, Texas, United States
ANRC Research
🇺🇸El Paso, Texas, United States
North Texas Institute of Neurology and Headache
🇺🇸Frisco, Texas, United States
Trio Clinical Trials, LLC.
🇺🇸Houston, Texas, United States
Pain and Headache Centers of Texas
🇺🇸Houston, Texas, United States
SCLA Management
🇺🇸Houston, Texas, United States
Houston Clinical Research,LLC.
🇺🇸Houston, Texas, United States
AIM Trials, LLC
🇺🇸Plano, Texas, United States
JBR Clinical Research
🇺🇸Salt Lake City, Utah, United States
Wasatch Clinical Research , LLC(Administrative Location)
🇺🇸Salt Lake City, Utah, United States
Children's Hospital of The King's Daughters
🇺🇸Norfolk, Virginia, United States
Children's Specialty Group, PLLC , Division of Childhood & Adolescent Neurology
🇺🇸Norfolk, Virginia, United States
National Clinical Research, Inc.
🇺🇸Richmond, Virginia, United States
Northwest Clinical Research Center
🇺🇸Bellevue, Washington, United States
Eastside Therapeutic Resource, Inc. dba Core Clinical Research
🇺🇸Everett, Washington, United States
Seattle Children's Hospital Investigational Drug Services
🇺🇸Seattle, Washington, United States
Seattle Children's Hospital
🇺🇸Seattle, Washington, United States
University Hospital
🇺🇸Madison, Wisconsin, United States
University of Wisconsin-Madison
🇺🇸Madison, Wisconsin, United States
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
🇵🇱Katowice, Poland
Centrum Medyczne Plejady
🇵🇱Kraków, Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci
🇵🇱Krakow, Poland
Clinical Research Center Sp. z o.o.
🇵🇱Poznań, Poland
Clinical Research Center Spółka z ograniczoną odpowiedzialnością MEDIC-R Sp.k
🇵🇱Poznań, Poland
Euromedis Sp. z o.o. Osrodek B
🇵🇱Szczecin,, Poland
Pracownia Badan Klinicznych SALUS
🇵🇱Wroclaw, Poland
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
Centre Atencio Primaria (CAP) Balenya
🇪🇸Balenya, Barcelona, Spain
Hospital Universitario Marques de Valdecilla
🇪🇸Santander, Spain
Hospital Universitari Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitari Vall dHebron
🇪🇸Barcelona, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
CAP Balenyà
🇪🇸Barcelona, Spain
Instituto de Investigaciones del Sueno
🇪🇸Madrid, Spain
Hospital Universitario Virgen del Rocio (HUVR)
🇪🇸Sevilla, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain