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
- 600
- 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. For EU countries only: Participants 12 to < 18 years of age must have a body weight of >25kg.
- Adequate venous access for blood sampling.
- Male and female participants 6 to < 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).
- 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 (112)
Advanced Research Center, Inc.
🇺🇸Anaheim, California, United States
Perseverance Research Center, LLC
🇺🇸Scottsdale, Arizona, United States
Physicians Research Group
🇺🇸Tempe, Arizona, United States
ProScience Research Group
🇺🇸Culver City, California, United States
Neuro-Pain Medical Center
🇺🇸Fresno, California, United States
University of California San Diego, Altman Clinical and Translational Research Institute Clinic
🇺🇸La Jolla, California, United States
Sunwise Clinical Research
🇺🇸Lafayette, California, United States
Memorialcare Miller Children's & Women's Hospital Long Beach
🇺🇸Long Beach, 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
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
Velocity Clinical Research- Banning
🇺🇸San Bernardino, 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
🇺🇸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
CT Clinical Research
🇺🇸Cromwell, Connecticut, United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
🇺🇸Stamford, Connecticut, 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
ForCare Clinical Research
🇺🇸Tampa, Florida, United States
Premiere Research Institute at Palm Beach Neurology
🇺🇸West Palm Beach, Florida, United States
Childrens Healthcare of Atlanta
🇺🇸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
Physicians Research Group (Administrative Office Location)
🇺🇸Noblesville, Indiana, United States
Options Research Group, LLC
🇺🇸Westfield, Indiana, United States
Integrated Clinical Trial Services
🇺🇸West Des Moines, Iowa, United States
University of Kentucky Hospital
🇺🇸Lexington, Kentucky, United States
Ochsner Clinic Foundation
🇺🇸New Orleans, Louisiana, United States
MedVadis Research Corporation
🇺🇸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
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
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
True North Neurology
🇺🇸Commack, 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
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 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
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
Houston Clinical Research,LLC.
🇺🇸Houston, Texas, United States
NeuroCare Plus
🇺🇸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
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
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
🇵🇱Katowice, Poland
Centrum Medyczne Plejady
🇵🇱Krakow, Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci
🇵🇱Krakow, Poland
Clinical Research Center Sp. z o.o.
🇵🇱Poznań, Poland
Pracownia Badan Klinicznych SALUS
🇵🇱Wroclaw, Poland
Centrum Medyczne Oporow
🇵🇱Wroclaw, Poland
Centre Atencio Primaria (CAP) Balenya
🇪🇸Balenya, Barcelona, Spain
Hospital Universitario Vall d'Hebron
🇪🇸Barcelona, Spain
Hospital Universitario Virgen del Rocio
🇪🇸Sevilla, Spain
Hospital Clinico Universitario de Valladolid
🇪🇸Valladolid, Spain