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Taking people in United StatesPhase 3

Long-term safety of rimegepant for migraine in children and teens

Tests long-term safety of rimegepant for acute migraine in children aged 6 to 17.

Key facts

Who runs it
Pfizer
Where
Amherst, Anaheim, Ann Arbor, Atlanta, Aurora, Austin, Bellaire, Bellevue, Brunswick, Charlotte, Charlottesville, Chicago, Cincinnati, Clarksville, Cleveland, Colorado Springs, Commack, Cromwell, Culver City, Dallas, Dayton, Decatur, East Greenwich, El Paso, Fresno, Frisco, Grand Junction, Grand Rapids, Grants Pass, Great Falls, Greensboro, Greenville, Greer, Houston, Kalamazoo, Kalispell, Kansas City, La Jolla, Lexington, Lincoln, Long Beach, Madison, Memphis, Miami, Missoula, Naperville, Nashville, Neptune City, New Orleans, New York, Norfolk, North Hollywood, Oklahoma City, Omaha, Orange Park, Orlando, Ozark, Philadelphia, Plano, Pomona, Port Jefferson Station, Portland, Richmond, Royal Oak, Sacramento, Salt Lake City, San Bernardino, Scottsdale, Seattle, Springfield, Stamford, Tampa, Tempe, Upland, Walnut Creek, Waltham, Washington D.C., West Des Moines, West Palm Beach, and Westfield, United StatesSee the 113 sitesAlso in 2 other countries, 8 sites
Registry title
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Status
Recruiting
Phase
Phase 3
People taking part
600 people, planned
Started
28 Apr 2021
Expected to end
31 Jul 2030
Type of study
Interventional
Treatments tested
  • Rimegepant (PF-07899801)
Record updated
27 October 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for children and teenagers aged 6 to under 18 who have migraine and need treatment for attacks. It tests the long-term safety of rimegepant.

Age
6 to under 18 years (must not turn 18 on or before the Baseline visit).
Sex
Boys and girls can both join.
Disease stage
Migraine, with or without aura, for at least 6 months. 1 to 8 moderate or severe attacks per month in the 2 months before screening.
Earlier treatment
Migraine prevention medicine is allowed if the dose has been stable for at least 12 weeks before the Screening Visit.

Main reasons for not taking part

  • History of cluster headache or hemiplegic migraine headache
  • Another clinically significant pain syndrome
  • Uncontrolled or untreated psychiatric condition, or history of psychosis or mania
  • History of suicidal behavior or risk of self-harm or harm to others
  • Current or past substance abuse, or positive test for drugs of abuse

The registry criteria, word for word

Show all 15 criteriaShow less

Who can take part

  • 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)

Who cannot take part

  • 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)
  • Reported current use of or tested positive at Screening for drugs of abuse
  • History of cluster headache or hemiplegic migraine headache
  • Confounding and clinically significant pain syndrome
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 6 and 17 years old?

Where in United States

Also in 2 other countries, 8 sites

  • Dent Neurosciences Research CenterAmherst, United StatesTaking people
  • Advanced Research Center, Inc.Anaheim, United StatesTaking people
  • Michigan Head Pain and Neurological InstituteAnn Arbor, United StatesTaking people
  • Rare Disease Research, LLCAtlanta, United StatesNo longer taking part
  • Children's Hospital ColoradoAurora, United StatesTaking people
  • Children's Hospital Colorado- Investigational Drug ServicesAurora, United StatesTaking people
  • Child Neurology Consultants of Austin - Central AustinAustin, United StatesTaking people
  • Dell Children's Medical CenterAustin, United StatesTaking people
  • Child Neurology Consultants of Austin - South AustinAustin, United StatesNo longer taking part
  • Houston Clinical Trials, LLCBellaire, United StatesTaking people
  • Northwest Clinical Research CenterBellevue, United StatesTaking people
  • Pivotal Clinical Research & Associates, LLCBrunswick, United StatesNo longer taking part
  • Onsite Clinical Solutions, LLCCharlotte, United StatesTaking people
  • Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)Charlottesville, United StatesTaking people
  • Pediatric Research of Charlottesville, LLCCharlottesville, United StatesTaking people
  • Pediatric Research of Charlottesville, LLC (Regulatory Only)Charlottesville, United StatesTaking people
  • Chicago Headache Center & Research InstituteChicago, United StatesTaking people
  • Cincinnati Children's HospitalCincinnati, United StatesTaking people
  • Velocity Clinical Research - CincinnatiCincinnati, United StatesNo longer taking part
  • WellNow Urgent Care and ResearchCincinnati, United StatesNo longer taking part
  • Novaceut Clinical ResearchClarksville, United StatesNo longer taking part
  • University Hospitals Cleveland Medical Center*Cleveland, United StatesTaking people
  • Colorado Springs Neurological Associates, PCColorado Springs, United StatesNo longer taking part
  • True North NeurologyCommack, United StatesTaking people
  • CT Clinical ResearchCromwell, United StatesTaking people
  • ProScience Research GroupCulver City, United StatesNo longer taking part
  • Cedar Health ResearchDallas, United StatesNo longer taking part
  • Infinite Research Group, LLCDallas, United StatesNo longer taking part
  • Wellnow Urgent Care and ResearchDayton, United StatesNo longer taking part
  • CenExel iResearch, LLCDecatur, United StatesTaking people
  • Velocity Clinical Research, ProvidenceEast Greenwich, United StatesTaking people
  • ANESC ResearchEl Paso, United StatesTaking people
  • Neuro Pain Research CenterFresno, United StatesTaking people
  • North Texas Institute of Neurology and HeadacheFrisco, United StatesNo longer taking part
  • Boeson Research GJTGrand Junction, United StatesNo longer taking part
  • Dinosaur PediatricsGrand Junction, United StatesNo longer taking part
  • Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical GroupGrand Rapids, United StatesTaking people
  • Corewell Health, Helen DeVos Children's HospitalGrand Rapids, United StatesTaking people
  • Velocity Clinical Research, Grants PassGrants Pass, United StatesNo longer taking part
  • Boeson ResearchGreat Falls, United StatesNo longer taking part
  • Headache Wellness Center, PCGreensboro, United StatesNo longer taking part
  • Velocity Clinical Research - GreenvilleGreenville, United StatesNo longer taking part
  • Premier NeurologyGreer, United StatesNo longer taking part
  • NeuroCare PlusHouston, United StatesTaking people
  • Pain and Headache Centers of TexasHouston, United StatesTaking people
  • SCLA ManagementHouston, United StatesTaking people
  • Houston Clinical Research,LLC.Houston, United StatesNo longer taking part
  • Trio Clinical Trials, LLC.Houston, United StatesNo longer taking part
  • Wellnow Urgent Care and ResearchKalamazoo, United StatesNo longer taking part
  • Heart & Hands MidwiferyKalispell, United StatesNo longer taking part
  • Clinical Associates Midwest, LLCKansas City, United StatesTaking people
  • Altman Clinical and Translational Research Institute, University of California San DiegoLa Jolla, United StatesTaking people
  • University of Kentucky HospitalLexington, United StatesNo longer taking part
  • Alivation Research, LLCLincoln, United StatesNo longer taking part
  • Adult & Child Neurology Medical AssociatesLong Beach, United StatesTaking people
  • MemorialCare Miller Children's & Women's Hospital Long BeachLong Beach, United StatesTaking people
  • University HospitalMadison, United StatesTaking people
  • Le Bonheur Children's HospitalMemphis, United StatesNo longer taking part
  • Le Bonheur Childrens Hospital - Childrens Foundation Research InstituteMemphis, United StatesNo longer taking part
  • Le Bonheur Childrens Hospital - Outpatient BuildingMemphis, United StatesNo longer taking part
  • South Florida Research Phase I-IV, IncMiami, United StatesTaking people
  • AppleMed Research Group, LLCMiami, United StatesNo longer taking part
  • Medical Research Center of Miami II, IncMiami, United StatesNo longer taking part
  • Blue Moose PediatricsMissoula, United StatesNo longer taking part
  • Boeson ResearchMissoula, United StatesNo longer taking part
  • Boeson Research LaboratoryMissoula, United StatesNo longer taking part
  • AMR-Baber Research IncNaperville, United StatesTaking people
  • Access Clinical Trials, IncNashville, United StatesNo longer taking part
  • HMH Jersey Shore University Medical CenterNeptune City, United StatesTaking people
  • Hope TowerNeptune City, United StatesTaking people
  • Ochsner Clinic FoundationNew Orleans, United StatesNo longer taking part
  • New York Neurology AssociatesNew York, United StatesTaking people
  • Columbia University Irving Medical CenterNew York, United StatesNo longer taking part
  • Irving Center for Clinical and Translational Research, Outpatient Clinical Research UnitNew York, United StatesNo longer taking part
  • Mount Sinai Hospital - Pharmacy DepartmentNew York, United StatesNo longer taking part
  • The Neurological Institute of New YorkNew York, United StatesNo longer taking part
  • Children's Hospital of The King's DaughtersNorfolk, United StatesTaking people
  • CHKD Health CenterNorfolk, United StatesTaking people
  • Velocity Clinical Research - North HollywoodNorth Hollywood, United StatesNo longer taking part
  • IPS Research CompanyOklahoma City, United StatesNo longer taking part
  • Children'S Hospital & Medical CenterOmaha, United StatesTaking people
  • Physicians Group Services, PA d/b/a Coastal Health ResearchOrange Park, United StatesNo longer taking part
  • Clinical Associates of Orlando, LLCOrlando, United StatesTaking people
  • Sharlin Health Neuroscience Research CenterOzark, United StatesNo longer taking part
  • Children's Hospital of PhiladelphiaPhiladelphia, United StatesNo longer taking part
  • ClarioPhiladelphia, United StatesNo longer taking part
  • Aim Trials, LLCPlano, United StatesNo longer taking part
  • The Neurology GroupPomona, United StatesTaking people
  • North Suffolk NeurologyPort Jefferson Station, United StatesNo longer taking part
  • Providence Neuroscience Institute: Research Coordinators' OfficePortland, United StatesTaking people
  • Providence Pediatric Specialty ClinicPortland, United StatesTaking people
  • National Clinical Research, IncRichmond, United StatesNo longer taking part
  • Beaumont Hospital Royal Oak CampusRoyal Oak, United StatesTaking people
  • UC Davis Medical Center, Investigational Drug Service (IDS) PharmacySacramento, United StatesNo longer taking part
  • University of California, Davis Clinical and Translational Science Center Clinical Research CenterSacramento, United StatesNo longer taking part
  • University of California, Davis Midtown ClinicSacramento, United StatesNo longer taking part
  • JBR Clinical ResearchSalt Lake City, United StatesTaking people
  • Wasatch Clinical Research , LLC(Administrative Location)Salt Lake City, United StatesTaking people
  • Velocity Clinical Research- BanningSan Bernardino, United StatesNo longer taking part
  • Perseverance Research Center, LLCScottsdale, United StatesTaking people
  • Seattle Children's HospitalSeattle, United StatesTaking people
  • Seattle Children's Hospital Investigational Drug ServicesSeattle, United StatesTaking people
  • Clinvest Research, LLCSpringfield, United StatesNo longer taking part
  • Ki Health Partners, LLc, dba New England Institute for Clinical ResearchStamford, United StatesTaking people
  • ForCare Clinical ResearchTampa, United StatesNo longer taking part
  • Physicians Research GroupTempe, United StatesNo longer taking part
  • Pacific Clinical Research Management Group LLCUpland, United StatesNo longer taking part
  • Sunwise Clinical ResearchWalnut Creek, United StatesTaking people
  • MedVadis Research CorporationWaltham, United StatesNo longer taking part
  • Children's National Medical CenterWashington D.C., United StatesTaking people
  • Integrated Clinical Trial Services, Inc.West Des Moines, United StatesTaking people
  • Premiere Research Institute at Palm Beach NeurologyWest Palm Beach, United StatesNo longer taking part
  • Options Research Group, LLCWestfield, United StatesTaking people

About the trial

What the trial wants to find out

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).

The group in the trial

  • ActiveTreatment being tested

    rimegepant 75 mg, 50 mg or 35 mg ODT

    Treatment: Rimegepant (PF-07899801)

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
Phase 3, Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of Rimegepant for the Acute Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age
Plain-language title
Long-term safety of rimegepant for migraine in children and teensGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT04743141, who can take part
Record updated
27 October 2026