Taking people in United StatesPhase 3
Tests rimegepant against placebo for migraine attacks in children
Tests rimegepant against placebo for moderate or severe migraine in children and teens.
Plain-language title generated from the registry record
Registry title: Randomized Study in Children and Adolescents With Migraine: Acute Treatment
Key facts
- Where
- Akron, Amherst, Anaheim, Ann Arbor, Apopka, Atlanta, Aurora, Austin, Bellaire, Bellevue, Birmingham, Boston, Brunswick, Burlington, Charlotte, Charlottesville, Chicago, Cincinnati, Cleveland, Colorado Springs, Columbus, Commack, Costa Mesa, Cromwell, Culver City, Cutler Bay, Dallas, Decatur, DeLand, East Greenwich, El Paso, Everett, Flowood, Fountain Valley, Fresno, Frisco, Gainesville, Grand Rapids, Grants Pass, Great Falls, Great Neck, Greensboro, Greenville, Hartford, Houston, Kalamazoo, Kalispell, Kansas City, Kenosha, Kingsport, La Jolla, Lake City, Lake Success, Lakeland, Lexington, Lincoln, Long Beach, Los Angeles, Madison, Memphis, Miami, Mineola, Missoula, Naperville, Naples, Nashville, Neptune City, New Orleans, New York, Norfolk, North Canton, North Hollywood, Oklahoma City, Omaha, Orange, Orange Park, Orlando, Overland Park, Ozark, Pembroke Pines, Philadelphia, Plano, Pomona, Port Jefferson Station, Portland, Richmond, Rochester, Royal Oak, Sacramento, Salt Lake City, San Bernardino, Scottsdale, Seattle, Shreveport, Sioux City, Springfield, Stamford, Tampa, Tempe, The Bronx, Tulsa, Upland, Walnut Creek, Waltham, Washington D.C., West Des Moines, West Palm Beach, Westfield, and Wilmington, United StatesSee the 167 sites
- Phase
- Phase 3
Could this be for you?
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?
Source: NCT04649242, who can take part
Where in United States
- Akron Children's HospitalAkron, United StatesNo longer taking part
- Dent Neurosciences Research CenterAmherst, United StatesTaking people
- Advanced Research Center, Inc.Anaheim, United StatesTaking people
- Michigan Head Pain & Neurological InstituteAnn Arbor, United StatesTaking people
- Topaz Clinical Research, Inc.Apopka, United StatesNo longer taking part
- Children's Healthcare of Atlanta, Inc.Atlanta, United StatesNo longer taking part
- Childrens Healthcare of AtlantaAtlanta, United StatesNo longer taking part
- Rare Disease Research, LLCAtlanta, United StatesNo longer taking part
- Children's Hospital ColoradoAurora, United StatesTaking people
- Children's Hospital Colorado- lnvestigational Drug ServicesAurora, United StatesTaking people
- Dell Children's Medical CenterAustin, United StatesTaking people
- BioBehavioral Research of AustinAustin, United StatesNo longer taking part
- Child Neurology Consultants of Austin - Central AustinAustin, United StatesNo longer taking part
- 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
- Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of AlabamaBirmingham, United StatesNo longer taking part
- Boston Clinical TrialsBoston, United StatesNo longer taking part
- Pivotal Clinical Research & Associates, LLCBrunswick, United StatesNo longer taking part
- The University of Vermont Medical CenterBurlington, United StatesNo longer taking part
- Onsite Clinical Solutions, LLCCharlotte, United StatesTaking people
- New Hope Clinical ResearchCharlotte, United StatesNo longer taking part
- 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 Hospital Medical CenterCincinnati, United StatesTaking people
- Velocity Clinical ResearchCincinnati, 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
- Nationwide Children's HospitalColumbus, United StatesNo longer taking part
- Wellnow Urgent Care and ResearchColumbus, United StatesNo longer taking part
- True North NeurologyCommack, United StatesTaking people
- Adult & Child Neurology Medical AssociatesCosta Mesa, United StatesTaking people
- CT Clinical ResearchCromwell, United StatesTaking people
- ProScience Research GroupCulver City, United StatesNo longer taking part
- Beautiful Minds Clinical Research CenterCutler Bay, United StatesNo longer taking part
- FutureSearch Trials of Dallas, LLCDallas, United StatesTaking people
- Cedar Health ResearchDallas, United StatesNo longer taking part
- Children's Medical Center DallasDallas, United StatesNo longer taking part
- Children's Medical Center, Pediatric Anesthesiology Research (Study supplies only)Dallas, United StatesNo longer taking part
- Infinite Research Group, LLCDallas, United StatesNo longer taking part
- The University of Texas Southwestern Medical CenterDallas, United StatesNo longer taking part
- CenExel iResearch, LLCDecatur, United StatesTaking people
- DeLand Clinical Research UnitDeLand, United StatesNo longer taking part
- Velocity Clinical Research, ProvidenceEast Greenwich, United StatesTaking people
- ANESC ResearchEl Paso, United StatesTaking people
- Eastside Therapeutic Resource, Inc. dba Core Clinical ResearchEverett, United StatesNo longer taking part
- Precise Research CentersFlowood, United StatesTaking people
- Memorial Health ServicesFountain Valley, United StatesTaking people
- Neuro Pain Research CenterFresno, United StatesTaking people
- North Texas Institute of Neurology and HeadacheFrisco, United StatesNo longer taking part
- Sarkis Clinical TrialsGainesville, 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
- Northwell Health IRBGreat Neck, United StatesTaking people
- Headache Wellness Center, PCGreensboro, United StatesNo longer taking part
- Premier Neurology, PCGreenville, United StatesNo longer taking part
- Tribe Clinical Research LLCGreenville, United StatesNo longer taking part
- Velocity Clinical Research - GreenvilleGreenville, United StatesNo longer taking part
- Connecticut Children's Medical CenterHartford, United StatesNo longer taking part
- NeuroCare PlusHouston, United StatesTaking people
- Pain and Headache Centers of TexasHouston, United StatesTaking people
- SCLA ManagementHouston, United StatesTaking people
- UTHealth HoustonHouston, United StatesTaking people
- Houston Clinical Research,LLC.Houston, United StatesNo longer taking part
- Wellnow Urgent Care and ResearchKalamazoo, United StatesNo longer taking part
- Boeson ResearchKalispell, United StatesNo longer taking part
- Heart & Hands MidwiferyKalispell, United StatesNo longer taking part
- Clinical Associates Midwest, LLCKansas City, United StatesTaking people
- Clinical Investigation Specialists, Inc.Kenosha, United StatesTaking people
- Holston Medical Group.Kingsport, United StatesNo longer taking part
- Altman Clinical and Translational Research Institute, University of California San DiegoLa Jolla, United StatesTaking people
- Multi-Specialty Research Associates, Inc.Lake City, United StatesNo longer taking part
- Northwell Health - Division of Pediatric NeurologyLake Success, United StatesTaking people
- Northwell Health Division of Pediatric Neurology Outpatient EEG LabLake Success, United StatesTaking people
- Watson Clinic Center for Research, Inc.Lakeland, United StatesNo longer taking part
- Watson Clinic LLPLakeland, United StatesNo longer taking part
- Kentucky Neuroscience Institute Child Neurology-- "Patients Seen"Lexington, United StatesNo longer taking part
- UK Center for Clinical and Translational Science (CCTS) -- "Patients Seen"Lexington, United StatesNo longer taking part
- 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
- Miller Children's & Women's Hospital Long BeachLong Beach, United StatesTaking people
- National Research InstituteLos Angeles, United StatesNo longer taking part
- University HospitalMadison, United StatesTaking people
- Le Bonheur Children's HospitalMemphis, United StatesNo longer taking part
- Le Bonheur Children's Hospital - Outpatient BuildingMemphis, United StatesNo longer taking part
- Le Bonheur Childrens Hospital - Childrens Foundation Research InstituteMemphis, United StatesNo longer taking part
- South Florida Research Phase I-IV, IncMiami, United StatesTaking people
- AppleMed Research Group, LLCMiami, United StatesNo longer taking part
- Brainstorm ResearchMiami, United StatesNo longer taking part
- Medical Research Center of Miami II, IncMiami, United StatesNo longer taking part
- NYU Langone Hospital-Long Island, Clinical Research CenterMineola, United StatesNo longer taking part
- NYU Langone Hospital-Long Island, Pediatric NeurologyMineola, 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
- Aqualane Clinical ResearchNaples, United StatesTaking people
- Advanced Research for Health Improvement, LLC/ Dr. Cordero's Pediatric OfficeNaples, United StatesNo longer taking part
- Access Clinical Trials, IncNashville, United StatesNo longer taking part
- HMH Jersey Shore University Medical CenterNeptune City, United StatesTaking people
- HOPE Tower at Jersey Shore University Medical CenterNeptune City, United StatesTaking people
- Ochsner Clinic FoundationNew Orleans, United StatesNo longer taking part
- New York Neurology AssociatesNew York, United StatesTaking people
- Weill Cornell MedicineNew York, United StatesTaking people
- Columbia University Medical Center Research PharmacyNew York, United StatesNo longer taking part
- Columbia University Pediatric Neuromuscular 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
- The Trustees of Columbia University and The New York and Presbyterian HospitalNew York, United StatesNo longer taking part
- Children's Hospital of The King's DaughtersNorfolk, United StatesTaking people
- CHKD Health CenterNorfolk, United StatesTaking people
- Neuro-Behavioral Clinical Research Inc.North Canton, United StatesNo longer taking part
- 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
- Children's Hospital of Orange CountyOrange, United StatesNot yet recruiting
- Children's Hospital of Orange County - Inpatient PharmacyOrange, United StatesNot yet recruiting
- Children's Hospital of Orange County - Neuroscience CenterOrange, United StatesNot yet recruiting
- Coastal Clinical Research SpecialistsOrange Park, United StatesNo longer taking part
- Clinical Associates of Orlando, LLCOrlando, United StatesTaking people
- College Park Family Care Center Physicians Group- Neurology Research Dept.Overland Park, United StatesNo longer taking part
- Sharlin Health Neuroscience Research CenterOzark, United StatesNo longer taking part
- Bioresearch InstitutePembroke Pines, United StatesNo longer taking part
- ClarioPhiladelphia, United StatesTaking people
- Children's Hospital of PhiladelphiaPhiladelphia, United StatesNo longer taking part
- Aim Trials, LLCPlano, United StatesNo longer taking part
- The Neurology GroupPomona, United StatesTaking people
- North Suffolk Neurology P.CPort Jefferson Station, United StatesNo longer taking part
- Providence Neuroscience Institute - Research Coordinator's OfficePortland, United StatesTaking people
- Providence St. Vincent Medical CenterPortland, United StatesTaking people
- National Clinical Research, IncRichmond, United StatesNo longer taking part
- Brackenridge Outpatient Research PharmacyRochester, United StatesTaking people
- Clinical Research Trials UnitRochester, United StatesTaking people
- Mayo ClinicRochester, United StatesTaking people
- Finger Lakes Clinical ResearchRochester, United StatesNo longer taking part
- Beaumont Hospital Royal Oak CampusRoyal Oak, United StatesNo longer taking part
- 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 (CCRC)Sacramento, 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, San BernardinoSan 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
- Neurology and Headache Center, Inc.Shreveport, United StatesNo longer taking part
- Velocity Clinical Research - Sioux CitySioux City, 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
- Prime Global Research, LLCThe Bronx, United StatesNo longer taking part
- Lynn Institute of TulsaTulsa, 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 ServicesWest 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
- Nemours Children's Hospital DelawareWilmington, United StatesNo longer taking part
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT04649242EU 2024-512743-23-00
- Record updated
- 27 October 2026
- Original description
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.Read full original descriptionShow less
Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age
The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.
Inclusion: History of migraine (with or without aura) for > 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s); History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting > 3 hours without treatment, and attacks occurring at intervals > 24 hours; Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study; Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists [biologic or small molecule], during the treatment phases; Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited; Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit; Verbally distinguish between migraine and other types of headaches; Participants must have a weight > 40 kg at the Screening Visit; Adequate venous access for blood sampling; Male and female participants ≥ 6 to < 18 years of age (participants must not reach their 18th birthday during the study).
Exclusion: Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania; Recent or planned surgery, requiring general anesthesia, <8 weeks prior to the Screening Visit; Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding); History of cluster headache or hemiplegic migraine headache; Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study; History of suicidal behavior or major psychiatric disorder; Current diagnosis or history of substance abuse; positive drug test at Screening; History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning; Current diagnosis of viral hepatitis or a history of liver disease; Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy.