Acute Treatment of MigrainePhase 3NCT04743141
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
A Phase 3 study testing Rimegepant (PF-07899801) in people with Acute Treatment of Migraine, run by Pfizer at 124 sites in 3 countries.
Trial 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). Read more about this study
- Who is it for?
- Ages 6 to 17 years
- Conditions the study is for
- Acute Treatment of Migraine
- What is being tested?
- Rimegepant (PF-07899801)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 600 participants
- Where
- 124 sitesin 3 countries
- Study dates
- 28 Apr 2021to 31 Jul 2030
- Phase
- Phase 3
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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 join
- 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.
Trial locations and contacts
124 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
124 sites in 3 countries
United States115 sites, 55 recruiting
- Recruiting
Dent Neurosciences Research Center
Amherst, New York, 14226
- Recruiting
Advanced Research Center, Inc.
Anaheim, California, 92805
- Recruiting
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, 48104
- Active, not recruiting
Rare Disease Research LLC
Atlanta, Georgia, 30329
- Recruiting
Children's Hospital Colorado- Investigational Drug Services
Aurora, Colorado, 80045
- Recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
- Recruiting
Dell Children's Medical Center
Austin, Texas, 78723
- Active, not recruiting
Child Neurology Consultants of Austin - South Austin
Austin, Texas, 78749
- Recruiting
Child Neurology Consultants of Austin - Central Austin
Austin, Texas, 78757
- Recruiting
Houston Clinical Trials, LLC
Bellaire, Texas, 77401
- Recruiting
Northwest Clinical Research Center
Bellevue, Washington, 98007
- Active, not recruiting
Pivotal Clinical Research & Associates, LLC
Brunswick, Georgia, 31520
- Recruiting
OnSite Clinical Solutions, LLC
Charlotte, North Carolina, 28277
- Recruiting
Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
Charlottesville, Virginia, 22902
- Recruiting
Pediatric Research of Charlottesville, LLC (Regulatory Only)
Charlottesville, Virginia, 22902
- Recruiting
Pediatric Research of Charlottesville, LLC
Charlottesville, Virginia, 22902
- Recruiting
Chicago Headache Center & Research Institute
Chicago, Illinois, 60657
- Active, not recruiting
WellNow Urgent Care and Research
Cincinnati, Ohio, 45215
- Recruiting
Cincinnati Children's Hospital
Cincinnati, Ohio, 45229
- Active, not recruiting
Velocity Clinical Research - Cincinnati
Cincinnati, Ohio, 45242
- Active, not recruiting
Novaceut Clinical Research
Clarksville, Tennessee, 37043
- Recruiting
University Hospitals Cleveland Medical Center
Cleveland, Ohio, 44106
- Active, not recruiting
Colorado Springs Neurological Associates, PC
Colorado Springs, Colorado, 80907
- Active, not recruiting
Colorado Springs Neurological Associates, PC
Colorado Springs, Colorado, 80919
- Recruiting
True North Neurology
Commack, New York, 11725
- Recruiting
CT Clinical Research
Cromwell, Connecticut, 06416
- Active, not recruiting
ProScience Research Group
Culver City, California, 90230
- Active, not recruiting
Infinite Research Group, LLC
Dallas, Texas, 75201
- Active, not recruiting
Cedar Health Research
Dallas, Texas, 75251
- Active, not recruiting
Wellnow Urgent Care and Research
Dayton, Ohio, 45424
- Recruiting
CenExel iResearch, LLC
Decatur, Georgia, 30030
- Recruiting
Velocity Clinical Research-Providence
East Greenwich, Rhode Island, 02818
- Recruiting
ANESC Research
El Paso, Texas, 79912
- Recruiting
Neuro-Pain Research Center
Fresno, California, 93710
- Active, not recruiting
North Texas Institute of Neurology and Headache
Frisco, Texas, 75034
- Terminated
Boeson Research GJT
Grand Junction, Colorado, 81501
- Terminated
Dinosaur Pediatrics
Grand Junction, Colorado, 81501
- Terminated
Boeson Research GJT
Grand Junction, Colorado, 81505
- Recruiting
Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group
Grand Rapids, Michigan, 49503
- Recruiting
Corewell Health, Helen DeVos Children's Hospital
Grand Rapids, Michigan, 49503
- Active, not recruiting
Velocity Clinical Research, Grants Pass
Grants Pass, Oregon, 97527
- Active, not recruiting
Boeson Research
Great Falls, Montana, 59405
- Active, not recruiting
Headache Wellness Center, PC
Greensboro, North Carolina, 27405
- Active, not recruiting
Velocity Clinical Research- Greenville
Greenville, South Carolina, 29615
- Active, not recruiting
Premier Neurology
Greer, South Carolina, 29650
- Active, not recruiting
Trio Clinical Trials, LLC.
Houston, Texas, 77008
- Recruiting
Pain and Headache Centers of Texas
Houston, Texas, 77054
- Recruiting
SCLA Management
Houston, Texas, 77077
- Terminated
Houston Clinical Research,LLC.
Houston, Texas, 77081
- Recruiting
NeuroCare Plus
Houston, Texas, 77094
- Terminated
Wellnow Urgent Care and Research
Kalamazoo, Michigan, 49048
- Active, not recruiting
Heart & Hands Midwifery
Kalispell, Montana, 59901
- Recruiting
Clinical Associates Midwest, LLC
Kansas City, Kansas, 66214
- Recruiting
Altman Clinical and Translational Research Institute, University of California San Diego
La Jolla, California, 93037
- Active, not recruiting
University of Kentucky Hospital
Lexington, Kentucky, 40536
- Terminated
Alivation Research, LLC
Lincoln, Nebraska, 68526
- Recruiting
Adult & Child Neurology Medical Associates
Long Beach, California, 90806
- Recruiting
Memorialcare Miller Children's & Women's Hospital Long Beach
Long Beach, California, 90806
- Recruiting
University Hospital
Madison, Wisconsin, 53792
- Active, not recruiting
Le Bonheur Children's Hospital
Memphis, Tennessee, 37103
- Active, not recruiting
Le Bonheur Childrens Hospital - Childrens Foundation Research Institute
Memphis, Tennessee, 38103
- Active, not recruiting
Le Bonheur Childrens Hospital - Outpatient Building
Memphis, Tennessee, 38103
- Active, not recruiting
AppleMed Research Group, LLC
Miami, Florida, 33126
- Active, not recruiting
Medical Research Center of Miami II, Inc
Miami, Florida, 33134
- Recruiting
South Florida Research Phase I-IV, Inc
Miami, Florida, 33166
- Active, not recruiting
Blue Moose Pediatrics
Missoula, Montana, 59804
- Active, not recruiting
Boeson Research Laboratory
Missoula, Montana, 59804
- Active, not recruiting
Boeson Research
Missoula, Montana, 59804
- Recruiting
AMR-Baber Research Inc
Naperville, Illinois, 60563
- Terminated
Access Clinical Trials, Inc.
Nashville, Tennessee, 37203
- Recruiting
HMH Jersey Shore University Medical Center
Neptune City, New Jersey, 07753
- Recruiting
Hope Tower
Neptune City, New Jersey, 07753
- Terminated
Ochsner Clinic Foundation
New Orleans, Louisiana, 70121
- Recruiting
New York Neurology Associates
New York, New York, 10003
- Active, not recruiting
Mount Sinai Hospital - Pharmacy Department
New York, New York, 10029
- Active, not recruiting
Columbia University Irving Medical Center
New York, New York, 10032
- Active, not recruiting
Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
New York, New York, 10032
- Active, not recruiting
The Neurological Institute of New York
New York, New York, 10032
- Recruiting
Children's Hospital of The King's Daughters
Norfolk, Virginia, 23507
- Recruiting
CHKD Health Center
Norfolk, Virginia, 23510
- Active, not recruiting
Velocity Clinical Research - North Hollywood
North Hollywood, California, 91606
- Active, not recruiting
IPS Research Company
Oklahoma City, Oklahoma, 73106
- Recruiting
Children's Hospital & Medical Center
Omaha, Nebraska, 68114
- Active, not recruiting
Physicians Group Services, PA d/b/a Coastal Health Research
Orange Park, Florida, 32073
- Recruiting
Clinical Associates of Orlando, LLC
Orlando, Florida, 32819
- Active, not recruiting
Sharlin Health Neuroscience Research Center
Ozark, Missouri, 65721
- Active, not recruiting
Clario
Philadelphia, Pennsylvania, 19103
- Active, not recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
- Active, not recruiting
AIM Trials, LLC
Plano, Texas, 75093
- Recruiting
The Neurology Group
Pomona, California, 91767
- Active, not recruiting
North Suffolk Neurology
Port Jefferson Station, New York, 11776
- Recruiting
Providence Neuroscience Institute: Research Coordinators' Office
Portland, Oregon, 97225
- Recruiting
Providence Pediatric Specialty Clinic
Portland, Oregon, 97225
- Terminated
National Clinical Research, Inc.
Richmond, Virginia, 23294
- Recruiting
Beaumont Hospital, Royal Oak Campus
Royal Oak, Michigan, 48073
- Active, not recruiting
UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
Sacramento, California, 95817
- Active, not recruiting
University of California, Davis Clinical and Translational Science Center Clinical Research Center
Sacramento, California, 95817
- Active, not recruiting
University of California, Davis Midtown Clinic
Sacramento, California, 95817
- Recruiting
JBR Clinical Research
Salt Lake City, Utah, 84107
- Recruiting
Wasatch Clinical Research , LLC(Administrative Location)
Salt Lake City, Utah, 84107
- Active, not recruiting
Velocity Clinical Research- Banning
San Bernardino, California, 92408
- Recruiting
Perseverance Research Center, LLC
Scottsdale, Arizona, 85253
- Recruiting
Seattle Children's Hospital Investigational Drug Services
Seattle, Washington, 98105
- Recruiting
Seattle Children's Hospital
Seattle, Washington, 98105
- Active, not recruiting
Clinvest Research, LLC
Springfield, Missouri, 65807
- Recruiting
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, 06905
- Active, not recruiting
ForCare Clinical Research
Tampa, Florida, 33613
- Active, not recruiting
Physicians Research Group
Tempe, Arizona, 85284
- Active, not recruiting
Pacific Clinical Research Management Group LLC
Upland, California, 91786
- Recruiting
Sunwise Clinical Research
Walnut Creek, California, 94596
- Active, not recruiting
MedVadis Research Corporation
Waltham, Massachusetts, 02451
- Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, 20010
- Recruiting
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, 50265
- Active, not recruiting
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, 33407
- Recruiting
Options Research Group, LLC
Westfield, Indiana, 46074
Poland6 sites, 4 recruiting
- Terminated
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
Katowice, 40-123
- Recruiting
Centrum Medyczne Plejady
Krakow, 30-363
- Recruiting
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci
Krakow, 31-503
- Recruiting
Clinical Research Center Sp. z o.o.
Poznan, 60-848
- Recruiting
Pracownia Badan Klinicznych SALUS
Wroclaw, 52-210
- Active, not recruiting
Centrum Medyczne Oporow
Wroclaw, 52-416
Spain3 sites, 2 recruiting
- Active, not recruiting
Centre Atencio Primaria (CAP) Balenya
Balenya, Barcelona, 08550
- Recruiting
Hospital Universitario Vall d'Hebron
Barcelona, 08035
- Recruiting
Hospital Clinico Universitario de Valladolid
Valladolid, 47003
About this study
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
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).
- Conditions
- Acute Treatment of Migraine
- Being tested
- Rimegepant (PF-07899801)
- Keywords
- Long-term safety, acute treatment, migraine, phonophobia, photophobia, nausea, pediatric, children, adolescent
- Medical subject headings
- Migraine Disorders, Hyperacusis, Photophobia, Nausea
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Rimegepant (PF-07899801)Drug
Rimegepant 75 mg, 50 mg or 35 mg ODT
| Study group | Role | What they receive |
|---|---|---|
| Active | Experimental | rimegepant 75 mg, 50 mg or 35 mg ODT Receives: Drug: Rimegepant (PF-07899801) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities
To evaluate the safety and tolerability of rimegepant in children and adolescents (6 to < 18 years of age).
Measured: 58 weeks
Secondary outcomes (1)
The frequency and severity of hepatic-related adverse events and frequency of hepatic-related adverse events leading to treatment discontinuation
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.
Measured: 58 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Feb 2021
- Study start28 Apr 2021
- Primary completion31 Jul 2030 (estimated)
- Study completion31 Jul 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Treatment of MigraineStudies of the same condition, open and under way.
- More trials run by PfizerThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Pfizer
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pfizer CT.gov Call Center, Study director, Pfizer
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04743141
- Sponsor's protocol ID
- BHV3000-312
- Other IDs
- C4951003, 2024-512744-32-00
- Status last verified
- Sep 2026
- First submitted
- 4 Feb 2021
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.