ClinicalTrials.gg
RecruitingNCT04743141Updated Oct 27, 2026

Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine

A Phase 3 interventional study of Rimegepant (PF-07899801) in Acute Treatment of Migraine, sponsored by Pfizer. Recruiting at 124 sites in 3 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-10-27.

Sponsored by Pfizer · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Apr 2021; still recruiting 5 years 6 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
600
Allocation
Not applicable
Ages
6 Years to 17 Years
Sex
All
01

Study 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).

02

Conditions studied

  • Acute Treatment of Migraine

Keywords

  • Long-term safety, acute treatment, migraine, phonophobia, photophobia, nausea, pediatric, children, adolescent
03

In context

Migraine Disorders

1,657 studies on the registry are indexed under Migraine Disorders; 339 are open to participants now.

This study's planned enrollment of 600 is above the median of 80 across 1,269 interventional studies indexed under Migraine Disorders.

Browse Migraine Disorders studies →

Lead sponsor

Pfizer is the lead sponsor of 3,334 studies on the registry; 149 are open to participants now.

Of its 601 completed or terminated interventional studies of FDA-regulated products, 391 (65%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
6 Years to 17 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  1. History of migraine (with or without aura) for ≥ 6 months before Screening.
  2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.
  3. 1 or more migraine days requiring treatment during the Observation Phase.
  4. Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.
  5. Ability to distinguish between migraine and other types of headaches.
  6. Weight > 15 kg. For EU countries only: Participants 12 to \< 18 years of age must have a body weight of >25kg.
  7. Adequate venous access for blood sampling.
  8. Male and female participants 6 to \< 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).

Exclusion criteria

Exclusion Criteria:

  1. History of cluster headache or hemiplegic migraine headache.
  2. Confounding and pain syndrome.
  3. 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).
  4. History of suicidal behavior or at risk of self-harm/harm to others.
  5. History of major psychiatric disorder.
  6. Current diagnosis or history of substance abuse
  7. Reported current use of or tested positive at Screening for drugs of abuse.
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Clinically significant

Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
600 participants (estimated)

Study arms

  • Experimental
    Active

    rimegepant 75 mg, 50 mg or 35 mg ODT

    Drug: Rimegepant (PF-07899801)

Interventions

06

What researchers measure

Primary outcomes

  1. 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).

    Time frame: 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.

    Time frame: 58 weeks

07

Study locations

61 of 124 sites recruiting
  • Perseverance Research Center, LLC
    Scottsdale, Arizona 85253, United States
    Recruiting
  • Physicians Research Group
    Tempe, Arizona 85284, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Advanced Research Center, Inc.
    Anaheim, California 92805, United States
    Recruiting
  • ProScience Research Group
    Culver City, California 90230, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Neuro-Pain Research Center
    Fresno, California 93710, United States
    Recruiting
  • Altman Clinical and Translational Research Institute, University of California San Diego
    La Jolla, California 93037, United States
    Recruiting
  • Adult & Child Neurology Medical Associates
    Long Beach, California 90806, United States
    Recruiting
  • Memorialcare Miller Children's & Women's Hospital Long Beach
    Long Beach, California 90806, United States
    Recruiting
  • Velocity Clinical Research - North Hollywood
    North Hollywood, California 91606, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The Neurology Group
    Pomona, California 91767, United States
    Recruiting
  • UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
    Sacramento, California 95817, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • University of California, Davis Clinical and Translational Science Center Clinical Research Center
    Sacramento, California 95817, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • University of California, Davis Midtown Clinic
    Sacramento, California 95817, United States
    Active, not recruiting

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  • Velocity Clinical Research- Banning
    San Bernardino, California 92408, United States
    Active, not recruiting

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  • Pacific Clinical Research Management Group LLC
    Upland, California 91786, United States
    Active, not recruiting

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  • Sunwise Clinical Research
    Walnut Creek, California 94596, United States
    Recruiting
  • Children's Hospital Colorado- Investigational Drug Services
    Aurora, Colorado 80045, United States
    Recruiting
  • Children's Hospital Colorado
    Aurora, Colorado 80045, United States
    Recruiting
  • Colorado Springs Neurological Associates, PC
    Colorado Springs, Colorado 80907, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Colorado Springs Neurological Associates, PC
    Colorado Springs, Colorado 80919, United States
    Active, not recruiting

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  • Boeson Research GJT
    Grand Junction, Colorado 81501, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Dinosaur Pediatrics
    Grand Junction, Colorado 81501, United States
    Terminated

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  • Boeson Research GJT
    Grand Junction, Colorado 81505, United States
    Terminated

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  • CT Clinical Research
    Cromwell, Connecticut 06416, United States
    Recruiting
  • Ki Health Partners, LLc, dba New England Institute for Clinical Research
    Stamford, Connecticut 06905, United States
    Recruiting
  • Children's National Medical Center
    Washington D.C., District of Columbia 20010, United States
    Recruiting
  • AppleMed Research Group, LLC
    Miami, Florida 33126, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Medical Research Center of Miami II, Inc
    Miami, Florida 33134, United States
    Active, not recruiting

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  • South Florida Research Phase I-IV, Inc
    Miami, Florida 33166, United States
    Recruiting
  • Physicians Group Services, PA d/b/a Coastal Health Research
    Orange Park, Florida 32073, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Clinical Associates of Orlando, LLC
    Orlando, Florida 32819, United States
    Recruiting
  • ForCare Clinical Research
    Tampa, Florida 33613, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Premiere Research Institute at Palm Beach Neurology
    West Palm Beach, Florida 33407, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Rare Disease Research LLC
    Atlanta, Georgia 30329, United States
    Active, not recruiting

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  • Pivotal Clinical Research & Associates, LLC
    Brunswick, Georgia 31520, United States
    Active, not recruiting

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  • CenExel iResearch, LLC
    Decatur, Georgia 30030, United States
    Recruiting
  • Chicago Headache Center & Research Institute
    Chicago, Illinois 60657, United States
    Recruiting
  • AMR-Baber Research Inc
    Naperville, Illinois 60563, United States
    Recruiting
  • Options Research Group, LLC
    Westfield, Indiana 46074, United States
    Recruiting
  • Integrated Clinical Trial Services, Inc.
    West Des Moines, Iowa 50265, United States
    Recruiting
  • Clinical Associates Midwest, LLC
    Kansas City, Kansas 66214, United States
    Recruiting
  • University of Kentucky Hospital
    Lexington, Kentucky 40536, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Ochsner Clinic Foundation
    New Orleans, Louisiana 70121, United States
    Terminated

    Not enrolling at this site — choose another above.

  • MedVadis Research Corporation
    Waltham, Massachusetts 02451, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Michigan Head Pain and Neurological Institute
    Ann Arbor, Michigan 48104, United States
    Recruiting
  • Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group
    Grand Rapids, Michigan 49503, United States
    Recruiting
  • Corewell Health, Helen DeVos Children's Hospital
    Grand Rapids, Michigan 49503, United States
    Recruiting
  • Wellnow Urgent Care and Research
    Kalamazoo, Michigan 49048, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Beaumont Hospital, Royal Oak Campus
    Royal Oak, Michigan 48073, United States
    Recruiting
  • Sharlin Health Neuroscience Research Center
    Ozark, Missouri 65721, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Clinvest Research, LLC
    Springfield, Missouri 65807, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Boeson Research
    Great Falls, Montana 59405, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Heart & Hands Midwifery
    Kalispell, Montana 59901, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Blue Moose Pediatrics
    Missoula, Montana 59804, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Boeson Research Laboratory
    Missoula, Montana 59804, United States
    Active, not recruiting

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  • Boeson Research
    Missoula, Montana 59804, United States
    Active, not recruiting

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  • Alivation Research, LLC
    Lincoln, Nebraska 68526, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Children's Hospital & Medical Center
    Omaha, Nebraska 68114, United States
    Recruiting
  • HMH Jersey Shore University Medical Center
    Neptune City, New Jersey 07753, United States
    Recruiting
  • Hope Tower
    Neptune City, New Jersey 07753, United States
    Recruiting
  • Dent Neurosciences Research Center
    Amherst, New York 14226, United States
    Recruiting
  • True North Neurology
    Commack, New York 11725, United States
    Recruiting
  • New York Neurology Associates
    New York, New York 10003, United States
    Recruiting
  • Mount Sinai Hospital - Pharmacy Department
    New York, New York 10029, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Columbia University Irving Medical Center
    New York, New York 10032, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
    New York, New York 10032, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • The Neurological Institute of New York
    New York, New York 10032, United States
    Active, not recruiting

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  • North Suffolk Neurology
    Port Jefferson Station, New York 11776, United States
    Active, not recruiting

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  • OnSite Clinical Solutions, LLC
    Charlotte, North Carolina 28277, United States
    Recruiting
  • Headache Wellness Center, PC
    Greensboro, North Carolina 27405, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • WellNow Urgent Care and Research
    Cincinnati, Ohio 45215, United States
    Active, not recruiting

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  • Cincinnati Children's Hospital
    Cincinnati, Ohio 45229, United States
    Recruiting
  • Velocity Clinical Research - Cincinnati
    Cincinnati, Ohio 45242, United States
    Active, not recruiting

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  • University Hospitals Cleveland Medical Center
    Cleveland, Ohio 44106, United States
    Recruiting
  • Wellnow Urgent Care and Research
    Dayton, Ohio 45424, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • IPS Research Company
    Oklahoma City, Oklahoma 73106, United States
    Active, not recruiting

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  • Velocity Clinical Research, Grants Pass
    Grants Pass, Oregon 97527, United States
    Active, not recruiting

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  • Providence Neuroscience Institute: Research Coordinators' Office
    Portland, Oregon 97225, United States
    Recruiting
  • Providence Pediatric Specialty Clinic
    Portland, Oregon 97225, United States
    Recruiting
  • Clario
    Philadelphia, Pennsylvania 19103, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Children's Hospital of Philadelphia
    Philadelphia, Pennsylvania 19104, United States
    Active, not recruiting

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  • Velocity Clinical Research-Providence
    East Greenwich, Rhode Island 02818, United States
    Recruiting
  • Velocity Clinical Research- Greenville
    Greenville, South Carolina 29615, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Premier Neurology
    Greer, South Carolina 29650, United States
    Active, not recruiting

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  • Novaceut Clinical Research
    Clarksville, Tennessee 37043, United States
    Active, not recruiting

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  • Le Bonheur Children's Hospital
    Memphis, Tennessee 37103, United States
    Active, not recruiting

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  • Le Bonheur Childrens Hospital - Childrens Foundation Research Institute
    Memphis, Tennessee 38103, United States
    Active, not recruiting

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  • Le Bonheur Childrens Hospital - Outpatient Building
    Memphis, Tennessee 38103, United States
    Active, not recruiting

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  • Access Clinical Trials, Inc.
    Nashville, Tennessee 37203, United States
    Terminated

    Not enrolling at this site — choose another above.

  • Dell Children's Medical Center
    Austin, Texas 78723, United States
    Recruiting
  • Child Neurology Consultants of Austin - South Austin
    Austin, Texas 78749, United States
    Active, not recruiting

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  • Child Neurology Consultants of Austin - Central Austin
    Austin, Texas 78757, United States
    Recruiting
  • Houston Clinical Trials, LLC
    Bellaire, Texas 77401, United States
    Recruiting
  • Infinite Research Group, LLC
    Dallas, Texas 75201, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Cedar Health Research
    Dallas, Texas 75251, United States
    Active, not recruiting

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  • ANESC Research
    El Paso, Texas 79912, United States
    Recruiting
  • North Texas Institute of Neurology and Headache
    Frisco, Texas 75034, United States
    Active, not recruiting

    Not enrolling at this site — choose another above.

  • Trio Clinical Trials, LLC.
    Houston, Texas 77008, United States
    Active, not recruiting

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  • Pain and Headache Centers of Texas
    Houston, Texas 77054, United States
    Recruiting
  • SCLA Management
    Houston, Texas 77077, United States
    Recruiting

Showing the first 100 of 124 sites across 3 countries. Choose a country and city above to see the rest.

08

References and documents

Individual participant data

Plan to share: 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.

Data sharing details ↗ · www.pfizer.com

09

Timeline

1 registry update since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Started Apr 2021 (actual). Primary completion is estimated for Jul 2030, 111 months after the start.

Of 114 industry-sponsored phase 3 interventional studies under Migraine Disorders, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 31. This study's planned 111 months is above that.

Counting every sponsor, half of 140 studies reached it within 19 months; a quarter within 12 and three quarters within 40.

How these figures are worked out, and which studies are left out of them.

Registered
Feb 4, 2021
First posted
Feb 8, 2021
StartActual
Apr 28, 2021
Primary completionEst.
Jul 31, 2030
CompletionEst.
Jul 31, 2030
Last update
Oct 27, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
Minor edits
Nothing that changes what the study is or who can join. Edited: verification date
1 update, last Oct 27, 2026
Show all 1 update
  1. Oct 27, 2026
    Minor edits only
    + 1 other change: verification date

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

10

Registry details

Key details

Study ID
NCT04743141
Lead sponsor
Pfizer
Responsible party
Sponsor
First posted
Feb 8, 2021
Start date
Apr 28, 2021
Primary completion
Jul 31, 2030 (estimated)
Completion
Jul 31, 2030 (estimated)
Last update
Oct 27, 2026

Study contacts

Pfizer Pfizer CT.gov Call Center
Contact
ClinicalTrials.gov_Inquiries@pfizer.com
1-800-718-1021
Pfizer CT.gov Call Center
study director · Pfizer

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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