Migraine drug rimegepant tested for safety in kids and teens

NCT ID NCT04743141

Symptom relief Sponsor: Pfizer Source: ClinicalTrials.gov ↗

First seen Jun 24, 2026 · Last updated Aug 14, 2026 · Updated 8 times

Summary

This study tests the long-term safety of rimegepant, a migraine medication taken as a dissolving tablet, in children and adolescents aged 6 to 18. About 600 participants with a history of migraine will take the drug as needed for up to one year. The main goal is to check for side effects, including liver-related issues.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance: rimegepant (a migraine medication taken as a dissolving tablet)
What this could lead to: If successful, this could provide a safe and effective treatment option for migraine attacks in children and teenagers.
What could go wrong: This is an open-label study focused on safety, not efficacy, so it won't prove how well the drug works. Side effects, especially liver-related, are being closely monitored.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 600 people

The number the study aims to enrol. It can still change while the study runs.

Started

Apr 2021

Expected to finish

Jul 2030

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

6 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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: 1. History of cluster headache or hemiplegic migraine headache. 2. Confounding and clinically significant 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.

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Conditions

The condition(s) this trial relates to.

hyperacusis migraine disorder Nausea Photophobia

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Acute treatment of migraine

How to take part

Only the study team decides who joins. These are the ways to reach them.

The places running it

67 sites in 3 countries. The list below names each one and where it is.
The official record

ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

Open the record ↗
A doctor treating you

A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

AIM Trials, LLC
ACTIVE_NOT_RECRUITING

Plano, Texas, 75093, United States
AMR-Baber Research Inc
RECRUITING

Naperville, Illinois, 60563, United States
ANESC Research
RECRUITING

El Paso, Texas, 79912, United States
Access Clinical Trials, Inc.
TERMINATED

Nashville, Tennessee, 37203, United States
Adult & Child Neurology Medical Associates
RECRUITING

Long Beach, California, 90806, United States
Advanced Research Center, Inc.
RECRUITING

Anaheim, California, 92805, United States
Alivation Research, LLC
TERMINATED

Lincoln, Nebraska, 68526, United States
Altman Clinical and Translational Research Institute, University of California San Diego
RECRUITING

La Jolla, California, 93037, United States
AppleMed Research Group, LLC
ACTIVE_NOT_RECRUITING

Miami, Florida, 33126, United States
Beaumont Hospital, Royal Oak Campus
RECRUITING

Royal Oak, Michigan, 48073, United States
Blue Moose Pediatrics
RECRUITING

Missoula, Montana, 59804, United States
Boeson Research
RECRUITING

Great Falls, Montana, 59405, United States
Boeson Research
RECRUITING

Missoula, Montana, 59804, United States
Boeson Research GJT
TERMINATED

Grand Junction, Colorado, 81501, United States
Boeson Research GJT
TERMINATED

Grand Junction, Colorado, 81505, United States
Boeson Research Laboratory
RECRUITING

Missoula, Montana, 59804, United States
CHKD Health Center
RECRUITING

Norfolk, Virginia, 23510, United States
CT Clinical Research
RECRUITING

Cromwell, Connecticut, 06416, United States
Cedar Health Research
ACTIVE_NOT_RECRUITING

Dallas, Texas, 75251, United States
CenExel iResearch, LLC
RECRUITING

Decatur, Georgia, 30030, United States
Centre Atencio Primaria (CAP) Balenya
ACTIVE_NOT_RECRUITING

Balenya, Barcelona, 08550, Spain
Centrum Medyczne Oporow
ACTIVE_NOT_RECRUITING

Wroclaw, 52-416, Poland
Centrum Medyczne Plejady
RECRUITING

Krakow, 30-363, Poland
Chicago Headache Center & Research Institute
RECRUITING

Chicago, Illinois, 60657, United States
Child Neurology Consultants of Austin - Central Austin
RECRUITING

Austin, Texas, 78757, United States
Child Neurology Consultants of Austin - South Austin
ACTIVE_NOT_RECRUITING

Austin, Texas, 78749, United States
Children's Hospital & Medical Center
RECRUITING

Omaha, Nebraska, 68114, United States
Children's Hospital Colorado
RECRUITING

Aurora, Colorado, 80045, United States
Children's Hospital Colorado- Investigational Drug Services
RECRUITING

Aurora, Colorado, 80045, United States
Children's Hospital of Philadelphia
ACTIVE_NOT_RECRUITING

Philadelphia, Pennsylvania, 19104, United States
Children's Hospital of The King's Daughters
RECRUITING

Norfolk, Virginia, 23507, United States
Children's National Medical Center
RECRUITING

Washington D.C., District of Columbia, 20010, United States
Cincinnati Children's Hospital
RECRUITING

Cincinnati, Ohio, 45229, United States
Clario
ACTIVE_NOT_RECRUITING

Philadelphia, Pennsylvania, 19103, United States
Clinical Associates Midwest, LLC
RECRUITING

Kansas City, Kansas, 66214, United States
Clinical Associates of Orlando, LLC
RECRUITING

Orlando, Florida, 32819, United States
Clinical Research Center Sp. z o.o.
RECRUITING

Poznan, 60-848, Poland
Clinvest Research, LLC
ACTIVE_NOT_RECRUITING

Springfield, Missouri, 65807, United States
Colorado Springs Neurological Associates, PC
ACTIVE_NOT_RECRUITING

Colorado Springs, Colorado, 80907, United States
Colorado Springs Neurological Associates, PC
ACTIVE_NOT_RECRUITING

Colorado Springs, Colorado, 80919, United States
Columbia University Irving Medical Center
ACTIVE_NOT_RECRUITING

New York, New York, 10032, United States
Corewell Health, Helen DeVos Children's Hospital
RECRUITING

Grand Rapids, Michigan, 49503, United States
Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group
RECRUITING

Grand Rapids, Michigan, 49503, United States
Dell Children's Medical Center
RECRUITING

Austin, Texas, 78723, United States
Dent Neurosciences Research Center
RECRUITING

Amherst, New York, 14226, United States
Dinosaur Pediatrics
TERMINATED

Grand Junction, Colorado, 81501, United States
ForCare Clinical Research
ACTIVE_NOT_RECRUITING

Tampa, Florida, 33613, United States
HMH Jersey Shore University Medical Center
RECRUITING

Neptune City, New Jersey, 07753, United States
Headache Wellness Center, PC
ACTIVE_NOT_RECRUITING

Greensboro, North Carolina, 27405, United States
Heart & Hands Midwifery
ACTIVE_NOT_RECRUITING

Kalispell, Montana, 59901, United States
Hope Tower
RECRUITING

Neptune City, New Jersey, 07753, United States
Hospital Clinico Universitario de Valladolid
RECRUITING

Valladolid, 47003, Spain
Hospital Universitario Vall d'Hebron
RECRUITING

Barcelona, 08035, Spain
Houston Clinical Research,LLC.
TERMINATED

Houston, Texas, 77081, United States
Houston Clinical Trials, LLC
RECRUITING

Bellaire, Texas, 77401, United States
IPS Research Company
ACTIVE_NOT_RECRUITING

Oklahoma City, Oklahoma, 73106, United States
Infinite Research Group, LLC
ACTIVE_NOT_RECRUITING

Dallas, Texas, 75201, United States
Integrated Clinical Trial Services, Inc.
RECRUITING

West Des Moines, Iowa, 50265, United States
Irving Center for Clinical and Translational Research, Outpatient Clinical Research Unit
ACTIVE_NOT_RECRUITING

New York, New York, 10032, United States
JBR Clinical Research
RECRUITING

Salt Lake City, Utah, 84107, United States
Ki Health Partners, LLc, dba New England Institute for Clinical Research
RECRUITING

Stamford, Connecticut, 06905, United States
Le Bonheur Children's Hospital
ACTIVE_NOT_RECRUITING

Memphis, Tennessee, 37103, United States
Le Bonheur Childrens Hospital - Childrens Foundation Research Institute
ACTIVE_NOT_RECRUITING

Memphis, Tennessee, 38103, United States
Le Bonheur Childrens Hospital - Outpatient Building
ACTIVE_NOT_RECRUITING

Memphis, Tennessee, 38103, United States
MedVadis Research Corporation
ACTIVE_NOT_RECRUITING

Waltham, Massachusetts, 02451, United States
Medical Research Center of Miami II, Inc
ACTIVE_NOT_RECRUITING

Miami, Florida, 33134, United States
Memorialcare Miller Children's & Women's Hospital Long Beach
RECRUITING

Long Beach, California, 90806, United States
Michigan Head Pain and Neurological Institute
RECRUITING

Ann Arbor, Michigan, 48104, United States
Mount Sinai Hospital - Pharmacy Department
ACTIVE_NOT_RECRUITING

New York, New York, 10029, United States
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS, Lech Szczechowski
TERMINATED

Katowice, 40-123, Poland
National Clinical Research, Inc.
TERMINATED

Richmond, Virginia, 23294, United States
Neuro-Pain Research Center
RECRUITING

Fresno, California, 93710, United States
NeuroCare Plus
RECRUITING

Houston, Texas, 77094, United States
New York Neurology Associates
RECRUITING

New York, New York, 10003, United States
North Suffolk Neurology
ACTIVE_NOT_RECRUITING

Port Jefferson Station, New York, 11776, United States
North Texas Institute of Neurology and Headache
ACTIVE_NOT_RECRUITING

Frisco, Texas, 75034, United States
Northwest Clinical Research Center
RECRUITING

Bellevue, Washington, 98007, United States
Novaceut Clinical Research
ACTIVE_NOT_RECRUITING

Clarksville, Tennessee, 37043, United States
Ochsner Clinic Foundation
TERMINATED

New Orleans, Louisiana, 70121, United States
OnSite Clinical Solutions, LLC
RECRUITING

Charlotte, North Carolina, 28277, United States
Options Research Group, LLC
RECRUITING

Westfield, Indiana, 46074, United States
Pacific Clinical Research Management Group LLC
ACTIVE_NOT_RECRUITING

Upland, California, 91786, United States
Pain and Headache Centers of Texas
RECRUITING

Houston, Texas, 77054, United States
Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)
RECRUITING

Charlottesville, Virginia, 22902, United States
Pediatric Research of Charlottesville, LLC
RECRUITING

Charlottesville, Virginia, 22902, United States
Pediatric Research of Charlottesville, LLC (Regulatory Only)
RECRUITING

Charlottesville, Virginia, 22902, United States
Perseverance Research Center, LLC
RECRUITING

Scottsdale, Arizona, 85253, United States
Physicians Group Services, PA d/b/a Coastal Health Research
ACTIVE_NOT_RECRUITING

Orange Park, Florida, 32073, United States
Physicians Research Group
ACTIVE_NOT_RECRUITING

Tempe, Arizona, 85284, United States
Pivotal Clinical Research & Associates, LLC
RECRUITING

Brunswick, Georgia, 31520, United States
Pracownia Badan Klinicznych SALUS
RECRUITING

Wroclaw, 52-210, Poland
Premier Neurology
ACTIVE_NOT_RECRUITING

Greer, South Carolina, 29650, United States
Premiere Research Institute at Palm Beach Neurology
ACTIVE_NOT_RECRUITING

West Palm Beach, Florida, 33407, United States
ProScience Research Group
ACTIVE_NOT_RECRUITING

Culver City, California, 90230, United States
Providence Neuroscience Institute: Research Coordinators' Office
RECRUITING

Portland, Oregon, 97225, United States
Providence Pediatric Specialty Clinic
RECRUITING

Portland, Oregon, 97225, United States
Rare Disease Research LLC
ACTIVE_NOT_RECRUITING

Atlanta, Georgia, 30329, United States
SCLA Management
RECRUITING

Houston, Texas, 77077, United States
Seattle Children's Hospital
RECRUITING

Seattle, Washington, 98105, United States
Seattle Children's Hospital Investigational Drug Services
RECRUITING

Seattle, Washington, 98105, United States
Sharlin Health Neuroscience Research Center
ACTIVE_NOT_RECRUITING

Ozark, Missouri, 65721, United States
South Florida Research Phase I-IV, Inc
RECRUITING

Miami, Florida, 33166, United States
Sunwise Clinical Research
RECRUITING

Walnut Creek, California, 94596, United States
The Neurological Institute of New York
ACTIVE_NOT_RECRUITING

New York, New York, 10032, United States
The Neurology Group
RECRUITING

Pomona, California, 91767, United States
Trio Clinical Trials, LLC.
ACTIVE_NOT_RECRUITING

Houston, Texas, 77008, United States
True North Neurology
RECRUITING

Commack, New York, 11725, United States
UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
ACTIVE_NOT_RECRUITING

Sacramento, California, 95817, United States
University Hospital
RECRUITING

Madison, Wisconsin, 53792, United States
University Hospitals Cleveland Medical Center
RECRUITING

Cleveland, Ohio, 44106, United States
University of California, Davis Clinical and Translational Science Center Clinical Research Center
ACTIVE_NOT_RECRUITING

Sacramento, California, 95817, United States
University of California, Davis Midtown Clinic
ACTIVE_NOT_RECRUITING

Sacramento, California, 95817, United States
University of Kentucky Hospital
ACTIVE_NOT_RECRUITING

Lexington, Kentucky, 40536, United States
Velocity Clinical Research - Cincinnati
ACTIVE_NOT_RECRUITING

Cincinnati, Ohio, 45242, United States
Velocity Clinical Research - North Hollywood
ACTIVE_NOT_RECRUITING

North Hollywood, California, 91606, United States
Velocity Clinical Research, Grants Pass
ACTIVE_NOT_RECRUITING

Grants Pass, Oregon, 97527, United States
Velocity Clinical Research- Banning
RECRUITING

San Bernardino, California, 92408, United States
Velocity Clinical Research- Greenville
ACTIVE_NOT_RECRUITING

Greenville, South Carolina, 29615, United States
Velocity Clinical Research-Providence
RECRUITING

East Greenwich, Rhode Island, 02818, United States
Wasatch Clinical Research , LLC(Administrative Location)
RECRUITING

Salt Lake City, Utah, 84107, United States
WellNow Urgent Care and Research
ACTIVE_NOT_RECRUITING

Cincinnati, Ohio, 45215, United States
Wellnow Urgent Care and Research
TERMINATED

Kalamazoo, Michigan, 49048, United States
Wellnow Urgent Care and Research
ACTIVE_NOT_RECRUITING

Dayton, Ohio, 45424, United States
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci
RECRUITING

Krakow, 31-503, Poland

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