Recruiting

Phase 3

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

Sponsor:

Pfizer

Code:

NCT04743141

Conditions

Acute Treatment of Migraine

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

Interventions

Rimegepant (PF-07899801)

Study Details

Brief 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).

Conditions

Acute Treatment of Migraine

Study ID

NCT04743141

Start date

Apr 28, 2021

Status verified date

Aug, 2026

Completion date

Jul 31, 2030

Anticipated

Primary completion date

Jul 31, 2030

Anticipated

Eligibility Criteria

Sex: All

Age: 6 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

600 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Active

rimegepant 75 mg, 50 mg or 35 mg ODT

Interventions

Rimegepant (PF-07899801)

Rimegepant 75 mg, 50 mg or 35 mg ODT

Primary outcome measure

The frequency and severity of on-treatment and treatment-emergent adverse events, serious adverse events, adverse events leading to discontinuation, clinically significant lab abnormalities [ Time Frame: 58 weeks ]

Central Contacts and Locations

Central contacts

Pfizer Pfizer CT.gov Call Center

1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com

Locations

Perseverance Research Center, LLC

Recruiting

Scottsdale, Arizona, United States, 85253

Advanced Research Center, Inc.

Recruiting

Anaheim, California, United States, 92805

Neuro-Pain Research Center

Recruiting

Fresno, California, United States, 93710

Altman Clinical and Translational Research Institute, University of California San Diego

Recruiting

La Jolla, California, United States, 93037

Adult & Child Neurology Medical Associates

Recruiting

Long Beach, California, United States, 90806

Memorialcare Miller Children's & Women's Hospital Long Beach

Recruiting

Long Beach, California, United States, 90806

The Neurology Group

Recruiting

Pomona, California, United States, 91767

Velocity Clinical Research- Banning

Recruiting

San Bernardino, California, United States, 92408

Sunwise Clinical Research

Recruiting

Walnut Creek, California, United States, 94596

Children's Hospital Colorado- Investigational Drug Services

Recruiting

Aurora, Colorado, United States, 80045

Children's Hospital Colorado

Recruiting

Aurora, Colorado, United States, 80045

CT Clinical Research

Recruiting

Cromwell, Connecticut, United States, 06416

Ki Health Partners, LLc, dba New England Institute for Clinical Research

Recruiting

Stamford, Connecticut, United States, 06905

Children's National Medical Center

Recruiting

Washington D.C., District of Columbia, United States, 20010

South Florida Research Phase I-IV, Inc

Recruiting

Miami, Florida, United States, 33166

Clinical Associates of Orlando, LLC

Recruiting

Orlando, Florida, United States, 32819

Pivotal Clinical Research & Associates, LLC

Recruiting

Brunswick, Georgia, United States, 31520

CenExel iResearch, LLC

Recruiting

Decatur, Georgia, United States, 30030

Chicago Headache Center & Research Institute

Recruiting

Chicago, Illinois, United States, 60657

AMR-Baber Research Inc

Recruiting

Naperville, Illinois, United States, 60563

Options Research Group, LLC

Recruiting

Westfield, Indiana, United States, 46074

Integrated Clinical Trial Services, Inc.

Recruiting

West Des Moines, Iowa, United States, 50265

Clinical Associates Midwest, LLC

Recruiting

Kansas City, Kansas, United States, 66214

Michigan Head Pain and Neurological Institute

Recruiting

Ann Arbor, Michigan, United States, 48104

Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group

Recruiting

Grand Rapids, Michigan, United States, 49503

Corewell Health, Helen DeVos Children's Hospital

Recruiting

Grand Rapids, Michigan, United States, 49503

Beaumont Hospital, Royal Oak Campus

Recruiting

Royal Oak, Michigan, United States, 48073

Boeson Research

Recruiting

Great Falls, Montana, United States, 59405

Blue Moose Pediatrics

Recruiting

Missoula, Montana, United States, 59804

Boeson Research Laboratory

Recruiting

Missoula, Montana, United States, 59804

Boeson Research

Recruiting

Missoula, Montana, United States, 59804

Children's Hospital & Medical Center

Recruiting

Omaha, Nebraska, United States, 68114

HMH Jersey Shore University Medical Center

Recruiting

Neptune City, New Jersey, United States, 07753

Hope Tower

Recruiting

Neptune City, New Jersey, United States, 07753

Dent Neurosciences Research Center

Recruiting

Amherst, New York, United States, 14226

True North Neurology

Recruiting

Commack, New York, United States, 11725

New York Neurology Associates

Recruiting

New York, New York, United States, 10003

OnSite Clinical Solutions, LLC

Recruiting

Charlotte, North Carolina, United States, 28277

Cincinnati Children's Hospital

Recruiting

Cincinnati, Ohio, United States, 45229

University Hospitals Cleveland Medical Center

Recruiting

Cleveland, Ohio, United States, 44106

Providence Neuroscience Institute: Research Coordinators' Office

Recruiting

Portland, Oregon, United States, 97225

Providence Pediatric Specialty Clinic

Recruiting

Portland, Oregon, United States, 97225

Velocity Clinical Research-Providence

Recruiting

East Greenwich, Rhode Island, United States, 02818

Dell Children's Medical Center

Recruiting

Austin, Texas, United States, 78723

Child Neurology Consultants of Austin - Central Austin

Recruiting

Austin, Texas, United States, 78757

Houston Clinical Trials, LLC

Recruiting

Bellaire, Texas, United States, 77401

ANESC Research

Recruiting

El Paso, Texas, United States, 79912

Pain and Headache Centers of Texas

Recruiting

Houston, Texas, United States, 77054

SCLA Management

Recruiting

Houston, Texas, United States, 77077

NeuroCare Plus

Recruiting

Houston, Texas, United States, 77094

JBR Clinical Research

Recruiting

Salt Lake City, Utah, United States, 84107

Wasatch Clinical Research , LLC(Administrative Location)

Recruiting

Salt Lake City, Utah, United States, 84107

Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice)

Recruiting

Charlottesville, Virginia, United States, 22902

Pediatric Research of Charlottesville, LLC (Regulatory Only)

Recruiting

Charlottesville, Virginia, United States, 22902

Pediatric Research of Charlottesville, LLC

Recruiting

Charlottesville, Virginia, United States, 22902

Children's Hospital of The King's Daughters

Recruiting

Norfolk, Virginia, United States, 23507

CHKD Health Center

Recruiting

Norfolk, Virginia, United States, 23510

Northwest Clinical Research Center

Recruiting

Bellevue, Washington, United States, 98007

Seattle Children's Hospital Investigational Drug Services

Recruiting

Seattle, Washington, United States, 98105

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98105

University Hospital

Recruiting

Madison, Wisconsin, United States, 53792

More Information

Sponsor

Pfizer

Last update posted

Aug 14, 2026

Last verified

Aug, 2026

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Pfizer on 2026-08-14.