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

NCT ID: NCT04743141
Registry status: Recruiting
Study type: Interventional
Phase: Phase 3
Sponsor: Pfizer
Conditions: Acute Treatment of Migraine

Overview

ClinicalTrials.gov lists this study as Recruiting.

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

Enrollment: 600 participants (Estimated).

What is being studied

Drug: Rimegepant (PF-07899801)
Intervention: rimegepant sulfate

Who may be eligible

Ages: 6 Years to 17 Years
Sex: All
Healthy volunteers accepted: No

ClinicalTrials.gov lists the following eligibility criteria.

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 locations

122 study locations are listed.

Recruiting site status is explicitly provided for 122 locations; 61 are listed as Recruiting.

Countries: Poland, Spain, United States

Barcelona, Spain: 1
Arizona, United States: 2
California, United States: 14
Colorado, United States: 5
Connecticut, United States: 2
District of Columbia, United States: 1
Florida, United States: 7
Georgia, United States: 3
Illinois, United States: 2
Indiana, United States: 1
Iowa, United States: 1
Kansas, United States: 1
Kentucky, United States: 1
Louisiana, United States: 1
Massachusetts, United States: 1
Michigan, United States: 5
Missouri, United States: 2
Montana, United States: 5
Nebraska, United States: 2
New Jersey, United States: 2
New York, United States: 8
North Carolina, United States: 2
Ohio, United States: 5
Oklahoma, United States: 1
Oregon, United States: 3
Pennsylvania, United States: 2
Rhode Island, United States: 1
South Carolina, United States: 2
Tennessee, United States: 5
Texas, United States: 14

Sample of listed locations

Centrum Medyczne Plejady — Krakow, 30-363, Poland — Recruiting
Wojewodzki Specjalistyczny Szpital Dzieciecy im. Sw. Ludwika w Krakowie Oddzial Kliniczny Dzieci — Krakow, 31-503, Poland — Recruiting
Clinical Research Center Sp. z o.o. — Poznan, 60-848, Poland — Recruiting
Pracownia Badan Klinicznych SALUS — Wroclaw, 52-210, Poland — Recruiting
Hospital Universitario Vall d'Hebron — Barcelona, 08035, Spain — Recruiting
Hospital Clinico Universitario de Valladolid — Valladolid, 47003, Spain — Recruiting
Perseverance Research Center, LLC — Scottsdale, Arizona, 85253, United States — Recruiting
Advanced Research Center, Inc. — Anaheim, California, 92805, United States — Recruiting
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
The Neurology Group — Pomona, California, 91767, United States — Recruiting
Sunwise Clinical Research — Walnut Creek, California, 94596, United States — Recruiting
Children's Hospital Colorado — Aurora, Colorado, 80045, United States — Recruiting
Children's Hospital Colorado- Investigational Drug Services — Aurora, Colorado, 80045, United States — Recruiting
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
South Florida Research Phase I-IV, Inc — Miami, Florida, 33166, United States — Recruiting
Clinical Associates of Orlando, LLC — Orlando, Florida, 32819, United States — Recruiting
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

Study details

Start date: April 28, 2021
Primary completion date: July 31, 2030
Completion date: July 31, 2030
First posted: February 8, 2021

Source and update information

Source: ClinicalTrials.gov
NCT ID: NCT04743141
Registry last updated: September 24, 2026
QualifiedStudies registry data refreshed: October 5, 2026
QualifiedStudies record fetched: October 5, 2026

View NCT04743141 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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