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Clinical Trials in the USA / NCT04743141
Recruiting Phase 3

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

NCT04743141 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2021-04-28
Last updated
2026-08-14

Condition(s) studied

Acute Treatment of Migraine

Investigational drug(s) / intervention(s)

Rimegepant (PF-07899801)

Rimegepant (PF-07899801): Rimegepant 75 mg, 50 mg or 35 mg ODT

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).

Eligibility

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (124)

FacilityCityRegionStatus
Perseverance Research Center, LLC Scottsdale Arizona Recruiting
Physicians Research Group Tempe Arizona Active Not Recruiting
Advanced Research Center, Inc. Anaheim California Recruiting
ProScience Research Group Culver City California Active Not Recruiting
Neuro-Pain Research Center Fresno California Recruiting
Altman Clinical and Translational Research Institute, University of California San Diego La Jolla California Recruiting
Adult & Child Neurology Medical Associates Long Beach California Recruiting
Memorialcare Miller Children's & Women's Hospital Long Beach Long Beach California Recruiting
Velocity Clinical Research - North Hollywood North Hollywood California Active Not Recruiting
The Neurology Group Pomona California Recruiting
UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy Sacramento California Active Not Recruiting
University of California, Davis Clinical and Translational Science Center Clinical Research Center Sacramento California Active Not Recruiting
University of California, Davis Midtown Clinic Sacramento California Active Not Recruiting
Velocity Clinical Research- Banning San Bernardino California Recruiting
Pacific Clinical Research Management Group LLC Upland California Active Not Recruiting
Sunwise Clinical Research Walnut Creek California Recruiting
Children's Hospital Colorado- Investigational Drug Services Aurora Colorado Recruiting
Children's Hospital Colorado Aurora Colorado Recruiting
Colorado Springs Neurological Associates, PC Colorado Springs Colorado Active Not Recruiting
Colorado Springs Neurological Associates, PC Colorado Springs Colorado Active Not Recruiting
Boeson Research GJT Grand Junction Colorado Terminated
Dinosaur Pediatrics Grand Junction Colorado Terminated
Boeson Research GJT Grand Junction Colorado Terminated
CT Clinical Research Cromwell Connecticut Recruiting
Ki Health Partners, LLc, dba New England Institute for Clinical Research Stamford Connecticut Recruiting
Children's National Medical Center Washington D.C. District of Columbia Recruiting
AppleMed Research Group, LLC Miami Florida Active Not Recruiting
Medical Research Center of Miami II, Inc Miami Florida Active Not Recruiting
South Florida Research Phase I-IV, Inc Miami Florida Recruiting
Physicians Group Services, PA d/b/a Coastal Health Research Orange Park Florida Active Not Recruiting
Clinical Associates of Orlando, LLC Orlando Florida Recruiting
ForCare Clinical Research Tampa Florida Active Not Recruiting
Premiere Research Institute at Palm Beach Neurology West Palm Beach Florida Active Not Recruiting
Rare Disease Research LLC Atlanta Georgia Active Not Recruiting
Pivotal Clinical Research & Associates, LLC Brunswick Georgia Recruiting
CenExel iResearch, LLC Decatur Georgia Recruiting
Chicago Headache Center & Research Institute Chicago Illinois Recruiting
AMR-Baber Research Inc Naperville Illinois Recruiting
Options Research Group, LLC Westfield Indiana Recruiting
Integrated Clinical Trial Services, Inc. West Des Moines Iowa Recruiting

+ 84 more sites — see the full list on the official registry below.

More Pfizer trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT04743141 on ClinicalTrials.gov ↗ ← All trials in the USA