NCT04743141From ClinicalTrials.govRecruiting

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

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

Acute Treatment of Migraine

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Pfizer
Enrolment target: 600
Started: 28 April 2021
Main results due: 31 July 2030
Study sites: 124
Registry updated: 24 September 2026

Can you take part?

Ages 6 years to 17 years.
Open to any sex.
You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full 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.

What this study is about

In the sponsor’s own words, from the registry.

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).

Study sites(124)

Perseverance Research Center, LLC
Scottsdale, Arizona, United States
Recruiting
Physicians Research Group
Tempe, Arizona, United States
Active, not recruiting
Advanced Research Center, Inc.
Anaheim, California, United States
Recruiting
ProScience Research Group
Culver City, California, United States
Active, not recruiting
Neuro-Pain Research Center
Fresno, California, United States
Recruiting
Altman Clinical and Translational Research Institute, University of California San Diego
La Jolla, California, United States
Recruiting
Adult & Child Neurology Medical Associates
Long Beach, California, United States
Recruiting
Memorialcare Miller Children's & Women's Hospital Long Beach
Long Beach, California, United States
Recruiting
Velocity Clinical Research - North Hollywood
North Hollywood, California, United States
Active, not recruiting
The Neurology Group
Pomona, California, United States
Recruiting
UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
Sacramento, California, United States
Active, not recruiting
University of California, Davis Clinical and Translational Science Center Clinical Research Center
Sacramento, California, United States
Active, not recruiting
University of California, Davis Midtown Clinic
Sacramento, California, United States
Active, not recruiting
Velocity Clinical Research- Banning
San Bernardino, California, United States
Active, not recruiting
Pacific Clinical Research Management Group LLC
Upland, California, United States
Active, not recruiting
Sunwise Clinical Research
Walnut Creek, California, United States
Recruiting
Children's Hospital Colorado- Investigational Drug Services
Aurora, Colorado, United States
Recruiting
Children's Hospital Colorado
Aurora, Colorado, United States
Recruiting
Colorado Springs Neurological Associates, PC
Colorado Springs, Colorado, United States
Active, not recruiting
Colorado Springs Neurological Associates, PC
Colorado Springs, Colorado, United States
Active, not recruiting
Boeson Research GJT
Grand Junction, Colorado, United States
Terminated
Dinosaur Pediatrics
Grand Junction, Colorado, United States
Terminated
Boeson Research GJT
Grand Junction, Colorado, United States
Terminated
CT Clinical Research
Cromwell, Connecticut, United States
Recruiting
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, United States
Recruiting
Children's National Medical Center
Washington D.C., District of Columbia, United States
Recruiting
AppleMed Research Group, LLC
Miami, Florida, United States
Active, not recruiting
Medical Research Center of Miami II, Inc
Miami, Florida, United States
Active, not recruiting
South Florida Research Phase I-IV, Inc
Miami, Florida, United States
Recruiting
Physicians Group Services, PA d/b/a Coastal Health Research
Orange Park, Florida, United States
Active, not recruiting
Clinical Associates of Orlando, LLC
Orlando, Florida, United States
Recruiting
ForCare Clinical Research
Tampa, Florida, United States
Active, not recruiting
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
Active, not recruiting
Rare Disease Research LLC
Atlanta, Georgia, United States
Active, not recruiting
Pivotal Clinical Research & Associates, LLC
Brunswick, Georgia, United States
Active, not recruiting
CenExel iResearch, LLC
Decatur, Georgia, United States
Recruiting
Chicago Headache Center & Research Institute
Chicago, Illinois, United States
Recruiting
AMR-Baber Research Inc
Naperville, Illinois, United States
Recruiting
Options Research Group, LLC
Westfield, Indiana, United States
Recruiting
Integrated Clinical Trial Services, Inc.
West Des Moines, Iowa, United States
Recruiting
Clinical Associates Midwest, LLC
Kansas City, Kansas, United States
Recruiting
University of Kentucky Hospital
Lexington, Kentucky, United States
Active, not recruiting
Ochsner Clinic Foundation
New Orleans, Louisiana, United States
Terminated
MedVadis Research Corporation
Waltham, Massachusetts, United States
Active, not recruiting
Michigan Head Pain and Neurological Institute
Ann Arbor, Michigan, United States
Recruiting
Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group
Grand Rapids, Michigan, United States
Recruiting
Corewell Health, Helen DeVos Children's Hospital
Grand Rapids, Michigan, United States
Recruiting
Wellnow Urgent Care and Research
Kalamazoo, Michigan, United States
Terminated
Beaumont Hospital, Royal Oak Campus
Royal Oak, Michigan, United States
Recruiting
Sharlin Health Neuroscience Research Center
Ozark, Missouri, United States
Active, not recruiting
Clinvest Research, LLC
Springfield, Missouri, United States
Active, not recruiting
Boeson Research
Great Falls, Montana, United States
Active, not recruiting
Heart & Hands Midwifery
Kalispell, Montana, United States
Active, not recruiting
Blue Moose Pediatrics
Missoula, Montana, United States
Active, not recruiting
Boeson Research Laboratory
Missoula, Montana, United States
Active, not recruiting
Boeson Research
Missoula, Montana, United States
Active, not recruiting
Alivation Research, LLC
Lincoln, Nebraska, United States
Terminated
Children's Hospital & Medical Center
Omaha, Nebraska, United States
Recruiting
HMH Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Recruiting
Hope Tower
Neptune City, New Jersey, United States
Recruiting

Showing 60 of 124 sites — filter to narrow it down. 61 of the 124 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT04743141. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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