Home › Migraine › NCT04743141
Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
RecruitingPhase 3
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
Who can join
Ages 6 to 17 · All sexes
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.
About the study
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).
What is being tested
- Rimegepant (PF-07899801) (drug)
Sponsor: Pfizer · Participants: 600 · Started: Apr 28, 2021
Contact the study team
Official record on ClinicalTrials.gov — NCT04743141
Locations in the U.S.
| Arizona | Perseverance Research Center, LLC, Scottsdale |
| California | Advanced Research Center, Inc., Anaheim Neuro-Pain Research Center, Fresno Altman Clinical and Translational Research Institute, University of California San Diego, La Jolla Adult & Child Neurology Medical Associates, Long Beach Memorialcare Miller Children's & Women's Hospital Long Beach, Long Beach The Neurology Group, Pomona Sunwise Clinical Research, Walnut Creek |
| Colorado | Children's Hospital Colorado, Aurora Children's Hospital Colorado- Investigational Drug Services, Aurora |
| Connecticut | CT Clinical Research, Cromwell Ki Health Partners, LLc, dba New England Institute for Clinical Research, Stamford |
| District of Columbia | Children's National Medical Center, Washington D.C. |
| Florida | South Florida Research Phase I-IV, Inc, Miami Clinical Associates of Orlando, LLC, Orlando |
| Georgia | CenExel iResearch, LLC, Decatur |
| Illinois | Chicago Headache Center & Research Institute, Chicago AMR-Baber Research Inc, Naperville |
| Indiana | Options Research Group, LLC, Westfield |
| Iowa | Integrated Clinical Trial Services, Inc., West Des Moines |
| Kansas | Clinical Associates Midwest, LLC, Kansas City |
| Michigan | Michigan Head Pain and Neurological Institute, Ann Arbor Corewell Health, Helen DeVos Children's Hospital, Grand Rapids Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group, Grand Rapids Beaumont Hospital, Royal Oak Campus, Royal Oak |
| Nebraska | Children's Hospital & Medical Center, Omaha |
| New Jersey | HMH Jersey Shore University Medical Center, Neptune City Hope Tower, Neptune City |
| New York | Dent Neurosciences Research Center, Amherst True North Neurology, Commack New York Neurology Associates, New York |
| North Carolina | OnSite Clinical Solutions, LLC, Charlotte |
| Ohio | Cincinnati Children's Hospital, Cincinnati University Hospitals Cleveland Medical Center, Cleveland |
| Oregon | Providence Neuroscience Institute: Research Coordinators' Office, Portland Providence Pediatric Specialty Clinic, Portland |
| Rhode Island | Velocity Clinical Research-Providence, East Greenwich |
| Texas | Child Neurology Consultants of Austin - Central Austin, Austin Dell Children's Medical Center, Austin Houston Clinical Trials, LLC, Bellaire ANESC Research, El Paso NeuroCare Plus, Houston Pain and Headache Centers of Texas, Houston SCLA Management, Houston |
| Utah | JBR Clinical Research, Salt Lake City Wasatch Clinical Research , LLC(Administrative Location), Salt Lake City |
| Virginia | Pediatric Associates of Charlottesville, PLC (Private Pediatric Practice), Charlottesville Pediatric Research of Charlottesville, LLC, Charlottesville Pediatric Research of Charlottesville, LLC (Regulatory Only), Charlottesville CHKD Health Center, Norfolk Children's Hospital of The King's Daughters, Norfolk |
| Washington | Northwest Clinical Research Center, Bellevue Seattle Children's Hospital, Seattle Seattle Children's Hospital Investigational Drug Services, Seattle |
| Wisconsin | University Hospital, Madison |
Conditions
From ClinicalTrials.gov, data retrieved Nov 15, 2026. Each study sets its own eligibility; the study team decides who can join.