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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

Sponsor: Pfizer · Participants: 600 · Started: Apr 28, 2021

Contact the study team

Official record on ClinicalTrials.gov — NCT04743141

Locations in the U.S.

ArizonaPerseverance Research Center, LLC, Scottsdale
CaliforniaAdvanced 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
ColoradoChildren's Hospital Colorado, Aurora
Children's Hospital Colorado- Investigational Drug Services, Aurora
ConnecticutCT Clinical Research, Cromwell
Ki Health Partners, LLc, dba New England Institute for Clinical Research, Stamford
District of ColumbiaChildren's National Medical Center, Washington D.C.
FloridaSouth Florida Research Phase I-IV, Inc, Miami
Clinical Associates of Orlando, LLC, Orlando
GeorgiaCenExel iResearch, LLC, Decatur
IllinoisChicago Headache Center & Research Institute, Chicago
AMR-Baber Research Inc, Naperville
IndianaOptions Research Group, LLC, Westfield
IowaIntegrated Clinical Trial Services, Inc., West Des Moines
KansasClinical Associates Midwest, LLC, Kansas City
MichiganMichigan 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
NebraskaChildren's Hospital & Medical Center, Omaha
New JerseyHMH Jersey Shore University Medical Center, Neptune City
Hope Tower, Neptune City
New YorkDent Neurosciences Research Center, Amherst
True North Neurology, Commack
New York Neurology Associates, New York
North CarolinaOnSite Clinical Solutions, LLC, Charlotte
OhioCincinnati Children's Hospital, Cincinnati
University Hospitals Cleveland Medical Center, Cleveland
OregonProvidence Neuroscience Institute: Research Coordinators' Office, Portland
Providence Pediatric Specialty Clinic, Portland
Rhode IslandVelocity Clinical Research-Providence, East Greenwich
TexasChild 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
UtahJBR Clinical Research, Salt Lake City
Wasatch Clinical Research , LLC(Administrative Location), Salt Lake City
VirginiaPediatric 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
WashingtonNorthwest Clinical Research Center, Bellevue
Seattle Children's Hospital, Seattle
Seattle Children's Hospital Investigational Drug Services, Seattle
WisconsinUniversity Hospital, Madison

Conditions

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.