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

Recruiting now · Phase 3

Conditions studied: Acute Treatment of Migraine

In brief

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).

Key facts

Study ID

NCT04743141

Run by

Pfizer

People needed

600

Starts

2021-04-28

Expected to finish

2030-07-31

Last updated by the study team

2026-07-30

Who can join

Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• History of migraine (with or without aura) for ≥ 6 months before Screening.
• History of 1 to 8 moderate or severe attacks per month during the 2 months prior to screening.
• 1 or more migraine days requiring treatment during the Observation Phase.
• Prophylactic migraine medication is permitted if the dose has been stable for at least 12 weeks prior to the Screening Visit.
• Ability to distinguish between migraine and other types of headaches.
• Weight > 15 kg. For EU countries only: Participants 12 to < 18 years of age must have a body weight of >25kg.
• Adequate venous access for blood sampling.
• Male and female participants 6 to < 18 years of age (participants must not reach their 18th birthday on or before the Baseline visit).

You may not qualify if…

• History of cluster headache or hemiplegic migraine headache.
• Confounding and clinically significant pain syndrome.
• 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).
• History of suicidal behavior or at risk of self-harm/harm to others.
• History of major psychiatric disorder.
• Current diagnosis or history of substance abuse
• Reported current use of or tested positive at Screening for drugs of abuse.

Where it is running

• Options Research Group, LLC — Westfield, Indiana, United States (enrolling)
• Michigan Head Pain and Neurological Institute — Ann Arbor, Michigan, United States (enrolling)
• South Florida Research Phase I-IV, Inc — Miami, Florida, United States (enrolling)
• AMR-Baber Research Inc — Naperville, Illinois, United States (enrolling)
• Integrated Clinical Trial Services, Inc. — West Des Moines, Iowa, United States (enrolling)
• Clinical Associates Midwest, LLC — Kansas City, Kansas, United States (enrolling)
• Memorialcare Miller Children's & Women's Hospital Long Beach — Long Beach, California, United States (enrolling)
• Children's National Medical Center — Washington D.C., District of Columbia, United States (enrolling)
• Pivotal Clinical Research & Associates, LLC — Brunswick, Georgia, United States (enrolling)
• Chicago Headache Center & Research Institute — Chicago, Illinois, United States (enrolling)
• Altman Clinical and Translational Research Institute, University of California San Diego — La Jolla, California, United States (enrolling)
• Advanced Research Center, Inc. — Anaheim, California, United States (enrolling)
• Velocity Clinical Research- Banning — San Bernardino, California, United States (enrolling)
• Adult & Child Neurology Medical Associates — Long Beach, California, United States (enrolling)
• Sunwise Clinical Research — Walnut Creek, California, United States (enrolling)
• Children's Hospital Colorado- Investigational Drug Services — Aurora, Colorado, United States (enrolling)
• Children's Hospital Colorado — Aurora, Colorado, United States (enrolling)
• Perseverance Research Center, LLC — Scottsdale, Arizona, United States (enrolling)
• The Neurology Group — Pomona, California, United States (enrolling)
• Clinical Associates of Orlando, LLC — Orlando, Florida, United States (enrolling)
• Neuro-Pain Research Center — Fresno, California, United States (enrolling)
• CenExel iResearch, LLC — Decatur, Georgia, United States (enrolling)
• CT Clinical Research — Cromwell, Connecticut, United States (enrolling)
• Ki Health Partners, LLc, dba New England Institute for Clinical Research — Stamford, Connecticut, United States (enrolling)
• Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group — Grand Rapids, Michigan, United States (enrolling)

Full record on ClinicalTrials.gov

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