Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Recruiting · NCT04743141 · Interventional (participants receive a specific treatment) · Lead sponsor: Pfizer
View the official record on ClinicalTrials.gov →Interventions studied
Rimegepant (PF-07899801)
What this trial is about
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).
Who can take part
Age range
6 Years to 17 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- 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).
Exclusion criteria
- 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
60 locations listed across 33 US states.
- Perseverance Research Center, LLC - Scottsdale, Arizona, United States
- Physicians Research Group - Tempe, Arizona, United States
- Advanced Research Center, Inc. - Anaheim, California, United States
- ProScience Research Group - Culver City, California, United States
- Neuro-Pain Research Center - Fresno, California, United States
- Altman Clinical and Translational Research Institute, University of California San Diego - La Jolla, California, United States
- Adult & Child Neurology Medical Associates - Long Beach, California, United States
- Memorialcare Miller Children's & Women's Hospital Long Beach - Long Beach, California, United States
- Velocity Clinical Research - North Hollywood - North Hollywood, California, United States
- The Neurology Group - Pomona, California, United States
- UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy - Sacramento, California, United States
- University of California, Davis Clinical and Translational Science Center Clinical Research Center - Sacramento, California, United States
- University of California, Davis Midtown Clinic - Sacramento, California, United States
- Velocity Clinical Research- Banning - San Bernardino, California, United States
- Pacific Clinical Research Management Group LLC - Upland, California, United States
- Sunwise Clinical Research - Walnut Creek, California, United States
- Children's Hospital Colorado- Investigational Drug Services - Aurora, Colorado, United States
- Children's Hospital Colorado - Aurora, Colorado, United States
- Colorado Springs Neurological Associates, PC - Colorado Springs, Colorado, United States
- Colorado Springs Neurological Associates, PC - Colorado Springs, Colorado, United States
- Boeson Research GJT - Grand Junction, Colorado, United States
- Dinosaur Pediatrics - Grand Junction, Colorado, United States
- Boeson Research GJT - Grand Junction, Colorado, United States
- CT Clinical Research - Cromwell, Connecticut, United States
- Ki Health Partners, LLc, dba New England Institute for Clinical Research - Stamford, Connecticut, United States
- Children's National Medical Center - Washington D.C., District of Columbia, United States
- AppleMed Research Group, LLC - Miami, Florida, United States
- Medical Research Center of Miami II, Inc - Miami, Florida, United States
- South Florida Research Phase I-IV, Inc - Miami, Florida, United States
- Physicians Group Services, PA d/b/a Coastal Health Research - Orange Park, Florida, United States
- Clinical Associates of Orlando, LLC - Orlando, Florida, United States
- ForCare Clinical Research - Tampa, Florida, United States
- Premiere Research Institute at Palm Beach Neurology - West Palm Beach, Florida, United States
- Rare Disease Research LLC - Atlanta, Georgia, United States
- Pivotal Clinical Research & Associates, LLC - Brunswick, Georgia, United States
- CenExel iResearch, LLC - Decatur, Georgia, United States
- Chicago Headache Center & Research Institute - Chicago, Illinois, United States
- AMR-Baber Research Inc - Naperville, Illinois, United States
- Options Research Group, LLC - Westfield, Indiana, United States
- Integrated Clinical Trial Services, Inc. - West Des Moines, Iowa, United States
- Clinical Associates Midwest, LLC - Kansas City, Kansas, United States
- University of Kentucky Hospital - Lexington, Kentucky, United States
- Ochsner Clinic Foundation - New Orleans, Louisiana, United States
- MedVadis Research Corporation - Waltham, Massachusetts, United States
- Michigan Head Pain and Neurological Institute - Ann Arbor, Michigan, United States
- Corewell Health, for and on behalf of Spectrum Health Hospital and Corewell Health Medical Group - Grand Rapids, Michigan, United States
- Corewell Health, Helen DeVos Children's Hospital - Grand Rapids, Michigan, United States
- Wellnow Urgent Care and Research - Kalamazoo, Michigan, United States
- Beaumont Hospital, Royal Oak Campus - Royal Oak, Michigan, United States
- Sharlin Health Neuroscience Research Center - Ozark, Missouri, United States
- Clinvest Research, LLC - Springfield, Missouri, United States
- Boeson Research - Great Falls, Montana, United States
- Heart & Hands Midwifery - Kalispell, Montana, United States
- Blue Moose Pediatrics - Missoula, Montana, United States
- Boeson Research Laboratory - Missoula, Montana, United States
- Boeson Research - Missoula, Montana, United States
- Alivation Research, LLC - Lincoln, Nebraska, United States
- Children's Hospital & Medical Center - Omaha, Nebraska, United States
- HMH Jersey Shore University Medical Center - Neptune City, New Jersey, United States
- Hope Tower - Neptune City, New Jersey, United States
Showing 60 of 124 listed sites. See the official record for the complete list.
Read the full protocol, contacts and eligibility on ClinicalTrials.gov →