Long-term Safety Study of Rimegepant in Pediatric Subjects for the Acute Treatment of Migraine
Launched by PFIZER · Feb 5, 2021
Trial Information
Current as of July 26, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying the long-term safety of a medication called rimegepant for treating migraines in children and teenagers aged 6 to 17 years old. The goal is to see how well rimegepant works for kids who experience moderate to severe migraine attacks. To participate, children need to have a history of migraines for at least six months and have had between one to eight migraine days each month in the two months before joining the study. They should weigh at least 40 kilograms and be able to tell the difference between migraines and other headaches.
Participants in the trial can expect to receive the medication and be monitored by healthcare professionals to ensure their safety over the study period. It's important to note that certain conditions, like a history of cluster headaches or serious psychiatric issues, may prevent someone from joining. The trial is currently looking for participants, and it offers an opportunity to help improve migraine treatment for children in the future.
Gender
ALL
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 Pfizer
Pfizer Inc. is a global leader in biopharmaceutical innovation, dedicated to discovering, developing, and delivering advanced therapies that enhance patient outcomes across a wide range of medical conditions. With a rich history of scientific research and a commitment to quality, Pfizer focuses on areas such as oncology, immunology, cardiology, and rare diseases. The company leverages cutting-edge technology and collaborates with healthcare professionals, regulatory bodies, and academic institutions to conduct rigorous clinical trials that ensure the safety and efficacy of its products. Pfizer's mission is to bring breakthroughs that change patients' lives, exemplifying its commitment to health and wellness worldwide.
Contacts
Jennifer Cobb
Immunology at National Institute of Allergy and Infectious Diseases (NIAID)
Locations
Lexington, Kentucky, United States
New York, New York, United States
Philadelphia, Pennsylvania, United States
New Orleans, Louisiana, United States
Norfolk, Virginia, United States
Portland, Oregon, United States
Portland, Oregon, United States
Cincinnati, Ohio, United States
Santander, , Spain
Hartford, Connecticut, United States
Aurora, Colorado, United States
Seattle, Washington, United States
Los Angeles, California, United States
Salt Lake City, Utah, United States
Cincinnati, Ohio, United States
Richmond, Virginia, United States
Madison, Wisconsin, United States
Gainesville, Florida, United States
Richmond, Virginia, United States
Sacramento, California, United States
Santander, , Spain
Santander, Cantabria, Spain
San Diego, California, United States
Sevilla, , Spain
Lexington, Kentucky, United States
Rochester, New York, United States
Ann Arbor, Michigan, United States
Atlanta, Georgia, United States
Nashville, Tennessee, United States
Fresno, California, United States
Nashville, Tennessee, United States
Amherst, New York, United States
Barcelona, , Spain
Memphis, Tennessee, United States
Barcelona, , Spain
Madison, Wisconsin, United States
Hartford, Connecticut, United States
Madrid, , Spain
Aurora, Colorado, United States
Cleveland, Ohio, United States
Indianapolis, Indiana, United States
Austin, Texas, United States
Bellevue, Washington, United States
Greensboro, North Carolina, United States
New York, New York, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Atlanta, Georgia, United States
Boston, Massachusetts, United States
Memphis, Tennessee, United States
Colorado Springs, Colorado, United States
Barcelona, , Spain
Katowice, , Poland
New York, New York, United States
West Palm Beach, Florida, United States
Fresno, California, United States
Decatur, Georgia, United States
Tempe, Arizona, United States
Culver City, California, United States
Plano, Texas, United States
Springfield, Missouri, United States
Lincoln, Nebraska, United States
Oklahoma City, Oklahoma, United States
Scottsdale, Arizona, United States
Wrocław, , Poland
Long Beach, California, United States
Kraków, , Poland
Lincoln, Nebraska, United States
Anaheim, California, United States
Cromwell, Connecticut, United States
Plano, Texas, United States
Scottsdale, Arizona, United States
Tampa, Florida, United States
Greensboro, North Carolina, United States
Winston Salem, North Carolina, United States
Everett, Washington, United States
Wroclaw, , Poland
Bellaire, Texas, United States
Valladolid, , Spain
Lake City, Florida, United States
East Greenwich, Rhode Island, United States
North Charleston, South Carolina, United States
Pomona, California, United States
Oklahoma City, Oklahoma, United States
Salt Lake City, Utah, United States
Miami, Florida, United States
Krakow, , Poland
Waltham, Massachusetts, United States
Stamford, Connecticut, United States
Stamford, Connecticut, United States
Springfield, Missouri, United States
Missoula, Montana, United States
Waltham, Massachusetts, United States
Frisco, Texas, United States
East Greenwich, Rhode Island, United States
Port Jefferson Station, New York, United States
Atlanta, Georgia, United States
Greer, South Carolina, United States
Bellaire, Texas, United States
Krakow, , Poland
Great Falls, Montana, United States
New York, New York, United States
Upland, California, United States
La Jolla, California, United States
Lafayette, California, United States
Helena, Montana, United States
Miami, Florida, United States
Ozark, Missouri, United States
Clarksville, Tennessee, United States
Orlando, Florida, United States
Dallas, Texas, United States
Cincinnati, Ohio, United States
Banning, California, United States
Los Angeles, California, United States
North Hollywood, California, United States
Upland, California, United States
Grand Junction, Colorado, United States
Lake City, Florida, United States
Naples, Florida, United States
Orange Park, Florida, United States
South Miami, Florida, United States
Brunswick, Georgia, United States
Indianapolis, Indiana, United States
Noblesville, Indiana, United States
Des Moines, Iowa, United States
Overland Park, Kansas, United States
Waltham, Massachusetts, United States
Ann Arbor, Michigan, United States
Kalamazoo, Michigan, United States
Royal Oak, Michigan, United States
Great Falls, Montana, United States
Helena, Montana, United States
Kalispell, Montana, United States
Missoula, Montana, United States
Charlotte, North Carolina, United States
Cincinnati, Ohio, United States
Columbus, Ohio, United States
Grants Pass, Oregon, United States
Greenville, South Carolina, United States
Greenville, South Carolina, United States
Austin, Texas, United States
Austin, Texas, United States
Frisco, Texas, United States
Houston, Texas, United States
Szczecin, , Poland
Seville, , Spain
Chula Vista, California, United States
Miami Springs, Florida, United States
Port Jefferson Station, New York, United States
Cincinnati, Ohio, United States
Dayton, Ohio, United States
Grants Pass, Oregon, United States
Philadelphia, Pennsylvania, United States
Houston, Texas, United States
Katowice, , Poland
Wrocław, , Poland
Valladolid, , Spain
Miami, Florida, United States
Everett, Washington, United States
Atlanta, Georgia, United States
El Paso, Texas, United States
New York, New York, United States
Chicago, Illinois, United States
Houston, Texas, United States
Washington, District Of Columbia, United States
Houston, Texas, United States
Barcelona, , Spain
Orlando, Florida, United States
Poznań, Wielkopolska, Poland
Decatur, Georgia, United States
Noblesville, Indiana, United States
Los Angeles, California, United States
Miami, Florida, United States
Brunswick, Georgia, United States
Indianapolis, Indiana, United States
Great Falls, Montana, United States
New York, New York, United States
New York, New York, United States
Austin, Texas, United States
Austin, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
Salt Lake City, Utah, United States
Los Angeles, California, United States
Aurora, Colorado, United States
Aurora, Colorado, United States
Grand Junction, Colorado, United States
Grand Junction, Colorado, United States
Atlanta, Georgia, United States
Overland Park, Kansas, United States
Royal Oak, Michigan, United States
Kalispell, Montana, United States
New York, New York, United States
Cincinnati, Ohio, United States
Greenville, South Carolina, United States
Houston, Texas, United States
Houston, Texas, United States
Norfolk, Virginia, United States
Karkow, , Poland
Krakow, , Poland
Long Beach, California, United States
Banning, California, United States
Memphis, Tennessee, United States
Memphis, Tennessee, United States
Katowice, , Poland
Poznań, , Poland
Szczecin,, , Poland
Wroclaw, , Poland
Sevilla, , Spain
Grand Rapids, Michigan, United States
Seattle, Washington, United States
Orlando, Florida, United States
Westfield, Indiana, United States
Sacramento, California, United States
Sacramento, California, United States
Sacramento, California, United States
Portland, Oregon, United States
Poznań, , Poland
Balenya, Barcelona, Spain
Portland, Oregon, United States
Chicago, Illinois, United States
Neptune, New Jersey, United States
Scottsdale, Arizona, United States
Grand Rapids, Michigan, United States
Grand Rapids, Michigan, United States
Chandler, Arizona, United States
West Des Moines, Iowa, United States
San Bernardino, California, United States
Commack, New York, United States
La Jolla, California, United States
Patients applied
Trial Officials
Pfizer CT.gov Call Center
Study Director
Pfizer
Timeline
First submit
Trial launched
Trial updated
Estimated completion
Not reported
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