Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
Launched by PFIZER · Nov 30, 2021
Trial Information
Current as of July 27, 2025
Recruiting
Keywords
ClinConnect Summary
This clinical trial is studying a medication called rimegepant to see if it can help prevent migraines in children and teenagers aged 6 to under 18 years. Researchers want to find out if rimegepant is more effective than a placebo (which is an inactive treatment) for young people who experience episodic migraines. To be eligible for the study, participants must have experienced migraines for at least six months, have a certain number of headache days per month, and show some impact on their daily activities due to migraines.
If your child qualifies and decides to participate, they will be closely monitored throughout the trial. This includes regular visits where their migraines and any side effects will be recorded. It's important to know that participants should not have certain types of migraines or other significant health issues that could interfere with the study. The goal is to gather information that could help improve migraine treatment for kids and teens in the future.
Gender
ALL
Eligibility criteria
- Inclusion Criteria:
- 1. Subject has at least a 6 month history of migraine (with or without aura) and including the following:
- • 1. 14 or less headache days per month during the 3 month period prior to the Screening Visit
- • 2. 6 or more migraine days during the Observation Period
- • 3. 14 or less headache days during the Observation Period
- • 4. Pediatric Migraine Disability Assessment Scale (PedMIDAS) Disability Score of \>10 to ≤50, indicating mild (score of 11 to 30) or moderate (score of 31 to 50) disruption in daily activities, as assessed at the Baseline (Randomization) Visit
- • 5. Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
- • 6. Migraine attacks, on average, lasting 4 - 72 hours if untreated
- • 7. Subjects on prophylactic migraine medication are permitted to remain on therapy if the dose has been stable for at least 3 months (12 weeks) prior to the Screening Phase, and the dose is not expected to change during the course of the study. 2) Male and female subjects ≥ 6 to \<18 years; subjects must be less than 18 at the time of signing assent / consent.
- • 3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.
- Exclusion Criteria:
- • 1. Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
- • 2. The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
- • 3. The subject has a history or diagnosis of complications of migraine
- • 4. The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
- • 5. The subject has any current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Subjects with a lifetime history of psychosis and/or mania are excluded.
- • 6. History of suicidal behavior or the subject is at risk of self-harm or harm to others.
- • 7. History of major psychiatric disorder.
- • 8. The subject has a current diagnosis or history of substance abuse
- • 9. The subject has a history of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is, in the investigator's opinion, likely to affect central nervous system functioning.
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
Bronx, New York, United States
Ottawa, Ontario, Canada
Columbia, Missouri, United States
Brescia, , Italy
Palo Alto, California, United States
Cincinnati, Ohio, United States
Bronx, New York, United States
Rochester, New York, United States
Oklahoma City, Oklahoma, United States
Reno, Nevada, United States
Vancouver, British Columbia, Canada
Sevilla, , Spain
Fort Collins, Colorado, United States
Augusta, Georgia, United States
Shinjuku Ku, Tokyo, Japan
Columbus, Ohio, United States
Valencia, , Spain
Boise, Idaho, United States
Toulouse, , France
Minot, North Dakota, United States
Lincoln, Nebraska, United States
Madrid, , Spain
Roma, Lazio, Italy
Santiago De Compostela, La Coruna, Spain
Nashville, Tennessee, United States
Albuquerque, New Mexico, United States
Amherst, New York, United States
Warszawa, , Poland
Colorado Springs, Colorado, United States
Loxahatchee Groves, Florida, United States
Krakow, , Poland
Boise, Idaho, United States
Créteil, , France
Shinjyuku Ku, Tokyo, Japan
Valencia, , Spain
Milano, , Italy
Chicago, Illinois, United States
San Antonio, Texas, United States
Florence, , Italy
Savannah, Georgia, United States
Savannah, Georgia, United States
Orlando, Florida, United States
Sabadell, Barcelona, Spain
Sherman, Texas, United States
Montpellier, , France
Charleston, South Carolina, United States
Lincoln, Nebraska, United States
Sandy Springs, Georgia, United States
Sioux Falls, South Dakota, United States
Hialeah, Florida, United States
Lublin, , Poland
Sioux Falls, South Dakota, United States
Lake Jackson, Texas, United States
Vigo, , Spain
Lampasas, Texas, United States
Valladolid, , Spain
Kansas City, Missouri, United States
Lake Jackson, Texas, United States
Hastings, Nebraska, United States
Shibuya Ku, Tokyo, Japan
Walnut Creek, California, United States
Colorado Springs, Colorado, United States
Vigo, Galicia, Spain
Frisco, Texas, United States
Cincinnati, Ohio, United States
Hawthorne, California, United States
Tampa, Florida, United States
Ormond Beach, Florida, United States
Tampa, Florida, United States
Mcallen, Texas, United States
Bradenton, Florida, United States
Miami, Florida, United States
Charleston, South Carolina, United States
Greenville, South Carolina, United States
Ajax, Ontario, Canada
Columbia, Missouri, United States
Greenville, South Carolina, United States
Edgewater, Florida, United States
Washington, District Of Columbia, United States
Toms River, New Jersey, United States
South Ogden, Utah, United States
La Mesa, California, United States
Créteil, , France
Fort Smith, Arkansas, United States
Hawthorne, California, United States
Clermont, Florida, United States
Hollywood, Florida, United States
Miami, Florida, United States
Tamarac, Florida, United States
Snellville, Georgia, United States
New Orleans, Louisiana, United States
Columbia, Missouri, United States
Hastings, Nebraska, United States
Toms River, New Jersey, United States
Albuquerque, New Mexico, United States
Bronx, New York, United States
Cincinnati, Ohio, United States
Cincinnati, Ohio, United States
Charleston, South Carolina, United States
Sioux Falls, South Dakota, United States
Arlington, Texas, United States
Houston, Texas, United States
Houston, Texas, United States
San Antonio, Texas, United States
Victoria, Texas, United States
Portsmouth, Virginia, United States
Mito Shi, Ibaraki, Japan
Portsmouth, Virginia, United States
Matsuyama Shi, Ehime, Japan
Kasuga Shi, Fukuoka, Japan
Kagoshima Shi, Kagoshima, Japan
Pasadena, California, United States
Tamarac, Florida, United States
Sherman, Texas, United States
Papillion, Nebraska, United States
New Haven, Connecticut, United States
Natchez, Mississippi, United States
Papillion, Nebraska, United States
Clinton, Missouri, United States
Fayetteville, North Carolina, United States
Santiago De Compostela, , Spain
Toulouse, , France
Barcelona, , Spain
Houston, Texas, United States
Houston, Texas, United States
Fort Smith, Arkansas, United States
La Mesa, California, United States
Dallas, Texas, United States
Houston, Texas, United States
Mcallen, Texas, United States
Tomball, Texas, United States
Valladolid, Castilla Y Leon, Spain
Sevilla, , Spain
Kochi Shi, Kōchi, Japan
Naniwa Ku, Osaka Shi, Osaka, Japan
Sioux Falls, South Dakota, United States
Wroclaw, Dolnoslaskie, Poland
Snellville, Georgia, United States
Columbia, Missouri, United States
Columbia, Missouri, United States
Columbia, Missouri, United States
Fayetteville, North Carolina, United States
Avellino, Avellino/Campania, Italy
Latina, Latina/Lazio, Italy
Lublin, Lubelskie, Poland
Katowice, Slaskie, Poland
Brescia, Lombardy, Italy
Poznan, Wielkopolskie, Poland
Clinton, Mississippi, United States
South Ogden, Utah, United States
Pavia, Padua, Italy
Rome, , Italy
Montpellier, , France
Firenze, Florence, Italy
Latina, Latina/Lazio, Italy
Pavia, Pavia/Lombardy, Italy
Bari, , Italy
Lublin, Lubelskie, Poland
Krakow, Malopolskie, Poland
Brescia, Brescia/Lombardy, Italy
Florence, Florence/Tuscany, Italy
Warszawa, Mazowieckie, Poland
Bari, Bari / Puglia, Italy
Rome, Rome / Latium, Italy
Poznan, Wielkopolskie, Poland
Dallas, Texas, United States
Warszawa, Mazowieckie, Poland
Edgewater, Florida, United States
Nishinomiya Shi, Hyōgo, Japan
Ajax, Ontario, Canada
Milan, Milan/Lombardy, Italy
Higashinada Ku Kobe Shi, Hyōgo, Japan
Taihaku Ku Sendai Shi, Miyagi, Japan
Roma, , Italy
Naka Ku Hiroshima Shi, Hiroshima, Japan
Rome, Rome/Lazio, Italy
Kiryu Shi, Gunma, Japan
Abeno Ku Osaka Shi, Osaka, Japan
Katowice, Slaskie, Poland
Chuo Ku Saitama Shi, Saitama, Japan
Hiroshima, , Japan
Hastings, Nebraska, United States
Houston, Texas, United States
Houston, Texas, United States
Milano, Lombardia, Italy
Columbia, Missouri, United States
Grand Island, Nebraska, United States
Warsaw, Woj. Mazowieckie, Poland
Bradenton, Florida, United States
Dallas, Texas, United States
Naniwa Ku, Osaka, Japan
Roma, Lazio, Italy
Kagoshima City, Kagoshima, Japan
Grand Island, Nebraska, United States
Pavia, Lombardia, Italy
Higashinada Ku Kobe Shi, , Japan
Avellino, , Italy
Bari, , Italy
Latina, , Italy
Nishinomiya Shi, , Japan
Kochi Shi, , Japan
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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