Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Rimegepant in Migraine Prevention in Children and Adolescents ≥ 6 to <18 Years of Age
- Migraine
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Pfizer
- Enrolment target
- 640
- Started
- 28 February 2022
- Main results due
- 27 March 2029
- Study sites
- 93
- Registry updated
- 28 September 2026
Can you take part?
- Ages 6 years to 17 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full 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.What this study is about
In the sponsor’s own words, from the registry.
The purpose of this study is to compare the efficacy and safety of rimegepant to placebo as a preventative treatment for migraine in children and adolescents ≥ 6 to \<18 years with episodic migraine.
Study sites(93)
The Belinga Clinic
Fort Smith, Arkansas, United States
Active, not recruiting
Advanced Investigative Medicine, Inc.
Hawthorne, California, United States
Recruiting
Velocity Clinical Research San Diego
La Mesa, California, United States
Active, not recruiting
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Active, not recruiting
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, United States
Terminated
Velocity Clinical Research, Washington DC
Washington D.C., District of Columbia, United States
Recruiting
Accel Research Sites Network - Edgewater Clinical Research Unit
Edgewater, Florida, United States
Active, not recruiting
Direct Helpers Research Center
Hialeah, Florida, United States
Recruiting
New Med Research, Inc
Hollywood, Florida, United States
Terminated
Complete Health Research
Ormond Beach, Florida, United States
Active, not recruiting
D&H Tamarac Research Center LLC
Tamarac, Florida, United States
Recruiting
Santos Research Center, CORP
Tampa, Florida, United States
Recruiting
Clinical Trial Office
Augusta, Georgia, United States
Recruiting
Augusta University
Augusta, Georgia, United States
Recruiting
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States
Active, not recruiting
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Active, not recruiting
Extraordinary Family Healthcare
Snellville, Georgia, United States
Active, not recruiting
Renew Health Clinical Research LLC
Snellville, Georgia, United States
Active, not recruiting
Northwest Clinical Trials, Inc.
Boise, Idaho, United States
Recruiting
Diamond Headache Clinic
Chicago, Illinois, United States
Terminated
Nola Research Works, LLC
New Orleans, Louisiana, United States
Recruiting
NRST - Detroit
Detroit, Michigan, United States
Not yet recruiting
Clinical Research Institute
Minneapolis, Minnesota, United States
Not yet recruiting
Safe Haven Clinical Research
Clinton, Mississippi, United States
Terminated
Roy Blunt NextGen Precision Health Building
Columbia, Missouri, United States
Recruiting
University of Missouri Health Care - Investigation Pharmacy
Columbia, Missouri, United States
Recruiting
University of Missouri-Clinical and Translational Sciences Unit
Columbia, Missouri, United States
Recruiting
University of Missouri
Columbia, Missouri, United States
Recruiting
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, United States
Recruiting
Papillion Research Center/CCT Research
Papillion, Nebraska, United States
Recruiting
Renown Regional Medical Center
Reno, Nevada, United States
Active, not recruiting
Dent Neurosciences Research Center, Inc.
Amherst, New York, United States
Active, not recruiting
Montefiore Medical Center
The Bronx, New York, United States
Recruiting
Carolina Institute for Clinical Research, LLC
Fayetteville, North Carolina, United States
Active, not recruiting
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Recruiting
Velocity Clinical Research
Cincinnati, Ohio, United States
Active, not recruiting
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Active, not recruiting
Coastal Pediatric Research
Charleston, South Carolina, United States
Active, not recruiting
Tribe Clinical Research LLC
Greenville, South Carolina, United States
Terminated
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, United States
Recruiting
Avera Research Institute
Sioux Falls, South Dakota, United States
Recruiting
Avera Medical Group Pediatrics - Dawley Farm
Sioux Falls, South Dakota, United States
Recruiting
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Terminated
Alina Clinical Trials, LLC.
Dallas, Texas, United States
Recruiting
North Texas Center for Clinical Research
Frisco, Texas, United States
Recruiting
DM Clinical Research - Cy Fair
Houston, Texas, United States
Recruiting
SCLA Management - Drop Box
Houston, Texas, United States
Recruiting
SCLA Management Office
Houston, Texas, United States
Recruiting
NeuroCare Plus
Houston, Texas, United States
Recruiting
Red Star Research, LLC
Lake Jackson, Texas, United States
Active, not recruiting
DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, United States
Recruiting
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, United States
Recruiting
Texas Institute for Neurological Disorders
Sherman, Texas, United States
Active, not recruiting
DM Clinical Research (Administrative Office Only)
Tomball, Texas, United States
Recruiting
Victoria Clinical Research Group
Victoria, Texas, United States
Terminated
Meridian Clinical Research, LLC
Portsmouth, Virginia, United States
Active, not recruiting
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada
Terminated
Centre Hospitalier Intercommunal de Creteil
Créteil, France
Recruiting
Centre Hospitalier Universitaire de Montpellier
Montpellier, France
Active, not recruiting
Hopital des Enfants
Toulouse, France
Recruiting
Showing 60 of 93 sites — filter to narrow it down. 61 of the 93 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT05156398. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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