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
4 other identifiers
interventional
640
7 countries
90
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_3
Started Feb 2022
Longer than P75 for phase_3
90 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
November 19, 2021
CompletedFirst Posted
Study publicly available on registry
December 14, 2021
CompletedStudy Start
First participant enrolled
February 28, 2022
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 29, 2031
ExpectedStudy Completion
Last participant's last visit for all outcomes
November 27, 2032
April 16, 2026
April 1, 2026
9.8 years
November 19, 2021
April 15, 2026
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Change from baseline in the mean number of migraine days per month as measured over the 12-week double-blind phase of the study in adolescents with episodic migraine
Reduction from baseline in mean number of migraine days per month
3 months (12 weeks)
Secondary Outcomes (8)
Achievement of at least a 50% reduction from baseline in mean monthly migraine days over the course of the double-blind phase in adolescents with episodic migraine
3 months (12 weeks)
Change from baseline in the mean number of migraine days per month in the first 4 weeks (Weeks 1 through 4) of the double-blind treatment phase in adolescents with episodic migraine.
Weeks 1 through 4 of treatment
The mean change from baseline in the Pediatric Quality of Life (PedsQL™) total score at Week 12 of the double-blind treatment phase in adolescents with episodic migraine.
Total score at week 12
Change from baseline in the mean number of migraine days per month over the entire course of the double-blind treatment phase in children and children and adolescents combined with episodic migraine.
3 months (12 weeks)
Change from baseline on the proportion of subjects that have at least a 50% reduction in the mean number of moderate to severe migraine days per month.
3 months (12 weeks)
- +3 more secondary outcomes
Study Arms (2)
Rimegepant / BHV3000
ACTIVE COMPARATORRimegepant 75mg or 50mg (2 X 25mg) ODT
Matching Placebo
PLACEBO COMPARATORMatching placebo 75mg or 50mg (2 X 25mg) ODT
Interventions
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Eligibility Criteria
You may qualify if:
- Subject has at least a 6 month history of migraine (with or without aura) and including the following:
- or less headache days per month during the 3 month period prior to the Screening Visit
- or more migraine days during the Observation Period
- or less headache days during the Observation Period
- 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
- Ability to verbally distinguish migraine attacks from tension/cluster or other types of headaches
- Migraine attacks, on average, lasting 4 - 72 hours if untreated
- 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.
- )Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.
You may not qualify if:
- Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine
- The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit.
- The subject has a history or diagnosis of complications of migraine
- The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study.
- 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.
- History of suicidal behavior or the subject is at risk of self-harm or harm to others.
- History of major psychiatric disorder.
- The subject has a current diagnosis or history of substance abuse
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Pfizerlead
Study Sites (90)
The Belinga Clinic
Fort Smith, Arkansas, 72901, United States
Advanced Investigative Medicine, Inc.
Hawthorne, California, 90250, United States
Velocity Clinical Research San Diego
La Mesa, California, 91942, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, 80907, United States
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, 80528, United States
Meridian Clinical Research, LLC
Washington D.C., District of Columbia, 20016, United States
Accel Research Sites Network - Edgewater Clinical Research Unit
Edgewater, Florida, 32132, United States
Direct Helpers Research Center
Hialeah, Florida, 33012, United States
New Med Research, Inc
Hollywood, Florida, 33020, United States
Complete Health Research
Ormond Beach, Florida, 32174, United States
D&H Tamarac Research Center LLC
Tamarac, Florida, 33321, United States
Santos Research Center, CORP
Tampa, Florida, 33615, United States
Augusta University
Augusta, Georgia, 30912, United States
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, 30328, United States
Meridian Clinical Research, LLC
Savannah, Georgia, 31406, United States
Extraordinary Family Healthcare
Snellville, Georgia, 30078, United States
Renew Health Clinical Research LLC
Snellville, Georgia, 30078, United States
Northwest Clinical Trials, Inc.
Boise, Idaho, 83704, United States
Diamond Headache Clinic
Chicago, Illinois, 60642, United States
Nola Research Works, LLC
New Orleans, Louisiana, 70125, United States
Safe Haven Clinical Research
Clinton, Mississippi, 39056, United States
Roy Blunt NextGen Precision Health Building
Columbia, Missouri, 65211, United States
University of Missouri Health Care - Investigation Pharmacy
Columbia, Missouri, 65212, United States
University of Missouri-Clinical and Translational Sciences Unit
Columbia, Missouri, 65212, United States
Velocity Clinical Research, Grand Island
Grand Island, Nebraska, 68803, United States
Papillion Research Center/CCT Research
Papillion, Nebraska, 68046, United States
Renown Regional Medical Center
Reno, Nevada, 89502, United States
Dent Neurosciences Research Center, Inc.
Amherst, New York, 14226, United States
Montefiore Medical Center
The Bronx, New York, 10461, United States
Carolina Institute for Clinical Research, LLC
Fayetteville, North Carolina, 28303, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, 45229, United States
Velocity Clinical Research
Cincinnati, Ohio, 45242, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, 73112, United States
Coastal Pediatric Research
Charleston, South Carolina, 29414, United States
Tribe Clinical Research LLC
Greenville, South Carolina, 29607, United States
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, 57105, United States
Avera Research Institute
Sioux Falls, South Dakota, 57108, United States
Avera Medical Group Pediatrics - Dawley Farm
Sioux Falls, South Dakota, 57110, United States
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, 37232, United States
Alina Clinical Trials, LLC.
Dallas, Texas, 75209, United States
North Texas Center for Clinical Research
Frisco, Texas, 75034, United States
DM Clinical Research - Cy Fair
Houston, Texas, 77065, United States
SCLA Management - Drop Box
Houston, Texas, 77077, United States
SCLA Management Office
Houston, Texas, 77077, United States
NeuroCare Plus
Houston, Texas, 77094, United States
Red Star Research, LLC
Lake Jackson, Texas, 77566, United States
DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, 78503, United States
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, 78258, United States
Texas Institute for Neurological Disorders
Sherman, Texas, 75092, United States
DM Clinical Research (Administrative Office Only)
Tomball, Texas, 77375, United States
Victoria Clinical Research Group
Victoria, Texas, 77901, United States
Meridian Clinical Research, LLC
Portsmouth, Virginia, 23703, United States
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, V6H 3V4, Canada
Centre Hospitalier Intercommunal de Créteil
Créteil, 94000, France
Centre Hospitalier Universitaire de Montpellier
Montpellier, 34295, France
Hopital des Enfants
Toulouse, 31059, France
UOSVD Centro Epilessia ed EEG dellEta Evolutiva
Bari, BARI / Puglia, 70132, Italy
Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic
Latina, Latina/lazio, 04100, Italy
IRCCS San Raffaele
Rome, Lazio, 00166, Italy
Istituto Neurologico "Carlo Besta" Fondazione IRCCS
Milan, Lombardy, 20133, Italy
Divisione di Neurologia, Ospedale Pediatrico Bambino Gesu
Rome, Rome/lazio, 00165, Italy
ASST Spedali Civili di Brescia
Brescia, 25069, Italy
Jinnouchi Neurosurgical Clinic
Kasuga-shi, Fukuoka, 816-0802, Japan
Hikita Pediatric Clinic
Kiryu-shi, Gunma, 376-0035, Japan
Konan Medical Center
Higashinada-ku Kobe-shi, Hyōgo, 658-0064, Japan
Yamaguchi Clinic
Nishinomiya-shi, Hyōgo, 663-8204, Japan
Mito Kyodo General Hospital
Mito, Ibaraki, 310-0015, Japan
Tanaka Neurosurgery & Headache Clinic
Kagoshima, Kagoshima-ken, 890-0052, Japan
Atago Hospital
Kochi, Kochi, 780-0051, Japan
Sendai Headache and Neurology Clinic
Taihaku-ku Sendai-shi, Miyagi, 982-0014, Japan
Tennouji Dai Brain Clinic
Abeno-ku Osaka-shi, Osaka, 545-0053, Japan
Tominaga Clinic
Naniwa-ku, Osaka, 556-0015, Japan
Saitama Neuropsychiatric Institute
Chuo-ku Saitama-shi, Saitama, 338-8577, Japan
Tokyo Headache Clinic
Shibuya-ku, Tokyo, 151-0051, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, 160-0023, Japan
LIAC Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
Hiroshima, 730-8518, Japan
Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
Poznan, Greater Poland Voivodeship, 61-731, Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy
Krakow, Lesser Poland Voivodeship, 31-503, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, Lower Silesian Voivodeship, 52-210, Poland
NZOZ Neuromed M. i M. Nastaj Sp. P.
Lublin, Lublin Voivodeship, 20-064, Poland
MTZ Clinical Research Powered by Pratia
Warsaw, Masovian Voivodeship, 02-172, Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
Katowice, Silesian Voivodeship, 40-123, Poland
Neurologia Slaska Centrum Medyczne
Katowice, Silesian Voivodeship, 40-689, Poland
Next Stage Sp. Z o.o.
Warsaw, WOJ. Mazowieckie, 02-121, Poland
Hospital Universitari Parc Tauli
Sabadell, Barcelona, 08208, Spain
Hospital Clinico Universitario de Valladolid (HCUV)
Valladolid, Castille and León, 47003, Spain
Hospital Alvaro Cunqueiro
Vigo, Galicia, 36312, Spain
Instituto de Investigaciones del Sueno
Madrid, 28036, Spain
Virgen del Rocio Hospital
Seville, 41013, Spain
Hospital Universitario y Politecnico La Fe
Valencia, 46026, Spain
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Pfizer CT.gov Call Center
Pfizer
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- QUADRUPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- SEQUENTIAL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
November 19, 2021
First Posted
December 14, 2021
Study Start
February 28, 2022
Primary Completion (Estimated)
November 29, 2031
Study Completion (Estimated)
November 27, 2032
Last Updated
April 16, 2026
Record last verified: 2026-04
Data Sharing
- IPD Sharing
- Will share
Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical\_trials/trial\_data\_and\_results/data\_requests.