Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
NCT ID: NCT05156398
Last Updated: 2025-11-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
PHASE3
640 participants
INTERVENTIONAL
2022-02-28
2032-11-27
Brief Summary
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Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
SEQUENTIAL
PREVENTION
QUADRUPLE
Study Groups
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Rimegepant / BHV3000
Rimegepant 75mg or 50mg (2 X 25mg) ODT
Rimegepant
Rimegepant 75mg or 50mg (2 X 25mg) ODT
Matching Placebo
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Placebo
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Interventions
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Rimegepant
Rimegepant 75mg or 50mg (2 X 25mg) ODT
Placebo
Matching placebo 75mg or 50mg (2 X 25mg) ODT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
6 Years
17 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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The Belinga Clinic
Fort Smith, Arkansas, United States
Advanced Investigative Medicine, Inc.
Hawthorne, California, United States
Velocity Clinical Research San Diego
La Mesa, California, United States
Colorado Springs Neurological Associates
Colorado Springs, Colorado, United States
Advanced Neurosciences Research, LLC
Fort Collins, Colorado, United States
Meridian Clinical Research, LLC
Washington D.C., District of Columbia, United States
Synergy Healthcare
Bradenton, Florida, United States
Accel Research Sites Network - Edgewater Clinical Research Unit
Edgewater, Florida, United States
Direct Helpers Research Center
Hialeah, Florida, United States
New Med Research, Inc
Hollywood, Florida, United States
Complete Health Research
Ormond Beach, Florida, United States
D&H Tamarac Research Center LLC
Tamarac, Florida, United States
Santos Research Center, CORP
Tampa, Florida, United States
Augusta University
Augusta, Georgia, United States
WR-Mount Vernon Clinical Research, LLC
Sandy Springs, Georgia, United States
Meridian Clinical Research, LLC
Savannah, Georgia, United States
Extraordinary Family Healthcare
Snellville, Georgia, United States
Renew Health Clinical Research LLC
Snellville, Georgia, United States
Northwest Clinical Trials, Inc.
Boise, Idaho, United States
Diamond Headache Clinic
Chicago, Illinois, United States
Nola Research Works, LLC
New Orleans, Louisiana, United States
Safe Haven Clinical Research
Clinton, Mississippi, United States
Roy Blunt NextGen Precision Health Building
Columbia, Missouri, United States
University of Missouri Health Care - Investigation Pharmacy
Columbia, Missouri, United States
University of Missouri-Clinical and Translational Sciences Unit
Columbia, Missouri, United States
Velocity Clinical Research, Inc.
Grand Island, Nebraska, United States
Papillion Research Center/CCT Research
Papillion, Nebraska, United States
Renown Regional Medical Center
Reno, Nevada, United States
Dent Neurosciences Research Center, Inc.
Amherst, New York, United States
Montefiore Medical Center
The Bronx, New York, United States
Carolina Institute for Clinical Research, LLC
Fayetteville, North Carolina, United States
Cincinnati Children's Hospital Medical Center
Cincinnati, Ohio, United States
Velocity Clinical Research
Cincinnati, Ohio, United States
Lynn Health Science Institute
Oklahoma City, Oklahoma, United States
Coastal Pediatric Research
Charleston, South Carolina, United States
Tribe Clinical Research LLC
Greenville, South Carolina, United States
Avera McKennan Hospital & University Health Center
Sioux Falls, South Dakota, United States
Avera Research Institute
Sioux Falls, South Dakota, United States
Avera Medical Group Pediatrics - Dawley Farm
Sioux Falls, South Dakota, United States
Monroe Carell Jr Children's Hospital at Vanderbilt
Nashville, Tennessee, United States
Alina Clinical Trials, LLC.
Dallas, Texas, United States
North Texas Center for Clinical Research
Frisco, Texas, United States
DM Clinical Research - Cy Fair
Houston, Texas, United States
SCLA Management - Drop Box
Houston, Texas, United States
SCLA Management Office
Houston, Texas, United States
NeuroCare Plus
Houston, Texas, United States
Red Star Research, LLC
Lake Jackson, Texas, United States
DCT-McAllen Primary Care Research, LLC dba Discovery Clinical Trials
McAllen, Texas, United States
DCT-Stone Oak, LLC dba Discovery Clinical Trials
San Antonio, Texas, United States
Texas Institute for Neurological Disorders
Sherman, Texas, United States
DM Clinical Research (Administrative Office Only)
Tomball, Texas, United States
Victoria Clinical Research Group
Victoria, Texas, United States
Meridian Clinical Research, LLC
Portsmouth, Virginia, United States
Children's and Women's Health Centre of British Columbia
Vancouver, British Columbia, Canada
Centre Hospitalier Intercommunal de Créteil
Créteil, , France
Centre Hospitalier Universitaire de Montpellier
Montpellier, , France
Hopital des Enfants
Toulouse, , France
UOSVD Centro Epilessia ed EEG dellEta Evolutiva
Bari, BARI / Puglia, Italy
Spedali Civili di Brescia
Brescia, Brescia/lombardy, Italy
Sapienza Universita di Roma Polo Pontino - ICOT, Headache clinic
Latina, Latina/lazio, Italy
Ospedale Pediatrico Bambino Gesu
Rome, Lazio, Italy
IRCCS San Raffaele
Rome, Lazio, Italy
Istituto Neurologico "Carlo Besta" Fondazione IRCCS
Milan, Lombardy, Italy
U.O. Neuropsichiatria Infantile, IRCCS Fondazione Mondino
Pavia, Lombardy, Italy
Jinnouchi Neurosurgical Clinic
Kasuga-shi, Fukuoka, Japan
Hikita Pediatric Clinic
Kiryu-shi, Gunma, Japan
Konan Medical Center
Higashinada-ku Kobe-shi, Hyōgo, Japan
Yamaguchi Clinic
Nishinomiya-shi, Hyōgo, Japan
Mito Kyodo General Hospital
Mito, Ibaraki, Japan
Tanaka Neurosurgery & Headache Clinic
Kagoshima, Kagoshima-ken, Japan
Atago Hospital
Kochi, Kochi, Japan
Sendai Headache and Neurology Clinic
Taihaku-ku Sendai-shi, Miyagi, Japan
Tennouji Dai Brain Clinic
Abeno-ku Osaka-shi, Osaka, Japan
Tominaga Clinic
Naniwa-ku, Osaka, Japan
Saitama Neuropsychiatric Institute
Chuo-ku Saitama-shi, Saitama, Japan
Tokyo Headache Clinic
Shibuya-ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
LIAC Hiroshima City Hospital Organization Hiroshima City Hiroshima Citizens Hospital
Hiroshima, , Japan
Clinical Research Center Sp. z o.o. MEDIC-R Sp. k.
Poznan, Greater Poland Voivodeship, Poland
Wojewodzki Specjalistyczny Szpital Dzieciecy
Krakow, Lesser Poland Voivodeship, Poland
MIGRE Polskie Centrum Leczenia Migreny Anna Gryglas-Dworak
Wroclaw, Lower Silesian Voivodeship, Poland
NZOZ Neuromed M. i M. Nastaj Sp. P.
Lublin, Lublin Voivodeship, Poland
MTZ Clinical Research Powered by Pratia
Warsaw, Masovian Voivodeship, Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska SYNAPSIS
Katowice, Silesian Voivodeship, Poland
Neurologia Slaska Centrum Medyczne
Katowice, Silesian Voivodeship, Poland
Next Stage Sp. Z o.o.
Warsaw, WOJ. Mazowieckie, Poland
Hospital Universitari Parc Tauli
Sabadell, Barcelona, Spain
Hospital Clinico Universitario de Valladolid (HCUV)
Valladolid, Castille and León, Spain
Hospital Alvaro Cunqueiro
Vigo, Galicia, Spain
Instituto de Investigaciones del Sueno
Madrid, , Spain
Virgen del Rocio Hospital
Seville, , Spain
Hospital Universitario y Politecnico La Fe
Valencia, , Spain
Countries
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Central Contacts
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Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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C4951009
Identifier Type: OTHER
Identifier Source: secondary_id
2021-005246-15
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
2021-005246-15
Identifier Type: REGISTRY
Identifier Source: secondary_id
2024-512382-13-00
Identifier Type: REGISTRY
Identifier Source: secondary_id
BHV3000-315
Identifier Type: -
Identifier Source: org_study_id