Tests rimegepant to prevent migraine in children and teens
Compares rimegepant with placebo to prevent migraine in children and adolescents aged 6 to 17.
Plain-language title generated from the registry record
Registry title: Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects
Key facts
- Where
- Amherst, Augusta, Boise, Charleston, Chicago, Cincinnati, Clinton, Colorado Springs, Columbia, Dallas, Detroit, Edgewater, Fayetteville, Fort Collins, Fort Smith, Frisco, Grand Island, Greenville, Hawthorne, Hialeah, Hollywood, Houston, La Mesa, Lake Jackson, McAllen, Minneapolis, Nashville, New Orleans, Oklahoma City, Ormond Beach, Papillion, Portsmouth, Reno, San Antonio, Sandy Springs, Savannah, Sherman, Sioux Falls, Snellville, Tamarac, Tampa, The Bronx, Tomball, Victoria, and Washington D.C., United StatesSee the 56 sites
- Phase
- Phase 3
Could this be for you?
Answer for yourself. This is not a decision: only the study team can say whether you can take part.
- Are you between 6 and 17 years old?
Source: NCT05156398, who can take part
Where in United States
- Dent Neurosciences Research Center, IncAmherst, United StatesNo longer taking part
- Augusta UniversityAugusta, United StatesTaking people
- Clinical Trial OfficeAugusta, United StatesTaking people
- Northwest Clinical Trials, Inc.Boise, United StatesTaking people
- Coastal Pediatric ResearchCharleston, United StatesNo longer taking part
- Diamond Headache ClinicChicago, United StatesNo longer taking part
- Cincinnati Children's Hospital Medical CenterCincinnati, United StatesTaking people
- Velocity Clinical ResearchCincinnati, United StatesNo longer taking part
- Safe Haven Clinical ResearchClinton, United StatesNo longer taking part
- Colorado Springs Neurological AssociatesColorado Springs, United StatesNo longer taking part
- Roy Blunt NextGen Precision Health BuildingColumbia, United StatesTaking people
- University of MissouriColumbia, United StatesTaking people
- University of Missouri Health Care - Investigation PharmacyColumbia, United StatesTaking people
- University of Missouri-Clinical and Translational Sciences UnitColumbia, United StatesTaking people
- Alina Clinical Trials, LLC.Dallas, United StatesTaking people
- NRST - DetroitDetroit, United StatesNot yet recruiting
- Accel Research Sites Network - Edgewater Clinical Research UnitEdgewater, United StatesNo longer taking part
- Carolina Institute for Clinical Research, LLCFayetteville, United StatesNo longer taking part
- Advanced Neurosciences Research, LlcFort Collins, United StatesNo longer taking part
- The Belinga ClinicFort Smith, United StatesNo longer taking part
- North Texas Center for Clinical ResearchFrisco, United StatesTaking people
- Velocity Clinical Research - Grand IslandGrand Island, United StatesTaking people
- Tribe Clinical Research LLCGreenville, United StatesNo longer taking part
- Advanced Investigative Medicine, Inc.Hawthorne, United StatesTaking people
- Direct Helpers Research CenterHialeah, United StatesTaking people
- New Med Research, IncHollywood, United StatesNo longer taking part
- DM Clinical Research - Cy FairHouston, United StatesTaking people
- NeuroCare PlusHouston, United StatesTaking people
- SCLA Management - Drop BoxHouston, United StatesTaking people
- SCLA Management OfficeHouston, United StatesTaking people
- Velocity Clinical Research, San DiegoLa Mesa, United StatesNo longer taking part
- Red Star Research, LLCLake Jackson, United StatesNo longer taking part
- DCT-McAllen Primary Care Research, LLC dba Discovery Clinical TrialsMcAllen, United StatesTaking people
- Clinical Research InstituteMinneapolis, United StatesNot yet recruiting
- Monroe Carell Jr. Children's Hospital at VanderbiltNashville, United StatesNo longer taking part
- Nola Research Works, LLCNew Orleans, United StatesTaking people
- Lynn Health Science InstituteOklahoma City, United StatesNo longer taking part
- Complete Health ResearchOrmond Beach, United StatesNo longer taking part
- Papillion Research Center/CCT ResearchPapillion, United StatesTaking people
- Meridian Clinical Research, LLCPortsmouth, United StatesNo longer taking part
- Renown Regional Medical CenterReno, United StatesNo longer taking part
- DCT-Stone Oak, LLC dba Discovery Clinical TrialsSan Antonio, United StatesTaking people
- WR-Mount Vernon Clinical Research, LLCSandy Springs, United StatesNo longer taking part
- Meridian Clinical Research, LLCSavannah, United StatesNo longer taking part
- Texas Institute for Neurological DisordersSherman, United StatesNo longer taking part
- Avera McKennan Hospital & University Health CenterSioux Falls, United StatesTaking people
- Avera Medical Group Pediatrics - Dawley FarmSioux Falls, United StatesTaking people
- Avera Research InstituteSioux Falls, United StatesTaking people
- Extraordinary Family HealthcareSnellville, United StatesNo longer taking part
- Renew Health Clinical Research LLCSnellville, United StatesNo longer taking part
- D&H Tamarac Research Center, LLCTamarac, United StatesTaking people
- Santos Research Center, CORPTampa, United StatesTaking people
- Montefiore Medical CenterThe Bronx, United StatesTaking people
- DM Clinical Research (Administrative Office Only)Tomball, United StatesTaking people
- Victoria Clinical Research GroupVictoria, United StatesNo longer taking part
- Velocity Clinical Research, Washington DCWashington D.C., United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Pfizer
- Trial code
- NCT05156398EU 2024-512382-13-00
- Record updated
- 14 October 2026
- Original description
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.Read full original descriptionShow less
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
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.
Inclusion: Subject has at least a 6 month history of migraine (with or without aura) and including the following:; 14 or less headache days per month during the 3 month period prior to the Screening Visit; 6 or more migraine days during the Observation Period; 14 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; 3)Subjects must have a weight of ≥40 kg (child cohort requirement ≥15 kg) at the Screening Visit.
Exclusion: The subject has a continuous migraine (defined as an unrelenting headache) within 1 month prior to Screening Visit; 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; Subjects with a history of basilar migraine, cluster headaches, or hemiplegic migraine; The subject has a confounding and clinically significant pain syndrome that may interfere with the subject's ability to participate in this study; 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; The subject has a history or diagnosis of complications of migraine.