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Clinical Trials in the USA / NCT05156398
Recruiting Phase 3

Efficacy and Safety Study of Rimegepant for the Preventative Treatment of Migraine in Pediatric Subjects

NCT05156398 · tracked via the Priya Life Science USA tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2022-02-28
Last updated
2026-08-24

Condition(s) studied

Migraine

Investigational drug(s) / intervention(s)

RimegepantPlacebo

Rimegepant: Rimegepant 75mg or 50mg (2 X 25mg) ODT

Placebo: Matching placebo 75mg or 50mg (2 X 25mg) ODT

Study 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.

Eligibility

Sex
ALL
Min age
6 Years
Max age
17 Years
Healthy volunteers
No
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.

Primary outcome measure(s)

Trial sites (93)

FacilityCityRegionStatus
The Belinga Clinic Fort Smith Arkansas Active Not Recruiting
Advanced Investigative Medicine, Inc. Hawthorne California Recruiting
Velocity Clinical Research San Diego La Mesa California Active Not Recruiting
Colorado Springs Neurological Associates Colorado Springs Colorado Active Not Recruiting
Advanced Neurosciences Research, LLC Fort Collins Colorado Terminated
Velocity Clinical Research, Washington DC Washington D.C. District of Columbia Recruiting
Accel Research Sites Network - Edgewater Clinical Research Unit Edgewater Florida Active Not Recruiting
Direct Helpers Research Center Hialeah Florida Recruiting
New Med Research, Inc Hollywood Florida Terminated
Complete Health Research Ormond Beach Florida Active Not Recruiting
D&H Tamarac Research Center LLC Tamarac Florida Recruiting
Santos Research Center, CORP Tampa Florida Recruiting
Clinical Trial Office Augusta Georgia Recruiting
Augusta University Augusta Georgia Recruiting
WR-Mount Vernon Clinical Research, LLC Sandy Springs Georgia Active Not Recruiting
Meridian Clinical Research, LLC Savannah Georgia Active Not Recruiting
Extraordinary Family Healthcare Snellville Georgia Active Not Recruiting
Renew Health Clinical Research LLC Snellville Georgia Active Not Recruiting
Northwest Clinical Trials, Inc. Boise Idaho Recruiting
Diamond Headache Clinic Chicago Illinois Terminated
Nola Research Works, LLC New Orleans Louisiana Recruiting
NRST - Detroit Highland Park Michigan Not Yet Recruiting
Clinical Research Institute Minneapolis Minnesota Not Yet Recruiting
Safe Haven Clinical Research Clinton Mississippi Terminated
Roy Blunt NextGen Precision Health Building Columbia Missouri Recruiting
University of Missouri Health Care - Investigation Pharmacy Columbia Missouri Recruiting
University of Missouri-Clinical and Translational Sciences Unit Columbia Missouri Recruiting
University of Missouri Columbia Missouri Recruiting
Velocity Clinical Research, Grand Island Grand Island Nebraska Recruiting
Papillion Research Center/CCT Research Papillion Nebraska Recruiting
Renown Regional Medical Center Reno Nevada Active Not Recruiting
Dent Neurosciences Research Center, Inc. Amherst New York Active Not Recruiting
Montefiore Medical Center The Bronx New York Recruiting
Carolina Institute for Clinical Research, LLC Fayetteville North Carolina Active Not Recruiting
Cincinnati Children's Hospital Medical Center Cincinnati Ohio Recruiting
Velocity Clinical Research Cincinnati Ohio Active Not Recruiting
Lynn Health Science Institute Oklahoma City Oklahoma Active Not Recruiting
Coastal Pediatric Research Charleston South Carolina Active Not Recruiting
Tribe Clinical Research LLC Greenville South Carolina Terminated
Avera McKennan Hospital & University Health Center Sioux Falls South Dakota Recruiting

+ 53 more sites — see the full list on the official registry below.

On this site

📄 Nurtec ODT (rimegepant) drug profile →

More Pfizer trials in the USA

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT05156398 on ClinicalTrials.gov ↗ ← All trials in the USA