NCT04649242From ClinicalTrials.govRecruiting

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

Phase 3, Multicenter, Randomized, Double-blind, Group Sequential, Placebo-controlled Study to Assess Efficacy and Safety of Rimegepant for the Treatment of Migraine (With or Without Aura) in Children and Adolescents ≥ 6 to < 18 Years of Age

Pediatric Migraine

At a glance

Phase: Phase 3
Study type: Interventional
Sponsor: Pfizer
Enrolment target: 2,100
Started: 15 January 2021
Main results due: 9 January 2029
Study sites: 246
Registry updated: 24 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. History of migraine (with or without aura) for \> 6 months before Screening according to the IHS Classification ICHD-319 specifications for pediatric migraine. History may be verified using both medical records and recall by the participant and/or participant's parent(s)/legal representative(s).
2. History of 1 to 8 moderate or severe attacks per month during the 2 months prior to enrollment, with attacks lasting \> 3 hours without treatment, and attacks occurring at intervals \> 24 hours.
3. Prophylactic migraine medication are permitted if the dose has been stable for at least 12 weeks prior to the Baseline Visit, and the dose is not expected to change during the course of the study.

1. Participants may remain on one (1) medication with possible migraine prophylactic effects, excluding CGRP antagonists \[biologic or small molecule\], during the treatment phases.
2. Concomitant use of a CGRP antagonist, such as erenumab or fremanezumab, is prohibited.
3. Previously discontinued prophylactic migraine medication must have done so at least 90 days prior to the Screening Visit.
4. Verbally distinguish between migraine and other types of headaches.
5. Participants must have a weight \> 40 kg at the Screening Visit.
6. Adequate venous access for blood sampling.
7. Male and female participants ≥ 6 to \< 18 years of age (participants must not reach their 18th birthday during the study).

Exclusion Criteria:

1. History of cluster headache or hemiplegic migraine headache.
2. Confounding and clinically significant pain syndrome that may interfere with the participant's ability to participate in this study.
3. Current psychiatric condition that is uncontrolled and/or untreated for a minimum of 6 months prior to the Screening Visit. Participants with a lifetime history of psychosis and/or mania.
4. History of suicidal behavior or major psychiatric disorder.
5. Current diagnosis or history of substance abuse; positive drug test at Screening.
6. History of moderate or severe head trauma or other neurological disorder (including seizure disorder) or systemic medical disease that is likely to affect central nervous system functioning.
7. Recent or planned surgery, requiring general anesthesia, \<8 weeks prior to the Screening Visit.
8. Participant has had gastrointestinal surgery that interferes with physiological absorption and motility (i.e., gastric bypass, duodenectomy, or gastric banding).
9. Current diagnosis of viral hepatitis or a history of liver disease.
10. Conditions considered clinically relevant in the context of the study such as uncontrolled hypertension (high blood pressure), diabetes, a life-threatening allergy

What this study is about

In the sponsor’s own words, from the registry.

The purpose of this study is to test the safety and efficacy of BHV-3000 versus placebo in the acute treatment of moderate or severe migraine in children and adolescents.

Study sites(246)

Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of Alabama
Birmingham, Alabama, United States
Active, not recruiting
Perseverance Research Center, LLC
Scottsdale, Arizona, United States
Recruiting
Physicians Research Group
Tempe, Arizona, United States
Active, not recruiting
Advanced Research Center, Inc.
Anaheim, California, United States
Recruiting
Adult & Child Neurology Medical Associates
Costa Mesa, California, United States
Recruiting
ProScience Research Group
Culver City, California, United States
Active, not recruiting
Memorial Health Services
Fountain Valley, California, United States
Recruiting
Neuro-Pain Research Center
Fresno, California, United States
Recruiting
Altman Clinical and Translational Research Institute, University of California San Diego
La Jolla, California, United States
Recruiting
Adult & Child Neurology Medical Associates
Long Beach, California, United States
Recruiting
Miller Children's & Women's Hospital Long Beach
Long Beach, California, United States
Recruiting
National Research Institute
Los Angeles, California, United States
Active, not recruiting
Velocity Clinical Research - North Hollywood
North Hollywood, California, United States
Active, not recruiting
Children's Hospital of Orange County - Inpatient Pharmacy
Orange, California, United States
Not yet recruiting
Children's Hospital of Orange County - Neuroscience Center
Orange, California, United States
Not yet recruiting
Children's Hospital of Orange County
Orange, California, United States
Not yet recruiting
The Neurology Group
Pomona, California, United States
Recruiting
University of California, Davis Midtown Clinic
Sacramento, California, United States
Active, not recruiting
UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy
Sacramento, California, United States
Active, not recruiting
University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC)
Sacramento, California, United States
Active, not recruiting
Velocity Clinical Research, San Bernardino
San Bernardino, California, United States
Active, not recruiting
Pacific Clinical Research Management Group LLC
Upland, California, United States
Active, not recruiting
Sunwise Clinical Research
Walnut Creek, California, United States
Recruiting
Children's Hospital Colorado- lnvestigational Drug Services
Aurora, Colorado, United States
Recruiting
Children's Hospital Colorado
Aurora, Colorado, United States
Recruiting
Colorado Springs Neurological Associates, PC
Colorado Springs, Colorado, United States
Active, not recruiting
Colorado Springs Neurological Associates, PC
Colorado Springs, Colorado, United States
Active, not recruiting
CT Clinical Research
Cromwell, Connecticut, United States
Recruiting
Connecticut Children's Medical Center
Hartford, Connecticut, United States
Active, not recruiting
Ki Health Partners, LLc, dba New England Institute for Clinical Research
Stamford, Connecticut, United States
Recruiting
Nemours Children's Hospital, Delaware
Wilmington, Delaware, United States
Active, not recruiting
Children's National Medical Center
Washington D.C., District of Columbia, United States
Recruiting
Topaz Clinical Research, Inc.
Apopka, Florida, United States
Active, not recruiting
Beautiful Minds Clinical Research Center
Cutler Bay, Florida, United States
Terminated
DeLand Clinical Research Unit
DeLand, Florida, United States
Terminated
Sarkis Clinical Trials
Gainesville, Florida, United States
Active, not recruiting
Multi-Specialty Research Associates, Inc.
Lake City, Florida, United States
Active, not recruiting
Watson Clinic Center for Research, Inc.
Lakeland, Florida, United States
Terminated
Watson Clinic LLP
Lakeland, Florida, United States
Terminated
AppleMed Research Group, LLC
Miami, Florida, United States
Active, not recruiting
Medical Research Center of Miami II, Inc
Miami, Florida, United States
Active, not recruiting
South Florida Research Phase I-IV, Inc
Miami, Florida, United States
Recruiting
Brainstorm Research
Miami, Florida, United States
Active, not recruiting
Advanced Research for Health Improvement, LLC/ Dr. Cordero's Pediatric Office
Naples, Florida, United States
Active, not recruiting
Aqualane Clinical Research
Naples, Florida, United States
Recruiting
Coastal Clinical Research Specialists
Orange Park, Florida, United States
Active, not recruiting
Clinical Associates of Orlando, LLC
Orlando, Florida, United States
Recruiting
Bioresearch Institute
Pembroke Pines, Florida, United States
Terminated
Forcare Clinical Research
Tampa, Florida, United States
Active, not recruiting
Premiere Research Institute at Palm Beach Neurology
West Palm Beach, Florida, United States
Active, not recruiting
Children's Healthcare of Atlanta, Inc.
Atlanta, Georgia, United States
Active, not recruiting
Childrens Healthcare of Atlanta
Atlanta, Georgia, United States
Active, not recruiting
Rare Disease Research, LLC
Atlanta, Georgia, United States
Active, not recruiting
Pivotal Clinical Research & Associates, LLC
Brunswick, Georgia, United States
Active, not recruiting
CenExel iResearch, LLC
Decatur, Georgia, United States
Recruiting
Chicago Headache Center & Research Institute
Chicago, Illinois, United States
Recruiting
AMR-Baber Research Inc
Naperville, Illinois, United States
Recruiting
Options Research Group, LLC
Westfield, Indiana, United States
Recruiting
Velocity Clinical Research, Sioux City
Sioux City, Iowa, United States
Recruiting
Integrated Clinical Trial Services
West Des Moines, Iowa, United States
Recruiting

Showing 60 of 246 sites — filter to narrow it down. 123 of the 246 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 NCT04649242. 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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