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Clinical Trials in the UK / NCT04649242
Recruiting Phase 3

Randomized Study in Children and Adolescents With Migraine: Acute Treatment

NCT04649242 · tracked via the Priya Life Science UK tracker
Sponsor
Pfizer
Phase
Phase 3
Started
2021-01-15
Last updated
2026-08-14

Condition(s) studied

Pediatric Migraine

Investigational drug(s) / intervention(s)

Rimegepant/BHV3000Matching placebo

Rimegepant/BHV3000: BHV3000 (rimegepant) 75 mg or 50 mg ODT

Matching placebo: Matching 75 mg or 50 mg ODT placebo

Study summary

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.

Eligibility

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

Primary outcome measure(s)

Trial sites (245)

FacilityCityRegionStatus
Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of Alabama Birmingham Alabama Active Not Recruiting
Perseverance Research Center, LLC Scottsdale Arizona Recruiting
Physicians Research Group Tempe Arizona Active Not Recruiting
Advanced Research Center, Inc. Anaheim California Recruiting
Adult & Child Neurology Medical Associates Costa Mesa California Recruiting
ProScience Research Group Culver City California Active Not Recruiting
Memorial Health Services Fountain Valley California Recruiting
Neuro-Pain Research Center Fresno California Recruiting
Altman Clinical and Translational Research Institute, University of California San Diego La Jolla California Recruiting
Adult & Child Neurology Medical Associates Long Beach California Recruiting
Miller Children's & Women's Hospital Long Beach Long Beach California Recruiting
National Research Institute Los Angeles California Active Not Recruiting
Velocity Clinical Research - North Hollywood North Hollywood California Active Not Recruiting
Children's Hospital of Orange County - Inpatient Pharmacy Orange California Not Yet Recruiting
Children's Hospital of Orange County - Neuroscience Center Orange California Not Yet Recruiting
Children's Hospital of Orange County Orange California Not Yet Recruiting
The Neurology Group Pomona California Recruiting
University of California, Davis Midtown Clinic Sacramento California Active Not Recruiting
UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy Sacramento California Active Not Recruiting
University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC) Sacramento California Active Not Recruiting
Velocity Clinical Research, San Bernardino (IP Delivery and Administering Location) San Bernardino California Recruiting
Pacific Clinical Research Management Group LLC Upland California Active Not Recruiting
Sunwise Clinical Research Walnut Creek California Recruiting
Children's Hospital Colorado- lnvestigational Drug Services Aurora Colorado Recruiting
Children's Hospital Colorado Aurora Colorado Recruiting
Colorado Springs Neurological Associates, PC Colorado Springs Colorado Active Not Recruiting
Colorado Springs Neurological Associates, PC Colorado Springs Colorado Active Not Recruiting
CT Clinical Research Cromwell Connecticut Recruiting
Connecticut Children's Medical Center Hartford Connecticut Active Not Recruiting
Ki Health Partners, LLc, dba New England Institute for Clinical Research Stamford Connecticut Recruiting
Nemours Children's Hospital, Delaware Wilmington Delaware Active Not Recruiting
Children's National Medical Center Washington D.C. District of Columbia Recruiting
Topaz Clinical Research, Inc. Apopka Florida Active Not Recruiting
Beautiful Minds Clinical Research Center Cutler Bay Florida Terminated
DeLand Clinical Research Unit DeLand Florida Terminated
Sarkis Clinical Trials Gainesville Florida Active Not Recruiting
Multi-Specialty Research Associates, Inc. Lake City Florida Active Not Recruiting
Watson Clinic Center for Research, Inc. Lakeland Florida Terminated
Watson Clinic LLP Lakeland Florida Terminated
AppleMed Research Group, LLC Miami Florida Active Not Recruiting

+ 205 more sites — see the full list on the official registry below.

More Pfizer trials in the UK

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 NCT04649242 on ClinicalTrials.gov ↗ ← All trials in the UK