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NCT04649242 · ClinicalTrials.gov registry record · Phase 3
Randomized Study in Children and Adolescents With Migraine: Acute Treatment
A Phase 3 study of Pediatric Migraine, sponsored by Pfizer.
- Recruiting
- Registry status
- Phase 3
- Development phase
- 2,100
- Enrollment target
- 20
- Study locations
NCT04649242: Recruiting Phase 3 study of Pediatric Migraine, sponsored by Pfizer.
NCT04649242 is a Phase 3 study of Pediatric Migraine that is actively recruiting participants, run by Pfizer. The registered enrollment target is 2,100 participants, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (172% higher). The trial reports 20 study locations across 3 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04649242, a Phase 3 study of Pediatric Migraine, is actively recruiting participants, sponsored by Pfizer.
- RECRUITING
- Registry status
- Phase 3
- Development phase
- 2,100 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
Pain freedom will be assessed in adolescent population (≥ 12 to \< 18 years of age) on a 4-point numeric rating scale (0=none, 1=mild, 2=moderate, 3=severe).
Conditions Studied
Interventions
- DRUG Matching placebo
- DRUG Rimegepant/BHV3000
Study Locations (20)
California
- Advanced Research Center, Inc. - Anaheim
- Adult & Child Neurology Medical Associates - Costa Mesa
- ProScience Research Group - Culver City
- Memorial Health Services - Fountain Valley
- Neuro-Pain Medical Center - Fresno
- Regents of the University of California (UC San Diego) - La Jolla
- Adult & Child Neurology Medical Associates - Long Beach
- Miller Children's & Women's Hospital Long Beach - Long Beach
- National Research Institute - Los Angeles
- Velocity Clinical Research - North Hollywood - North Hollywood
- Children's Hospital of Orange County - Inpatient Pharmacy - Orange
- Children's Hospital of Orange County - Neuroscience Center - Orange
- Children's Hospital of Orange County - Orange
- The Neurology Group - Pomona
- University of California, Davis Midtown Clinic - Sacramento
- UC Davis Medical Center, Investigational Drug Service (IDS) Pharmacy - Sacramento
- University of California, Davis Clinical and Translational Science Center Clinical Research (CCRC) - Sacramento
Arizona
- Perseverance Research Center, LLC - Scottsdale
- Physicians Research Group - Tempe
Alabama
- Achieve Clinical Research, LLC d/b/a Accel Research Sites-Neurology and Neurodiagnostic of Alabama - Birmingham
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 2,100 participants |
| Start Date | 2021-01-15 |
| Est. Completion | 2029-01-09 |
| Phase | Phase 3 |
What NCT04649242 shows while recruiting
NCT04649242 is an interventional study that assigns participants to a tested intervention. Its 2,100 participants enrollment target places it among the larger protocols in the corpus, above the 772-participant average among 15,282 other Phase 3 trials with a reported enrollment target (172% higher).
The record links to 1 condition, with Pediatric Migraine appearing as the primary indexed condition, and to 2 interventions - of which Matching placebo is the first listed.
NCT04649242 names 20 study sites across 3 states, led by California, Arizona, Alabama.
Frequently Asked Questions
What is clinical trial NCT04649242 about?
NCT04649242 is a clinical study titled "Randomized Study in Children and Adolescents With Migraine: Acute Treatment". 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.
What is the current status of trial NCT04649242?
This trial is currently recruiting. It is a Phase 3 study. The enrollment target is 2,100 participants. The study started on 2021-01-15. Estimated completion is 2029-01-09.
What conditions does trial NCT04649242 study?
This clinical trial studies the following conditions: Pediatric Migraine.
What interventions are being tested in trial NCT04649242?
The interventions under investigation include: Matching placebo (DRUG), Rimegepant/BHV3000 (DRUG).
Who is sponsoring clinical trial NCT04649242?
This trial is sponsored by Pfizer, which has 1,845 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT04649242 being conducted?
This trial has 20 study locations across Alabama, Arizona, California. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04649242's enrollment target sits among peer trials
2,100 98th of 2000 higher than 1,903 of 2,000 other Phase 3 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 3 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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