Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine
Running, not enrolling · Phase 3 · Has a placebo group
Conditions studied: Migraine
In brief
This study will evaluate the efficacy and safety of erenumab in migraine prevention in children (6 to \<12 years) and adolescents (12 to \<18 years) with episodic migraine. The study hypothesis is that in pediatric participants with episodic migraine, the combined erenumab dose group has a greater reduction from baseline to week 9 through week 12 (month 3) in monthly migraine days (MMDs) when compared with placebo in the double-blind treatment phase (DBTP).
Key facts
- Study ID
- NCT03836040
- Run by
- Amgen
- People needed
- 457
- Starts
- 2019-07-19
- Expected to finish
- 2026-11-19
- Last updated by the study team
- 2026-07-16
Who can join
Age: 6 and older, up to 17. Sex: any. Healthy volunteers: not accepted.
Where it is running
- Childrens Hospital Colorado — Aurora, Colorado, United States
- Colorado Springs Neurological Associates — Colorado Springs, Colorado, United States
- New England Institute for Clinical Research — Stamford, Connecticut, United States
- Childrens National Health System — Washington D.C., District of Columbia, United States
- Northwest Florida Clinical Research Group Limited Liability Company — Gulf Breeze, Florida, United States
- Nicklaus Childrens Hospital — Miami, Florida, United States
- Pediatric Epilepsy and Neurology Specialists — Tampa, Florida, United States
- TrueBlue Clinical Research — Tampa, Florida, United States
- Premiere Research Institute — West Palm Beach, Florida, United States
- Rare Disease Research Center Pediatrics — Atlanta, Georgia, United States
- CenExel iResearch, LLC — Savannah, Georgia, United States
- Northwestern University — Chicago, Illinois, United States
- Chicago Headache Center and Research Institute — Chicago, Illinois, United States
- Josephson Wallack Munshower Neurology — Indianapolis, Indiana, United States
- University of Maryland, Baltimore — Baltimore, Maryland, United States
- New England Regional Headache Center Inc — Worcester, Massachusetts, United States
- Michigan Head Pain and Neurological Institute — Ann Arbor, Michigan, United States
- Clinical Research Institute Inc — Minneapolis, Minnesota, United States
- Childrens Mercy Hospital and Clinics — Kansas City, Missouri, United States
- Mercy Research — St Louis, Missouri, United States
- Velocity Clinical Research, Inc — Grand Island, Nebraska, United States
- Dent Neurosciences Research Center — Amherst, New York, United States
- Modern Migraine MD — New York, New York, United States
- Columbia University Irving Medical Center — New York, New York, United States
- Paradigm Clinical Research Center Inc — San Diego, California, United States
Full record on ClinicalTrials.gov
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