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NCT03836040 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine
A Phase 3 study of Migraine, sponsored by Amgen.
- Active
- Registry status
- Phase 3
- Development phase
- 457
- Enrollment target
- 20
- Study locations
NCT03836040: Active Phase 3 study of Migraine, sponsored by Amgen.
NCT03836040 is a Phase 3 study of Migraine that is active but no longer recruiting, run by Amgen. The registered enrollment target is 457 participants, above the 354-participant average among 102 other Migraine trials with a reported enrollment target (29% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT03836040, a Phase 3 study of Migraine, is active but no longer recruiting, sponsored by Amgen.
- ACTIVE NOT RECRUITING
- Registry status
- Phase 3
- Development phase
- 457 participants
- Enrollment target
- 20
- Study locations
Study Summary
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).
Primary Outcome
To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to week 9 through week 12 (month 3) of the double-blind treatment period (DBTP).
Conditions Studied
Interventions
- OTHER Placebo
- DRUG Erenumab Dose 1
- DRUG Erenumab Dose 2
- DRUG Erenumab Dose 3
Study Locations (20)
Florida
- Northwest Florida Clinical Research Group Limited Liability Company - Gulf Breeze
- Nicklaus Childrens Hospital - Miami
- Pediatric Epilepsy and Neurology Specialists - Tampa
- TrueBlue Clinical Research - Tampa
- Premiere Research Institute - West Palm Beach
Colorado
- Childrens Hospital Colorado - Aurora
- Colorado Springs Neurological Associates - Colorado Springs
Georgia
- Rare Disease Research Center Pediatrics - Atlanta
- CenExel iResearch, LLC - Savannah
Illinois
- Northwestern University - Chicago
- Chicago Headache Center and Research Institute - Chicago
California
- Paradigm Clinical Research Center Inc - San Diego
Connecticut
- New England Institute for Clinical Research - Stamford
District of Columbia
- Childrens National Health System - Washington D.C.
Indiana
- Josephson Wallack Munshower Neurology - Indianapolis
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 457 participants |
| Start Date | 2019-07-19 |
| Est. Completion | 2026-11-15 |
| Phase | Phase 3 |
What the registry record for NCT03836040 still lists
NCT03836040 is an interventional study that assigns participants to a tested intervention. The registered 457 participants enrollment target is mid-sized for trials with a published cap, above the 354-participant average among 102 other Migraine trials with a reported enrollment target (29% higher).
The record links to 1 condition, with Migraine appearing as the primary indexed condition, and to 4 interventions - of which Placebo is the first listed.
NCT03836040 names 20 study sites across 13 states, led by Florida, Colorado, Georgia.
Frequently Asked Questions
What is clinical trial NCT03836040 about?
NCT03836040 is a clinical study titled "Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine". 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 r...
What is the current status of trial NCT03836040?
This trial is currently active not recruiting. It is a Phase 3 study. The enrollment target is 457 participants. The study started on 2019-07-19. Estimated completion is 2026-11-15.
What conditions does trial NCT03836040 study?
This clinical trial studies the following conditions: Migraine.
What interventions are being tested in trial NCT03836040?
The interventions under investigation include: Placebo (OTHER), Erenumab Dose 1 (DRUG), Erenumab Dose 2 (DRUG), Erenumab Dose 3 (DRUG).
Who is sponsoring clinical trial NCT03836040?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT03836040 being conducted?
This trial has 20 study locations across California, Colorado, Connecticut, District of Columbia, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Migraine
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT03836040's enrollment target sits among peer trials
457 26th of 102 higher than 77 of 102 other Migraine trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Migraine 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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