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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 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.
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).
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 |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT03836040
The ClinicalTrials.gov registry entry for NCT03836040 describes a study currently listed as active not recruiting, categorized as Phase 3. The registered enrollment target is 457 participants, a figure that helps gauge the scale of data the investigators plan to collect, above the 354-participant average among 102 other Migraine trials with a reported enrollment target (29% higher). The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
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 reports 20 study locations spanning 13 distinct geographic areas - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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