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Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine
NCT03836040 · View on ClinicalTrials.gov ↗
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 |
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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. It is categorized as Phase 3, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 457 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 266 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
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. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT03836040 reports 20 study locations spanning 13 distinct geographic areas — top geographies include Florida, Colorado, Georgia. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
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. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
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). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT03836040?
This trial is sponsored by Amgen, which has 266 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
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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