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Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine

NCT03836040 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 457

Last updated 2025-12-23

No results posted yet for this 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

Interventions

OTHER

Placebo

Placebo matching dose for erenumab dose 1, 2 and 3.

DRUG

Erenumab Dose 1

Participants in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.

DRUG

Erenumab Dose 2

Participants in the low body-weight group at day 1 who are randomized to Dose Level 2 and subjects in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose.

DRUG

Erenumab Dose 3

Participants in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
17 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-19
Primary Completion
2025-11-19
Completion
2026-11-15
FDA Drug
Yes

Countries

  • United States
  • Belgium
  • Canada
  • Colombia
  • Finland
  • Germany
  • Hungary
  • Italy
  • Japan
  • Poland
  • Portugal
  • Puerto Rico
  • Russia
  • Spain
  • Switzerland
  • United Kingdom

Study Locations

More Related Trials

Entities

Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03836040 on ClinicalTrials.gov