Efficacy and Safety of Erenumab in Pediatric Participants With Episodic Migraine

Phase 3

Recruiting

• Conditions: Migraine
• Interventions: Drug: Erenumab Dose 1; Other: Placebo; Drug: Erenumab Dose 2; Drug: Erenumab Dose 3

• Registration Number: NCT03836040
• Lead Sponsor: Amgen

Brief 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).

Detailed Description

This study is a Phase 3, randomized, double-blind, placebo-controlled, parallel-group study to 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 trial consists of four phases: screening (up to 3 weeks of initial screening and a 4-week prospective baseline phase); the DBTP (24 weeks for Group 1 participants; 12-weeks for Group 2 participants) in which participants receive placebo or Erenumab dose 1, dose 2 or dose 3 (based on participant's body weight) via subcutaneous injection once a month; the optional dose level blinded extension phase (40 weeks), in which all participants are assigned to receive dose 1, dose 2 or dose 3 of Erenumab; and a 12 weeks safety follow-up phase (16 weeks after the last dose of investigational drug).

The study intends to enroll 436 participants (376 adolescents and up to 60 children).

Study Timeline

• Study First Submitted: 2019-01-29
• Study First Submitted QC: 2019-02-07
• Study First Posted: 2019-02-11
• Study Start: 2019-07-19
• Status Verified: 2025-07
• Last Update Submitted: 2025-07-16
• Last Update Posted: 2025-07-18
• Primary Completion: 2025-12-19
• Study Completion: 2026-12-17

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 436

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Dose level 1	Erenumab Dose 1	Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.
Dose level 1	Erenumab Dose 2	Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.
Dose level 2	Erenumab Dose 3	Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.
Dose level 2	Erenumab Dose 2	Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.
Placebo	Placebo	Participants will be randomized to a placebo comparator.

Primary Outcome Measures

Name	Time	Method
Change from baseline in MMDs	Baseline through week 12 of the double blind treatment phase	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).

Secondary Outcome Measures

Name	Time	Method
Change in monthly headache days from baseline	Baseline through week 12 of the double blind treatment phase	To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly headache days to week 9 through week 12 (month 3) of the DBTP
Proportion of participants with at least 50% reduction in MMDs from baseline	Baseline through week 12 of the double blind treatment phase	To evaluate the effect of erenumab compared with placebo on the proportion of participants with at least 50% reduction in MMDs from baseline to week 9 through week 12 (month 3) of the DBTP
Change in MMDs from baseline to the average of the first 3 months	Baseline through week 12 of the double blind treatment phase	To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to the average of the first 3 months (week 1 through week 12) of the DBTP
Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)	Baseline through week 12 of the double blind treatment phase	To evaluate the effect of erenumab compared with placebo on the change from baseline in monthly average severity of migraine attacks to week 9 through week 12 (month 3) of the DBTP. This will be measured in a daily electronic diary (eDiary) with a visual analogue scale.
Change from baseline in migraine-related disability and productivity	Baseline through week 12 of the double blind treatment phase	To evaluate the effect of erenumab compared with placebo on the change from baseline in migraine-related disability and productivity as measured by the modified PedMIDAS to week 9 through week 12 (month 3) of the DBTP.
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)	Up to week 80	Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration will be recorded as TEAEs.
Number of Participants Expressing C Terminal Telopeptide of Type 1 Collagen (CTX) Markers	Up to week 64
Number of Participants Expressing Procollagen Type 1 N Propeptide (P1NP) Markers	Up to week 64
Number of Participants Expressing Anti-erenumab Antibodies	Up to week 80
Change in Growth and Development Rate as Assessed by Physical Measurements Based on Age-adjusted Z-scores for Height and Weight	Up to week 80
Number of Participants Experiencing Treatment-emergent Suicidal Ideation and Behavior as Assessed by the Columbia Suicide Severity Rating Scale (C-SSRS)	Up to week 64
Group 1 Only: Number of Participants Experiencing Injection Site Pain as Assessed by Face Pain Scale-revised (FPS-R)	Day 1 and week 20
Group 2 Only: Number of Participants Experiencing Injection Site Pain as Assessed by FPS-R	Day 1 and week 8

Trial Locations

Locations (119)

Paradigm Clinical Research Center Inc; 🇺🇸 San Diego, California, United States

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, 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

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