A Phase 3 interventional study of Erenumab Dose 1 and Erenumab Dose 2 in Migraine, sponsored by Amgen. Completed at 101 sites in 13 countries. Open to participants aged 6 Years to 17 Years. Per ClinicalTrials.gov, last updated 2026-01-20.
Sponsored by Amgen · Phase 3, Interventional, and Treatment
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 chronic migraine. The study hypothesis is that in pediatric participants with chronic 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).
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 chronic 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 subjects; 12-weeks for Group 2 subjects) 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 enrol 286 participants (256 adolescents and 30 children).
1,528 studies on the registry are indexed under Migraine Disorders; 299 are open to participants now.
This study's enrollment of 284 is above the median of 80 across 1,175 interventional studies indexed under Migraine Disorders.
Browse Migraine Disorders studies →Amgen is the lead sponsor of 1,015 studies on the registry; 49 are open to participants now.
Of its 245 completed or terminated interventional studies of FDA-regulated products, 159 (65%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion Criteria:
Key Exclusion Criteria:
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.
Drug: Erenumab Dose 1 · Drug: 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.
Drug: Erenumab Dose 2 · Drug: Erenumab Dose 3
Other: Placebo
Participants in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.
Also known as: AMG 334, Aimovig®
Participants in the low body-weight group at day 1 who are randomized to Dose Level 2 and participants in the high body-weight group at day 1 who are randomized to Dose Level 1 will receive this dose.
Also known as: AMG 334, Aimovig®
Participants in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.
Also known as: AMG 334, Aimovig®
Placebo matching dose for erenumab dose 1, 2 and 3.
Change from baseline in MMDs
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 DBTP.
Time frame: Baseline through week 12 of DBTP
Change in monthly headache days from baseline
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 DBTP.
Time frame: Baseline through week 12 of the DBTP
Proportion of participants with at least 50% reduction in MMDs from baseline
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.
Time frame: Baseline through week 12 of the DBTP
Change in MMDs from baseline to the average of the first 3 months
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.
Time frame: Baseline through week 12 of the DBTP
Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)
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 an electronic diary (eDiary) with a visual analogue scale.
Time frame: Baseline through week 12 of the double blind treatment phase
Change from baseline in migraine-related disability and productivity as assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)
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.
Time frame: Baseline through week 12 of the DBTP
Number of participants experiencing Treatment-emergent Adverse Events (TEAE)
TEAEs are any event that occurred after the participant received study treatment. Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration were recorded as TEAEs. A serious TEAE is any untoward medical occurrence in a clinical study participant after first dose irrespective of a causal relationship with the study treatment(s) that resulted in death, was immediately life threatening, required in-patient hospitalization or prolongation of existing hospitalization, resulted in persistent or significant disability/incapacity, a congenital anomaly/birth defect, or another medically important serious event.
Time frame: Up to Week 83
Number of participants expressing C Terminal Telopeptide of Type 1 Collagen (CTX) Markers
Time frame: Up to week 83
Number of participants expressing Procollagen Type 1 N Propeptide (P1NP) Markers
Time frame: Up to week 83
Number of participants expressing Anti-erenumab antibodies
Time frame: Up to week 83
Change in growth and development rate as assessed by physical measuraments based on age-adjusted Z-scores for height and weight
Time frame: Up to week 83
Number of participants experiencing treatment-emergent suicidal ideation and behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).
Time frame: Up to week 83
Group 1 only: Number of participants experiencing injection site pain as assessed by Face Pain Scale-revised (FPS-R)
Time frame: Day 1 and week 20
Group 2 only: Number of participants experiencing injection site pain as assessed by FPS-R
Time frame: Day 1 and week 8
Showing the first 100 of 101 sites across 13 countries.
Plan to share: Yes — De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Supporting information: Study protocol, Sap, Icf, Csr
This study is completed, as verified in Jan 2026. You cannot join it, but the record below documents what was studied.
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