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).
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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
457
Participants in the low body-weight group at day 1 and who are randomized to Dose Level 1 will receive this dose.
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.
Participants in the high body-weight group at day 1 who are randomized to Dose Level 2 will receive this dose.
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 the double-blind treatment period (DBTP).
Time frame: Baseline through week 12 of the double blind treatment phase
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 the DBTP
Time frame: Baseline through week 12 of the double blind treatment phase
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 double blind treatment phase
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 double blind treatment phase
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 a daily electronic diary (eDiary) with a visual analogue scale.
Time frame: Baseline through week 12 of the double blind treatment phase
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Placebo matching dose for erenumab dose 1, 2 and 3.
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 D.C., 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
...and 109 more locations
Change from baseline in migraine-related disability and productivity
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 double blind treatment phase
Number of Participants Experiencing Treatment-emergent Adverse Events (TEAEs)
Any clinically significant changes in vital signs, electrocardiograms, and clinical laboratory tests that occurred after study treatment administration will be recorded as TEAEs.
Time frame: Up to week 80
Change from baseline in C Terminal Telopeptide of Type 1 Collagen (CTX) Markers at assessment time points
Time frame: Up to week 64
Change from baseline in Procollagen Type 1 N Propeptide (P1NP) Markers at assessment time points
Time frame: Up to week 64
Number of Participants Expressing Anti-erenumab Antibodies
Time frame: 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
Time frame: 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)
Time frame: Up to week 64
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