Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic MigraineOASIS(CM)
Study Details
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).
Protocol Summary
Change from baseline in MMDs
Timeframe: Baseline through week 12 of DBTP
Change in monthly headache days from baseline
Timeframe: Baseline through week 12 of the DBTP
Proportion of participants with at least 50% reduction in MMDs from baseline
Timeframe: Baseline through week 12 of the DBTP
Change in MMDs from baseline to the average of the first 3 months
Timeframe: Baseline through week 12 of the DBTP
Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)
Timeframe: 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)
Timeframe: Baseline through week 12 of the DBTP
Number of participants experiencing Treatment-emergent Adverse Events (TEAE)
Timeframe: Up to Week 83
Number of participants expressing C Terminal Telopeptide of Type 1 Collagen (CTX) Markers
Timeframe: Up to week 83
Number of participants expressing Procollagen Type 1 N Propeptide (P1NP) Markers
Timeframe: Up to week 83
Number of participants expressing Anti-erenumab antibodies
Timeframe: 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
Timeframe: 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).
Timeframe: Up to week 83
Group 1 only: Number of participants experiencing injection site pain as assessed by Face Pain Scale-revised (FPS-R)
Timeframe: Day 1 and week 20
Group 2 only: Number of participants experiencing injection site pain as assessed by FPS-R
Timeframe: Day 1 and week 8