NCT03832998

Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study to Evaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Chronic Migraine (OASIS PEDIATRIC [CM])

• Status: Completed
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 284 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 6 Years – 17 Years
• Healthy volunteers: Not accepted

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 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).

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 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).

Conditions

• Migraine

Interventions

Type	Name	Description
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 participants 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.
OTHER	Placebo	Placebo matching dose for erenumab dose 1, 2 and 3.

Timeline

• Start date: 2019-09-05
• Primary completion: 2025-01-08
• Completion: 2026-01-07
• First posted: 2019-02-06
• Last updated: 2026-01-20

Locations

101 sites across 13 countries: United States, Belgium, Canada, Colombia, Finland, Germany, Hungary, Italy, Japan, Poland, Puerto Rico, Russia, United Kingdom

Regulatory

• FDA-regulated drug study