NCT03836040

Efficacy and Safety of Erenumab in Pediatric Participants With Episodic 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 Episodic Migraine (OASIS PEDIATRIC [EM])

• Status: Active Not Recruiting
• Phase: Phase 3
• Study type: Interventional
• Enrollment: 457 (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 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).

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 subjects 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: 2019-07-19
• Primary completion: 2025-11-19
• Completion: 2026-11-15
• First posted: 2019-02-11
• Last updated: 2025-12-23

Locations

119 sites across 16 countries: United States, Belgium, Canada, Colombia, Finland, Germany, Hungary, Italy, Japan, Poland, Portugal, Puerto Rico, Russia, Spain, Switzerland, United Kingdom

Regulatory

• FDA-regulated drug study