Efficacy and Safety of Erenumab in Pediatric Subjects With Episodic Migraine

• Status: Recruiting
• Trial end date: 2025-12-14
• Target enrollment: 0
• Participant gender: All

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 subjects 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).

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amgen
• Collaborator: Novartis
• Treatments: Antibodies, Monoclonal; Erenumab

Criteria

Inclusion Criteria:

• Children (6 to less than 12 years of age) or adolescent (12 to less than 18 years of age) at the time of signing, if developmentally appropriate, the formal assent to participate to the study.

• Subject's parent or legal representative has provided written informed consent before initiation of any study specific activities/procedures.

• History of migraine (with or without aura) for greater than or equal to 12 months before screening according to the IHS Classification ICHD-3 (Headache Classification Committee of the International Headache Society, 2013) ICHD-3 specifications for pediatric migraine (subjects aged less than 18 years), should be considered for the diagnosis of migraine

• History of less than 15 headache days per month of which greater than or equal to 4 headache days were assessed by the subject as migraine days per month in each of the 3 months prior to screening.

• Migraine frequency: greater than or equal to 4 and less than 15 migraine days based on the eDiary data during the the last 28 days of the baseline phase if more than 28 days in duration.

• Headache frequency: < 15 headache days based on the eDiary data during the last 28 days of the baseline phase if more than 28 days in duration.

• Demonstrated at least 80% compliance with the eDiary based on the last 28 days of the baseline period, if more than 28 days in duration (eg, completing eDiary items for at least 23 out of the last 28 days of the baseline phase).

Key Exclusion Criteria:

• History of cluster headache or hemiplegic migraine headache.

• No therapeutic response with greater than 2 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial.

No therapeutic response is defined as no reduction in headache frequency, duration, or severity after administration of the medication for at least 6 weeks at the generally-accepted therapeutic dose(s) based on the investigator's assessment.

• History of suicidal behavior or the subject is at risk of self-harm or harm to others.

• History of major psychiatric disorder. Subjects with anxiety disorder and/or mild major depressive disorder (with PHQ-A score 9) are permitted in the study if they are considered by the investigator to be stable and are taking no more than 1 medication for each disorder. Subjects must have been on a stable dose within the 3 months before the start of the baseline phase.