Efficacy and Safety of Erenumab in Pediatric Subjects With Chronic Migraine

  • STATUS
    Recruiting
  • End date
    Nov 13, 2025
  • participants needed
    286
  • sponsor
    Amgen
Updated on 2 September 2021
headache
erenumab
chronic migraine

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 subjects 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).

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 double-blind treatment phase (24 weeks) 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 286 participants (256 adolescents and 30 children).

Details
Condition Migraine, Primary Stabbing Headache, Migraine (Adult), Migraine and Cluster Headaches, Migraine (Pediatric), migraines
Treatment Placebo, Erenumab Dose 1, Erenumab Dose 2, Erenumab Dose 3
Clinical Study IdentifierNCT03832998
SponsorAmgen
Last Modified on2 September 2021

Eligibility

Yes No Not Sure

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 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 15 headache days per month of which 8 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 8 migraine days based on the eDiary data during the last 28 days of the baseline phase if more than 28 days in duration
Headache frequency of greater than or equal to 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)

Exclusion Criteria

History of cluster headache or hemiplegic migraine headache
Chronic migraine with continuous pain, in which the subject does not have any pain free periods (of any duration) during the 1 month prior to screening
No therapeutic response with greater than 3 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 (Patient Health Questionnaire Modified for Adolescents [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
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