Efficacy and Safety of Erenumab in Pediatric Subjects With Episodic Migraine
Efficacy and Safety of Erenumab in Pediatric Subjects With Episodic Migraine
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).
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 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 456 participants (376 adolescents and up to 80 children).
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 during
 the baseline phase based on the eDiary calculations.

 -  Headache frequency: < 15 headache days during the baseline phase based on the eDiary
 calculations.

 -  Demonstrated at least 80% compliance with the eDiary (eg, completing eDiary items for
 at least 23 out of 28 days during 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.