Efficacy and Safety of Erenumab in Pediatric Subjects with Episodic Migraine

Phase 1

Conditions: Episodic migraine
MedDRA version: 20.0Level: PTClassification code 10027599Term: MigraineSystem Organ Class: 10029205 - Nervous system disorders
Therapeutic area: Diseases [C] - Nervous System Diseases [C10]

Registration Number: EUCTR2017-002397-39-PL

Lead Sponsor: Amgen Inc.

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: 456

Inclusion Criteria

101 Children (6 to < 12 years of age) or adolescent (12 to < 18 years of age) at the
time of signing, if developmentally appropriate, the formal assent to participate to the study.
102 Subject’s parent or legal representative has provided written informed consent before initiation of any study-specific activities/procedures.
103 History of migraine (with or without aura) for = 12 months before screening
according to the IHS Classification ICHD-3 based on medical records and/or subject self-report or parents’ or legal representative’s report
104 History of < 15 headache days per month of which = 4 headache days were
assessed by the subject as migraine days per month in each of the 3 months
prior to screening
105 Migraine frequency: . 4 and < 15 migraine days based on the eDiary
data during the last 28 days of the baseline phase if . 28 days in
duration.
106 Headache frequency: < 15 headache days based on the eDiary data
during the last 28 days of the baseline phase if . 28 days in duration.
107 Demonstrated at least 80% compliance with the eDiary based on the
last 28 days of the baseline period, if . 28 days in duration (eg,
completing eDiary items for at least 23 out of the last 28 days of the
baseline phase).
Are the trial subjects under 18? yes
Number of subjects for this age range:
F.1.2 Adults (18-64 years) no
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

201 History of cluster headache or hemiplegic migraine headache.
202 No therapeutic response with > 2 of the following 10 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial
203 Malignancy within 5 years before screening.
204 History of suicidal behavior or the subject is at risk of self-harm or harm to others as evidenced by endorsement of items 4 or 5 on the pediatric Columbia-suicide Severity Rating Scale (C-SSRS) assessed at screening.
205 Evidence of drug or alcohol abuse or dependence within 12 months before
screening, based on medical records, subject self-report, or positive urine drug
test performed during screening
206 Human immunodeficiency virus (HIV) infection by history.
207 History of seizure disorder or other significant neurological disorder other than migraine. Note: a single childhood febrile seizure is not exclusionary.
208 History of major psychiatric disorder
209 Use of prohibited medication within 1 month before the start of the baseline
phase and/or during the baseline phase
210 Use of prohibited devices (such as stimulation devices) or procedures (such as acupuncture, biofeedback, relaxation techniques, or psychotherapy) with the goal of preventing migraines, within 3 months before the start of the baseline phase and/or during the baseline phase Note: Subjects who have discontinued CBT within 3 months prior to the
start of the baseline phase are eligible for the study provided that there
is evidence of CBT failure/lack of efficacy prior to initial screening (per
medical records or investigator's assessment)
211 Received botulinum toxin in the head and/or neck region within 4 months before the start of the baseline phase or during the baseline phase.
212 Received medication targeting the CGRP pathway within 4 months before the start of the baseline phase or during the baseline phase.
213 Taken the following for any indication in any month during the 2 months before the start of the baseline phase or during the baseline phase :
• Ergotamines or triptans on = 10 days per month.
• Simple analgesics (nonsteroidal anti-inflammatory drugs [NSAIDs],
acetaminophen) on = 15 days per month.
• Opioid or butalbital-containing analgesics on = 4 days per month
214 Currently receiving treatment in another investigational device or drug study, or less than 90 days since ending treatment on another investigational device or drug study(ies). Other investigational procedures while participating in this study are excluded
215 Subject has clinically significant vital signs, laboratory results, or ECG
abnormality during screening that, in the opinion of the investigator, could pose a risk to subject safety or interfere with the study evaluation.
216 Hepatic disease by history or total bilirubin (TBL) = 2.0 x upper limit of normal (ULN) or alanine transaminase (ALT) or aspartate aminotransferase (AST)
= 3.0 x ULN, as assessed by the central laboratory at initial screening