A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group Study toEvaluate the Efficacy and Safety of Erenumab in Children (6 to < 12 Years) and Adolescents (12 to < 18 Years) With Episodic Migraine (OASIS PEDIATRIC [EM])

Amgen Inc.0 个研究点目标入组 456 人开始时间: 2019年3月27日最近更新: 2024年7月29日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方
入组人数: 456

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•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 (Headache
•Classification Committee of the International Headache Society, 2013)
•based on medical records and/or subject self-report or parents' or legal
•representative's report.
•The following ICHD-3 specifications for pediatric migraine (subjects
•aged < 18 years), should be considered for the diagnosis of migraine:
•Attacks may last 2 to 72 hours.
•Migraine headache is more often bilateral than in adults; unilateral
•pain usually emerges in late adolescence or early adult life.
•Migraine headache is usually frontotemporal. Occipital headache in
•children is rare and calls for diagnostic caution.
•A subset of otherwise typical subjects have facial location of pain,
•which is called 'facial migraine' in the literature; there is no evidence
•that these subjects form a separate subgroup of migraine subjects.
•In young children, photophobia and phonophobia may be inferred from
•their behaviour.
•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 (refer to Section 5.6 for definition of
•migraine day).
•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
•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

排除标准

•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 15 days 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
•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
•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
•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

研究者

发起方

Amgen Inc.

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