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

AMGEN INC.0 个研究点目标入组 456 人开始时间: 2020年10月7日最近更新: 2021年8月30日

适应症

试验速览

暂无简介。

•- 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.
•- 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 based on medical records
•and/or subject self-report or parents' or legal representative's report.
•- 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.
•- Migraine frequency: > = 4 and < 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
•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

•- History of cluster headache or hemiplegic migraine headache.
•- No therapeutic response with > 2 of the following 10 medication categories for prophylactic treatment of migraine after an adequate therapeutic trial
•- Malignancy within 5 years before screening.
•- 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
•- 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
•*Please, refers to protocol for the full list

发起方

AMGEN INC.