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 Chronic Migraine (OASIS PEDIATRIC [CM])
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 284
- 试验地点
- 101
- 主要终点
- Change from baseline in MMDs
研究概览
简要总结
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 participants 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).
详细描述
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 DBTP (24 weeks for Group 1 subjects; 12-weeks for Group 2 subjects) 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 enrol 286 participants (256 adolescents and 30 children).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
- •Participant'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 (participants 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 participant 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).
排除标准
- •History of cluster headache or hemiplegic migraine headache.
- •Chronic migraine with continuous pain, in which the participant 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 participant is at risk of self-harm or harm to others.
- •History of major psychiatric disorder. Participants with anxiety disorder and/or mild major depressive disorder (Patient Health Questionnaire Modified for Adolescents [PHQ-A] score 9 for adolescents or based on medical judgement of the investigator for children) 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. Participants must have been on a stable dose within the 3 months before the start of the baseline phase.
研究组 & 干预措施
Dose Level 2
Participants will be randomized to one of two doses determined by their body-weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.
干预措施: Erenumab Dose 2 (Drug)
Placebo
干预措施: Placebo (Other)
Dose Level 2
Participants will be randomized to one of two doses determined by their body-weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.
干预措施: Erenumab Dose 3 (Drug)
Dose Level 1
Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.
干预措施: Erenumab Dose 1 (Drug)
Dose Level 1
Participants will be randomized to one of two doses determined by their body weight at Day 1. Participants who enrolled under the original protocol or protocol amendment 1 will be identified as group 1. Those enrolled under protocol amendment 2 will be identified as group 2.
干预措施: Erenumab Dose 2 (Drug)
结局指标
主要结局
Change from baseline in MMDs
时间窗: Baseline through week 12 of DBTP
To evaluate the effect of erenumab compared with placebo on the change in MMDs from baseline to week 9 through week 12 (month 3) of DBTP.
次要结局
- Number of participants experiencing Treatment-emergent Adverse Events (TEAE)(Up to Week 83)
- Number of participants expressing C Terminal Telopeptide of Type 1 Collagen (CTX) Markers(Up to week 83)
- Change in monthly average severity of migraine attacks from baseline (measured with a visual analogue scale)(Baseline through week 12 of the double blind treatment phase)
- Number of participants expressing Procollagen Type 1 N Propeptide (P1NP) Markers(Up to week 83)
- Change in monthly headache days from baseline(Baseline through week 12 of the DBTP)
- Proportion of participants with at least 50% reduction in MMDs from baseline(Baseline through week 12 of the DBTP)
- Change from baseline in migraine-related disability and productivity as assessed by the Pediatric Migraine Disability Assessment (PedMIDAS)(Baseline through week 12 of the DBTP)
- Number of participants experiencing treatment-emergent suicidal ideation and behavior as assessed by the Columbia Suicide Severity Rating Scale (C-SSRS).(Up to week 83)
- Group 2 only: Number of participants experiencing injection site pain as assessed by FPS-R(Day 1 and week 8)
- Change in growth and development rate as assessed by physical measuraments based on age-adjusted Z-scores for height and weight(Up to week 83)
- Change in MMDs from baseline to the average of the first 3 months(Baseline through week 12 of the DBTP)
- Number of participants expressing Anti-erenumab antibodies(Up to week 83)
- Group 1 only: Number of participants experiencing injection site pain as assessed by Face Pain Scale-revised (FPS-R)(Day 1 and week 20)