A Phase 3, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Migraine Prevention
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 577
- 试验地点
- 1
- 主要终点
- Change From Baseline in Monthly Migraine Days at Week 12
研究概览
简要总结
To evaluate the effect of erenumab compared to placebo on the change from baseline in monthly migraine days, in adults with episodic migraine.
详细描述
Adults with a history of migraine with or without aura for ≥ 12 months and who experience ≥ 4 to < 15 migraine days per month with < 15 headache days per month will be randomized 1:1 to placebo or erenumab. Double-blind erenumab or placebo will be administered during the 12-week double-blind treatment phase and open-label erenumab will be administered during the 28-week open-label treatment phase.
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
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •History of migraines (with or without aura) for ≥ 12 months
- •Migraine frequency: ≥ 4 and < 15 migraine days per month on average acrossthe 3 months prior to screening
- •Headache (ie, migraine and non-migraine headache) frequency: < 15 headache days per month on average across the 3 months prior to screening
- •Demonstrated compliance with the eDiary
排除标准
- •Older than 50 years of age at migraine onset.
- •History of cluster headache or hemiplegic migraine headache.
- •Unable to differentiate migraine from other headaches
- •No therapeutic response with > 2 categories for prophylactic treatment of migraine after an adequate therapeutic trial.
- •Concomitant use of 2 or more medications with possible migraine prophylactic effects within 2 months prior to the start of the baseline phase or during the baseline phase. If only 1 prophylactic medication is used, the dose must be stable within 2 months prior to the start of the baseline phase and throughout the study
- •Used a prohibited medication, device, or procedure within 2 months prior to the start of the baseline phase or during the baseline phase.
- •Received botulinum toxin
- •Anticipated to require any excluded medication, device, or procedure during the study.
- •Active chronic pain syndromes (such as fibromyalgia and chronic pelvic pain).
- •History of major psychiatric disorder.
- •History of seizure disorder or other significant neurological conditions other than migraine.
- •Human immunodeficiency virus (HIV) infection by history.
- •Myocardial infarction (MI), stroke, transient ischemic attack (TIA), unstable angina, or coronary artery bypass surgery or other revascularization procedure within 12 months prior to screening.
- •The subject is at risk of self-harm or harm to others. Previously randomized into an AMG 334 study.
- •Unlikely to be able to complete all protocol required study visits or procedures, and/or to comply with all required study procedures.
研究组 & 干预措施
Placebo
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. At week 12 participants began treatment with erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the open-label treatment phase.
干预措施: Placebo (Drug)
Erenumab
Participants received erenumab 70 mg on day 1 and at weeks 4 and 8 by subcutaneous injection in the double-blind treatment phase. Participants continued to receive erenumab 70 mg administered by subcutaneous injection at weeks 12, 16, 20, 24, 28, 32, and 36 in the open-label treatment phase.
干预措施: Erenumab (Drug)
结局指标
主要结局
Change From Baseline in Monthly Migraine Days at Week 12
时间窗: 4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase
A migraine day was any calendar day in which the participant experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined either as a migraine with or without aura. The change from baseline in monthly migraine days was calculated as the number of migraine days during the last 4 weeks of the 12-week double-blind treatment phase - the number of migraine days during the 4-week baseline phase.
次要结局
- Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Week 12(4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase)
- Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days at Week 12(4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase)
- Percentage of Participants With at Least a 5-point Reduction From Baseline in Average Impact on Everyday Activities Domain Score Measured by MPFID at Week 12(4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase)
- Percentage of Participants With at Least a 5-Point Reduction From Baseline in Average Impact on Physical Impairment Domain Score Measured by MPFID at Week 12(4-week baseline phase and the last 4 weeks of the 12-week double-blind treatment phase)
- Number of Participants With Adverse Events(From first dose of study drug up to 12 weeks after the last dose. The double-blind treatment phase was 12 weeks and the open-label treatment phase was 28 weeks.)
- Number of Participants Who Developed Antibodies to Erenumab(Baseline (the period prior to the first dose erenumab 70 mg) and post-baseline (the period after the first dose of erenumab 70 mg until 12 weeks after last dose, up to 48 weeks total))