A Phase 2, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of AMG 334 in Chronic Migraine Prevention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 667
- 试验地点
- 1
- 主要终点
- Change From Baseline in Monthly Migraine Days
研究概览
简要总结
To evaluate the effect of erenumab compared to placebo on the change from baseline in the number of monthly migraine days in adults with chronic migraine.
详细描述
This study consisted of the following phases: screening, 4-week baseline phase, 12-week double-blind treatment, and 12-week follow-up. Participants may have elected to participate in the optional pharmacokinetic substudy and the optional, novel patient-reported outcome (PRO) assessment substudy.
Participants who completed the 12-week double-blind treatment phase of Study 20120295 were eligible to enroll in an open-label extension study (Study 20130255; NCT02174861).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Triple (Participant, 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 at least 5 attacks of migraine without aura and/or migraine with visual sensory, speech and/or language, retinal or brainstem aura.
- •History of ≥ 15 headache days per month of which ≥ 8 headache days were assessed by the subject as migraine day.
- •≥ 4 distinct headache episodes, each lasting ≥ 4 hours OR if shorter, associated with use of a triptan or ergot-derivative on the same calendar day based on the eDiary calculations.
- •Demonstrated at least 80% compliance with the eDiary.
排除标准
- •History of cluster headache or hemiplegic migraine headache
- •Unable to differentiate migraine from other headaches
- •Failed > 3 medication categories due to lack of efficacy for prophylactic treatment of migraine .
- •Received botulinum toxinin head or neck region within 4 months prior to screening.
- •Used a prohibited migraine prophylactic medication, device or procedure within 2 months prior to the start of the baseline phase
研究组 & 干预措施
Placebo
Participants received placebo on day 1 and at weeks 4 and 8 by subcutaneous injection.
干预措施: Placebo (Drug)
Erenumab 70 mg
Participants received 70 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
干预措施: Erenumab (Biological)
Erenumab 140 mg
Participants received 140 mg erenumab on day 1 and at weeks 4 and 8 by subcutaneous injection.
干预措施: Erenumab (Biological)
结局指标
主要结局
Change From Baseline in Monthly Migraine Days
时间窗: 4-week baseline phase and the last 4 weeks of the 12-week 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 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 in Monthly Migraine Days From Baseline(4-week baseline phase and the last 4 weeks of the 12-week treatment phase)
- Number of Participants With Adverse Events(From the first dose of study drug up to 16 weeks after the last dose (24 weeks))
- Number of Participants Who Developed Antibodies to Erenumab(Baseline and weeks 2, 4, 8, 12 and 24)
- Change From Baseline in Monthly Acute Migraine-specific Medication Treatment Days(4-week baseline phase and the last 4 weeks of the 12-week treatment phase)
- Change From Baseline in Cumulative Monthly Headache Hours(4-week baseline phase and the last 4 weeks of the 12-week treatment phase)