A Phase 2a Randomized Double-blind Placebo Controlled Study to Evaluate the Efficacy and Safety of AMG 301 in Migraine Prevention
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Amgen
- 入组人数
- 343
- 试验地点
- 1
- 主要终点
- Change From Baseline in Monthly Migraine Days to the Last 4 Weeks of the 12 Week Double-Blind Treatment Period
研究概览
简要总结
To evaluate the effect of AMG 301 compared to placebo on the change from the baseline period in monthly migraine days in subjects with migraine.
详细描述
A Phase 2a, randomized, double-blind, placebo-controlled, 3-arm parallel group study to evaluate the efficacy and safety of AMG 301 in subjects with chronic migraine or episodic migraine.
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 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Adults ≥ 18 to ≤ 60 years of age at the time of signing the informed consent form.
- •History of migraine (with or without aura) for ≥ 12 months before screening according to the International Headache Society (IHS) Classification ICHD-III (Headache Classification Committee of the International Headache Society, 2013)
- •Migraine frequency: ≥ 4 migraine days per month on average across the 3 months before screening.
- •Failed at least 1 medication for prophylactic treatment of migraine due to tolerability or lack of efficacy
排除标准
- •Older than 50 years of age at migraine onset.
- •History of cluster headache, hemiplegic migraine headache.
- •Unable to differentiate migraine from other headaches.
- •Migraine with continuous pain, in which the subject does not experience any pain-free periods (of any duration) during the 1 month before the screening period.
- •History or evidence of any other clinically significant disorder, condition or disease that, in the opinion of the investigator or Amgen physician, if consulted, would pose a risk to subject safety or interfere with the study evaluation, procedures or completion.
研究组 & 干预措施
Placebo
Participants randomized to Placebo were administered 6 subcutaneous (SC) injections on day 1 and weeks 2, 4, 6, 8 and 10 during the 12 week double-blind treatment period.
干预措施: Placebo (Drug)
AMG 301 210 mg Q4W
Participants randomized to AMG 301 210 mg every fourth week (Q4W) received a total of 3 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) plus 3 matching placebo injections on day 1 and weeks 4 and 8. Participants also received 6 SC placebo injections on weeks 2, 6, and 10 during the 12 week double-blind treatment period.
干预措施: AMG 301 (Drug)
AMG 301 420 mg Q2W
Participants randomized to AMG 301 420 mg every second week (Q2W) received a total of 6 AMG 301 subcutaneous (SC) injections (70 mg/mL in each injection) on day 1 and weeks 2, 4, 6, 8, and 10 during the 12 week double-blind treatment period.
干预措施: AMG 301 (Drug)
结局指标
主要结局
Change From Baseline in Monthly Migraine Days to the Last 4 Weeks of the 12 Week Double-Blind Treatment Period
时间窗: Baseline Day -28 to Day -1; Weeks 9-12
A migraine day is any calendar day from the eDiary in which the participant experienced a migraine headache. A migraine headache is a headache with or without aura, lasting for \>= 4 hours, and meeting \>=1 of the criteria: 1. \>= 2 pain features (unilateral, throbbing, moderate to severe, exacerbated with exercise/physical activity) 2. \>= 1 symptoms (nausea and/or vomiting, photophobia and phonophobia) If the participant took a migraine-specific medication during aura or to treat headache, it was counted as a migraine day. Days without eDiary data in each monthly interval are handled by proration. Negative change from baseline values indicated improvement (i.e. fewer migraine days after treatment as compared to baseline).
次要结局
- Percentage of Participants Who Responded, Defined as At Least a 50% Reduction From the Baseline Period in Monthly Migraine Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period(Baseline Day -28 to Day -1; Weeks 9-12)
- Change From Baseline Period in Monthly Acute Migraine-Specific Medication Days in the Last 4 Weeks of the 12-Week Double-Blind Treatment Period(Baseline Day -28 to Day -1; Weeks 9-12)
- Change From Baseline in Mean Physical Impairment Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period(Baseline Day -28 to Day -1; Weeks 9-12)
- Change From Baseline in Mean Impact on Everyday Activity Domain Scores as Measured by the Migraine Physical Function Impact Diary (MPFID) Over the Last 4 Weeks of the 12-Week Double-Blind Treatment Period(Baseline Day -28 to Day -1; Weeks 9-12)
- Participants With Treatment-Emergent Adverse Events (TEAEs)(Day 1 up to Week 30 (12 weeks of double-blind treatment plus 18 weeks follow-up after last dose of investigational product))
- Percentage of Participants Who Met Hy's Law Criteria at Baseline and On Study(Baseline: Day 1 On study: Weeks 4, 6, 12, 20, 28)
- Percentage of Participants With Aminotransferase Test Abnormalities > 3 Times the Upper Limit of Normal (ULN) at Baseline and On Study(Baseline: Day 1 On study: Weeks 4, 6, 12, 20, 28)
- Percentage of Participants With Total Bilirubin Test Abnormalities > 2 Times the Upper Limit of Normal (ULN) at Baseline and On Study(Baseline: Day 1 On study: Weeks 4, 6, 12, 20, 28)
- Percentage of Participants With Systolic Blood Pressure (SBP) in Categories by Visit(Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28)
- Percentage of Participants With Diastolic Blood Pressure (DBP) in Categories by Visit(Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28)
- Percentage of Participants With Pulse Rate in Categories by Visit(Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28)
- Percentage of Participants With Temperature in Categories by Visit(Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28)
- Percentage of Participants With Respiratory Rates in Categories by Visit(Day 1, Weeks 2, 4, 6, 8, 10, 12,16, 20, 24, 28)