A 12-week Phase 3, Randomized, Double-blind, Placebo Controlled Study to Evaluate the Efficacy and Safety of Once Monthly Subcutaneous Erenumab 70 mg in Adult Chronic Migraine Patients
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 557
- 试验地点
- 1
- 主要终点
- Change From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period
研究概览
简要总结
The purpose of this study was to evaluate the efficacy and safety of erenumab in patients with chronic migraine in Asian population.
详细描述
This study used a single-cohort, 2-treatment arms, randomized (1:1 (70 mg:placebo)), double-blind study design in adult subjects with chronic migraine. A screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period to assess diary compliance and headache frequency.
Eligible patients were then randomized to either erenumab 70 mg or placebo for 12 weeks, followed by an open-label treatment period to last until end of PTA determined by the product launch in the country or the country's decision not to launch. A safety follow-up visit occurred 12 weeks after the last treatment for subjects who discontinue the double-blind treatment or who completed the double-blind treatment period without continuing in the open-label treatment period.
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
- Triple (Participant, Care Provider, Investigator)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Erenumab
Administered by pre-filled syringe
干预措施: Erenumab (Biological)
Placebo
Administered by pre-filled syringe
干预措施: Placebo (Other)
结局指标
主要结局
Change From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period
时间窗: baseline (4 weeks period prior to start of study drug), week 9 to 12
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache (onset, continuation, or recurrence of the migraine headache). A qualified migraine headache was defined as a migraine with or without aura, lasting for ≥4 continuous hours, and meeting at least one of the following criteria: 1. ≥2 of the following pain features: * Unilateral * Throbbing * Moderate to severe * Exacerbated with exercise/physical activity 2. ≥1 of the following associated symptoms: * Nausea and/or vomiting * Photophobia and phonophobia
次要结局
- Change From Baseline in Migraine-related Disability and Productivity as Measured by the mMIDAS During the Last 4 Weeks of the 12-week Treatment Period(baseline (4 weeks period prior to start of study drug), week 9 to 12)
- Number of Participants With at Least 50% Reduction From Baseline in Monthly Migraine Days During the Last 4 Weeks of the 12-week Treatment Period(baseline (4 weeks period prior to start of study drug), week 9 to 12)
- Change From Baseline in Monthly Acute Headache Medication Days During the Last 4 Weeks of the 12-week Treatment Period(baseline (4 weeks period prior to start of study drug), week 9 to 12)
- Number of Subjects With Adverse Events as a Measure of Safety(DBTP: 12 weeks for participants entering the OLTP. 20 weeks for participants NOT entering the OLTP. OLTP: From week 12 until up to approximately 4 years.)
- Number of Subjects With Anti-AMG 334 Antibodies(baseline, 20 weeks)