A 12-week Double-blind, Randomized, Multi-center Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous AMG 334 Against Placebo in Adult Episodic Migraine Patients (EMPOwER)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 900
- 试验地点
- 80
- 主要终点
- Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP)
研究概览
简要总结
This study is to evaluate the efficacy and safety of AMG334 in adult patients with episodic migraine
详细描述
This study used a single-cohort, 3-treatment arm, randomized, double-blind study design in adult patients with episodic migraine. The subjects were randomized to receive either erenumab or placebo in a 2:3:3 ratio (erenumab 140 mg: erenumab 70 mg: placebo). A screening period of 2 weeks was used to assess initial eligibility, followed by a 4-week baseline period. After randomization/Day 1, visits occurred at four week intervals until Week 12, which was the End of Treatment. The final visit, Last Patient Last Visit was a Safety Follow-Up visit, which occurred 12 weeks later, at Week 24.
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
- 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
- •Documented history of migraine in the 12 months prior to screening
- •4-14 days per month of migraine symptoms
- •>=80% diary compliance during the Baseline period
排除标准
- •>50 years old at migraine onset
- •Pregnant or nursing
- •History of cluster or hemiplegic headache
- •Evidence of seizure or major psychiatric disorder
- •Score of 19 or higher on the BDI
- •Active chronic pain syndrome
- •Cardiac or hepatic disease
研究组 & 干预措施
Placebo
Two pre-filled syringes containing placebo identical in appearance to erenumab
干预措施: Placebo (Other)
AMG334 140 mg
AMG334 140 mg: two pre-filled syringe containing 70 mg each of erenumab administered subcutaneous every 28 days
干预措施: Erenumab (Biological)
AMG334 70 mg
AMG334 70 mg: one pre-filled syringe containing 70 mg of erenumab plus one pre-filled syringe of identical placebo administered subcutaneous every 28 days
干预措施: Erenumab (Biological)
结局指标
主要结局
Change From Baseline in Monthly Migraine Days at the Last Month (Month 3) of the Double-blind Treatment Period (DBTP)
时间窗: Baseline up to Month 3
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as a migraine with or without aura, lasting for ≥ 30 minutes, and meeting at least one of the following criteria: 1. ≥ 2 of the following pain features: unilateral, throbbing, moderate to severe or 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 Acute Migraine-specific Medication Treatment Days at Month 3(Baseline up to Month 3)
- Change From Baseline in Headache Impact Scores as Measured by the Headache Impact Test (HIT-6) at Month 3(Baseline up to Month 3)
- Percentage of Participants With at Least a 50% Reduction From Baseline in Monthly Migraine Days at Month 3(Baseline and at Month 3)