A 12-week Double-blind, Randomized, Multicenter Study Comparing the Efficacy and Safety of Once Monthly Subcutaneous 140 mg AMG 334 Against Placebo in Adult Episodic Migraine Patients Who Have Failed 2-4 Prophylactic Treatments (LIBERTY)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 246
- 试验地点
- 60
- 主要终点
- Percentage of Participants With at Least 50% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
研究概览
简要总结
The purpose of this study is to determine if AMG 334 is effective in treating migraines in patients who have failed other preventive migraine treatments.
详细描述
This study was a double blind, placebo-controlled, randomized trial in adult patients with episodic migraine. There was a screening period of 2 weeks to assess initial eligibility, and a 4-week baseline period. After randomization, participants entered the double-blind treatment epoch (DBTE) and had clinic visits for 12 weeks. All participants who completed the DBTE were eligible to enter the Open-Label Treatment Epoch (OLTE) for up to 156 weeks. All participants had a 12 week Follow-Up Epoch and a a Follow-Up visit 16 weeks after the last dose of AMG334 unless the participant continued on commercially available AMG334. Participants who had demonstrated clinical benefit were eligible to enter a Post Trial Access (PTA-Open Label Treatment Epoch) of flexible duration for approximately 6 months.
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
- Double (Participant, 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
- •Documented history of migraine in the 12 months prior to screen
- •4-14 days per month of migraine symptoms
- •>=80% diary compliance during the Baseline period
- •Failure of previous migraine prophylactic treatments
排除标准
- •>50 years old at migraine onset
- •Pregnant or nursing
- •History of cluster or hemiplegic headache
- •Evidence of seizure or psychiatric disorder
- •Score of over 19 on Beck Depression Inventory-2
- •Active chronic pain syndrome
- •Cardiac or hepatic disease
结局指标
主要结局
Percentage of Participants With at Least 50% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)
时间窗: Baseline, Month 3 (last 4 weeks of treatment)
A migraine day was defined as any calendar day in which the subject experienced a qualified migraine headache defined as: with/without aura, lasting ≥ 30 minutes with at least 1 criteria: 1. ≥ 2 of following pain features: unilateral, throbbing, moderate to severe or exacerbated with exercise/physical activity, 2. ≥ 1 of the following symptoms: nausea and/or vomiting, photophobia and phonophobia. If a migraine-specific medication (ie, triptan or ergotamine) was taken during aura, or a headache, it was counted as a migraine day regardless of duration and pain features/associated symptoms.
次要结局
- Change From Baseline in Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)(Baseline, Month 3 (last 4 weeks of treatment))
- Percentage of Participants With a 75% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)(Baseline, Month 3 (last 4 weeks of treatment))
- Change From Baseline in Physical Impairment and Everyday Activities as Measured by the Migraine Physical Function Impact Diary (MPFID) at Month 3(Baseline, Month 3 (last 4 weeks of treatment))
- Change in the Number of Monthly Acute Migraine-specific Medication Treatment Days at Month 3(Baseline, Month 3 (last 4 weeks of treatment))
- Percentage of Participants With a 100% Reduction From Baseline of Monthly Migraine Days (MMD) in the Last Month (Last 4 Weeks of Treatment)(Baseline, Month 3 (last 4 weeks of treatment))
- Number of Participants Who Developed Anti-AMG334 Antibodies(Baseline up to approximately 180 weeks)