NCT02559895已完成3 期
A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines
Alder Biopharmaceuticals, Inc.2 个研究点 分布在 2 个国家目标入组 898 人开始时间: 2015年9月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 898
- 试验地点
- 2
- 主要终点
- Change From Baseline in Monthly Migraine Days (Weeks 1-12)
研究概览
简要总结
The purpose of this study is to assess ALD403 in the prevention of migraine headache in frequent episodic migraineurs.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of migraine at ≤ 50 years of age (ICHD-II, 2004 Section 1)
- •History of migraine ≥ 12 months with
- •≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) in each 28 day period in the 3 months prior to screening
- •During the 28 days following the screening visit, the subject experiences ≤ 14 headache days of which at least 4 have to be migraine days (migraine days count as headache days) as recorded in the eDiary
- •No use of any botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck 4 months prior to screening and during the 28 day period prior to randomization
- •Headache eDiary was completed on at least 25 of the 28 days prior to randomization
排除标准
- •Confounding pain syndromes, e.g. fibromyalgia, complex regional pain syndrome or any pain syndrome that requires regular analgesia
- •Psychiatric conditions that are uncontrolled and untreated, including conditions that are not controlled for a minimum of 6 months prior to screening
- •History or diagnosis of complicated migraine (ICHD- II, 2004 Section 1), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, migraine with brainstem aura, sporadic and familial hemiplegic migraine
- •Unable to differentiate migraine from other headaches
- •Have any clinically significant concurrent medical condition
- •Receipt of any monoclonal antibody treatment within 6 months of screening (within or outside a clinical trial)
- •Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway
研究组 & 干预措施
ALD403 Dose Level 2
Experimental
ALD403 Dose Level 2 (IV)
干预措施: ALD403 (Drug)
ALD403 Dose Level 1
Experimental
ALD403 Dose Level 1 (IV)
干预措施: ALD403 (Drug)
ALD403 Dose Level 3
Experimental
ALD403 Dose Level 3 (IV)
干预措施: ALD403 (Drug)
Placebo
Placebo Comparator
Placebo (IV)
干预措施: Placebo (Drug)
结局指标
主要结局
Change From Baseline in Monthly Migraine Days (Weeks 1-12)
时间窗: Week 1-12
Monthly migraine days are summarized in 28-day intervals, and averaged across Weeks 1-12
次要结局
- 75% Migraine Responder Rate(Week 1-4)
- Percentage of Participants With a Migraine on the Day After Dosing(1 day)
- 50% Headache Responder Rate(Week 1-12)
- 100% Migraine Responder Rate(Week 1-12)
- 100% Headache Responder Rate(Week 1-12)
- Change From Baseline in Average Daily Migraine Prevalence to Week 4(Baseline to Week 4)
- Percent of Headaches With Severe Intensity(Week 1-12)
- Percent of Migraines With Severe Intensity(Week 1-12)
- 50% Migraine Responder Rate(Week 1-12)
- 75% Headache Responder Rate(Week 1-12)
- Change From Baseline in Acute Migraine Medication Days (Weeks 1-12)(Week 1-12)
- Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication(Week 1-12)
- Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication(Week 1-12)
- Change From Baseline in Monthly Headache Days (Weeks 1-12)(Week 1-12)
- Health Related Quality of Life (EQ-5D-5L) at Week 12(Week 12)
- Change From Baseline in Monthly Migraine Hours (Weeks 1-12)(Week 1-12)
- Change From Baseline in Monthly Headache Hours, Weeks 1-12(Week 1-12)
- Change From Baseline of Short Form Health Survey (SF-36 v 2.0) Scale Scores(Baseline to Week 12)
- Change in Baseline of Allodynia Symptom Checklist-12 (ASC-12) Total Score(Baseline to Week 12)
研究者
研究点 (2)
Loading locations...
相似试验
已完成
2 期
A Multicenter Assessment of ALD403 in Chronic MigraineMigraine DisordersNCT02275117Alder Biopharmaceuticals, Inc.665
已完成
3 期
Evaluation of ALD403 (Eptinezumab) in the Prevention of Chronic MigraineMigraine DisordersNCT02974153Alder Biopharmaceuticals, Inc.1,121
已完成
不适用
Study With Migraid Device in Acute, Early Treatment of Migraine With Typical AuraMigraine With Typical AuraNCT00126035Profess Medical Consultancy134
招募中
不适用
Post-marketing Clinical Trial of Elexir(Trigeminal Nerve Electrical Stimulator) for the Acute Treatment of MigraineMigraineNCT06170411Nu Eyne Co., Ltd.100
已完成
3 期
Study of Two Digital Therapeutics for the Prevention of Episodic Migraine Receiving CGRP Therapy (ReMMiD-C)Episodic MigraineHeadacheHeadache, MigraineMigraineNCT06004388Click Therapeutics, Inc.110