NCT02275117已完成2 期
A Parallel Group, Double-Blind, Randomized, Placebo Controlled, Dose-Ranging Phase 2 Trial to Evaluate the Efficacy, Safety, and Pharmacokinetics of ALD403 Administered Intravenously in Patients With Chronic Migraine
Alder Biopharmaceuticals, Inc.94 个研究点 分布在 2 个国家目标入组 665 人开始时间: 2014年10月1日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 665
- 试验地点
- 94
- 主要终点
- 75% Migraine Responder Rate
研究概览
简要总结
The purpose of this study is to assess ALD403 in the prevention of migraine headache in chronic 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of migraine at ≤ 35 years of age with history of chronic migraine ≥ 1 year
- •During the 28 day screening period, must have ≥ 15 headache days of which ≥ 8 days were assessed as migraine days with at least 5 migraine attacks as recorded in the eDiary
- •Headache eDiary was completed on at least 22 of the 28 days prior to randomization
排除标准
- •Confounding pain syndromes (e.g. fibromyalgia, chronic low back pain, 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-III beta version, 2013), 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
- •Subject has received botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections in the head, face, or neck within 4 months prior to screening.
- •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
结局指标
主要结局
75% Migraine Responder Rate
时间窗: 12 Weeks
Participants with an average reduction in migraine days of at least 75% over Weeks 1 to 12, as compared with baseline.
次要结局
- Change From Baseline in Monthly Migraine Attacks, Weeks 1-12(Weeks 1-12)
- 100% Migraine Responder Rate(Weeks 1-12)
- The Change From Baseline in Monthly Headache Days, Weeks 1-12(Weeks 1-12)
- Percent Change From Baseline in Migraine Days(Weeks 1-12)
- Percent Change From Baseline in Headache Days(Weeks 1-12)
- 50% Migraine Responder Rate(Weeks 1-12)
- 50% Headache Responder Rate(Weeks 1-12)
- 100% Headache Responder Rate(Weeks 1-12)
- The Change From Baseline in Monthly Migraine Days, Weeks 1-12(Weeks 1-12)
- Change From Baseline in Percentage of Severe Migraines(Weeks 1-12)
- Time to First Migraine After Dosing(Baseline to Week 49 (End of Study))
- Change From Baseline to Weeks 9-12 in Percentage of Migraines With Use of Acute Medication(Weeks 9-12)
- Change From Baseline to Weeks 9-12 in Percentage of Headaches With Use of Acute Medication(Weeks 9-12)
- Change From Baseline in Percentage of Severe Headaches(Weeks 9-12)
- The Change From Baseline to Week 12 in HIT-6 Total Score(Baseline to 12)
- Change From Baseline in Monthly Headache Hours, Weeks 1-12(Weeks 1-12)
- Change From Baseline in Monthly Headache Episodes, Weeks 1-12(Weeks 1-12)
- Change From Baseline in Monthly Migraine Hours, Weeks 1-12(Weeks 1-12)
- Baseline and Change From Baseline in Short Form Health Survey (SF-36, Version 2.0) at Week 12(Baseline to Week 12)
研究者
研究点 (94)
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