NCT02974153已完成3 期
A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 3 Trial to Evaluate the Efficacy and Safety of ALD403 Administered Intravenously in Patients With Chronic Migraine
Alder Biopharmaceuticals, Inc.145 个研究点 分布在 2 个国家目标入组 1,121 人开始时间: 2016年11月1日最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 1,121
- 试验地点
- 145
- 主要终点
- Change From Baseline in Monthly Migraine Days
研究概览
简要总结
The purpose of this study is to assess the efficacy and safety of 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
- 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
- •Males and females between 18 and 65 years of age, inclusive, who were diagnosed with migraines at ≤ 50 years of age, and have a history of chronic migraine for ≥ 12 months before screening.
- •During the 28 day screening period, subjects must adequately complete the headache eDiary and must have headaches occurring on ≥ 15 to ≤ 26 days of which at least 8 must be migraine days.
- •Headache eDiary was completed on at least 24 of the 28 days prior to randomization.
排除标准
- •Confounding and clinically significant pain syndromes (e.g. fibromyalgia, chronic low back pain, complex regional pain syndrome).
- •Psychiatric conditions that are uncontrolled and/or untreated, including conditions that are not controlled for a minimum of 6 months prior to screening. Patients with a lifetime history of psychosis, mania, or dementia are excluded.
- •Any use of botulinum toxin for migraine or for any other medical/cosmetic reasons requiring injections within 4 months prior to screening and during the screening period.
- •History or diagnosis of complicated migraine (ICHD-III beta version, 20134), chronic tension-type headache, hypnic headache, cluster headache, hemicrania continua, new daily persistent headache, or sporadic and familial hemiplegic migraine.
- •Receipt of any monoclonal antibody treatment (within or outside a clinical trial) within 6 months before screening.
- •Previously dosed with ALD403 or any monoclonal antibody targeting the CGRP pathway.
结局指标
主要结局
Change From Baseline in Monthly Migraine Days
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
- Percentage of Participants With a Migraine on the Day After Dosing(Day 1)
- Change in Monthly Acute Medication Days(Week 1-12)
- 75% Headache Responder Rate(Week 1-12)
- Time to First Migraine After Dosing(32 weeks)
- 75% Migraine Responder Rate(Week 1-12)
- 75% Migraine Responder Rate - 4 Week(Week 1-4)
- 50% Migraine Responder Rate(Week 1-12)
- 50% Headache Responder Rate(Week 1-12)
- Change From Baseline in Monthly Headache Days (Weeks 1-12)(Week 1-12)
- Change From Baseline in Monthly Migraine Hours, Weeks 1-12(Week 1-12)
- Duration of Migraine-Free Intervals(32 weeks)
- Change From Baseline of Headache Impact Test (HIT-6) Score(Baseline to Week 12)
- Change in Migraine Prevalence From Baseline to Week 4(Baseline to Week 4)
- 100% Migraine Responder Rate(Week 1-12)
- 100% Headache Responder Rate(Week 1-12)
- Change From Baseline in Monthly Migraine Days (Weeks 13-24)(Week 13-24)
- Change From Baseline to Week 12 in Percentage of Migraines With Use of Acute Medication(Week 1-12)
- Percent Change in Frequency of Migraine Days - Week 1-12(Week 1-12)
- Patient Global Impression of Change (PGIC) at Week 12(Week 12)
- Change From Baseline to Week 12 in Percentage of Headaches With Use of Acute Medication(Week 1-12)
- Percent Change in Frequency of Headache Days - Week 1-12(Week 1-12)
- Change From Baseline in Percentage of Severe Headache(Week 1-12)
- Change From Baseline in Percentage of Severe Migraines(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)
- Health Related Quality of Life (EQ-5D-5L) at Week 12(Week 12)
研究者
研究点 (145)
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