NCT01772524已完成1 期
A Parallel Group, Double-Blind, Randomized, Placebo Controlled Phase 1b Trial to Evaluate the Safety, Pharmacokinetics, and Efficacy of a Single Dose of ALD403 Administered Intravenously in Patients With Frequent Episodic Migraines
Alder Biopharmaceuticals, Inc.25 个研究点 分布在 1 个国家目标入组 163 人开始时间: 2013年1月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 发起方
- 入组人数
- 163
- 试验地点
- 25
- 主要终点
- Safety of ALD403: laboratory variables, ECG and adverse events
研究概览
简要总结
The purpose of this study is to assess the safety, pharmacokinetics and efficacy of a single dose of ALD403 in the prevention of migraine headache in frequent episodic migraineurs for 24 weeks.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
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
- 未提供
排除标准
- 未提供
研究组 & 干预措施
Saline
Placebo Comparator
Single IV infusion on Day 0
干预措施: Placebo (Drug)
ALD403
Experimental
Single IV Dose on Day 0
干预措施: ALD403 (Biological)
结局指标
主要结局
Safety of ALD403: laboratory variables, ECG and adverse events
时间窗: 24 weeks
* Physical Examination * Vital signs * 12-lead ECG (electrocardiogram) * Clinical laboratory tests (hematology, chemistry) * Number of participants with Adverse Events
次要结局
- Efficacy of ALD403(12 weeks)
- Evaluation of Pharmacokinetics of ALD403(24 weeks)
研究者
研究点 (25)
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