jRCT2051230212招募中不适用
A Phase 3, Multicenter, 12-Week, Double Blind, Placebo-Controlled Study to Evaluate the Safety and Efficacy of Atogepant for the Preventive Treatment of Episodic Migraine in Pediatric Subjects 6 to 17 years of age
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- AbbVie GK
- 入组人数
- 450
- 主要终点
- -
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized Controlled Trial
- 干预模型
- Parallel Assignment
- 主要目的
- Prevention Purpose
- 盲法
- Double Blind
入排标准
- 年龄范围
- 6age old over 至 17age old under（—）
- 性别
- All
入选标准
- •Weight is >= 20 kg (44 lbs) and < 135 kg (298 lbs).
- •History of episodic migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders (ICHD) -3 (2018) for at least 6 months.
- •Participant has to have 4 to 14 migraine days and < 15 headache days in the 28-day baseline period per eDiary.
排除标准
- •History of migraine brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).
- •Have a current diagnosis of chronic migraine as defined by ICHD-3 (2018).
- •Have a current diagnosis of new persistent daily headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).
- •Have required in-hospital (excluding emergency department visits) treatment for migraine 3 or more times in the 6 months prior to Visit 1.
结局指标
主要结局
-
Change from Baseline in Mean Monthly Migraine Days [ Time Frame: Baseline (Week 0) through Week 12 ]
次要结局
未报告次要终点
研究者
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