2022-501100-94-00招募中3 期
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
- 3 期
- 状态
- 招募中
- 入组人数
- 151
- 试验地点
- 37
- 主要终点
- Change from baseline in mean monthly migraine days across the 12-week treatment period.
研究概览
简要总结
To evaluate the safety and efficacy of two doses of atogepant (low and high) when administered daily for the treatment of episodic migraine in pediatric participants 6 to 17 years of age.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Follow-Up Period
- 盲法
- None
入排标准
- 年龄范围
- 0 years 至 17 years（0-17 Years）
- 接受健康志愿者
- 是
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 last 28-day baseline period per eDiary.
- •To be eligible for the PK substudy, participants must be 6 to 11 years of age (inclusive), with a history of migraine and per investigator judgment is appropriate to receive preventive treatment for migraine.
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 daily persistent headache, trigeminal autonomic cephalgia (e.g., cluster headache), or painful cranial neuropathy as defined by ICHD-3 (2018).
结局指标
主要结局
Change from baseline in mean monthly migraine days across the 12-week treatment period.
Change from baseline in mean monthly migraine days across the 12-week treatment period.
次要结局
- Change from baseline in mean monthly headache days across the 12-week treatment period.
- Change from baseline in mean monthly acute medication use days across the 12-week treatment period.
- Achievement of at least a 50% reduction in 3-month average of monthly migraine days.
- Change from baseline in the PedsQL total score at Week 12.
- Change from baseline in the PedMIDAS total score at Week 12.
研究者
Global Clinical Trials Helpdesk
Scientific
Abbvie Deutschland GmbH & Co. KG
研究点 (37)
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