2024-513836-28-00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 Chronic Migraine in Pediatric Subjects 12 to 17 Years of Age
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 95
- 试验地点
- 14
- 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
The primary objective is to evaluate the safety and efficacy of atogepant when administered daily for the preventive treatment of chronic migraine in pediatric subjects 12 to 17 years of age.
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 pounds) and < 135 kg (298 pounds).
- •Subject has a history of migraine with or without aura consistent with a diagnosis according to the International Classification of Headache Disorders, 3rd Edition (ICHD-3) (2018) for at least 6 months as of Visit
- •Current or past use of at least 1 oral medication (over-the-counter medication or prescription medication) for the treatment of migraine.
排除标准
- •Migraine with brainstem aura, hemiplegic migraine, or retinal migraine as defined by ICHD-3 (2018).
- •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.
- Percentage of Participants who Achieve at Least a 50% Reduction in 3-Month Average of Monthly Migraine Days.
- Change from Baseline in the Pediatric Quality of Life Inventory (PedsQL) Total Score at Week 12.
- Change from Baseline on the Pediatric Migraine Disability Assessment (PedMIDAS) Total Score at Week 12.
研究者
Global Clinical Trials Helpdesk
Scientific
AbbVie Deutschland GmbH & Co. KG
研究点 (14)
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