NCT04748601招募中4 期
A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Phase 4 Study to Evaluate the Efficacy and Safety of Qudexy(R) XR in the Prevention of Migraine in Children 6 to 11 Years of Age
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 132
- 试验地点
- 15
- 主要终点
- Change from Baseline (last 28 days Run-In Period) in the monthly number of headache days during the 8-week Maintenance Period based on the diary.
研究概览
简要总结
A Phase 4 study to evaluate Qudexy XR for the prevention of migraine in children 6 to 11 years of age.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject is a female or male 6 to 11 years of age, inclusive, at Visit 1 (Screening)
- •Subject weighs at least 17.0 kg and less than 50.0 kg at Visit 1 (Screening) based on 95 percentile weight for the age range.11
- •Subject has at least a 6-month history of headaches consistent with a diagnosis of migraine with or without aura (International Classification of Headache Disorders, 3rd Edition [ICHD 3]).
- •Subject had ≥8 self-reported headache days in the 28 days prior to Screening.
- •Subject has a PedMIDAS score >10, indicating at least mild disruption in daily activities, and <140, indicating extreme disability that may require more comprehensive, multi component therapy.
排除标准
- •Subject has continuous migraines, defined as an unrelenting headache for a 28-day period.
- •Subject is currently receiving treatment or has used Botulinum toxin (Botox®) within 3 months prior to Visit 1 (Screening).
- •Subject is currently receiving migraine prevention medication and has initiated or changed the dose within 28 days of Screening or is unwilling to avoid making a change during the duration of the study.
- •Subject has previously failed an adequate trial of topiramate (at least 3 months duration at a clinically appropriate dose) for prophylaxis of migraine headache due to lack of efficacy or AEs.
- •Subject has previously failed an adequate trial of >3 migraine preventative medications.
- •Subject has a known history of allergic reaction to topiramate or any excipient in Qudexy XR.
- •Subject has a diagnosis or history of disease that may interfere with safety or evaluation of the study drug.
- •Subject is currently using an investigational drug or device or has used such within 30 days prior to Visit
- •Subject has begun menses and any of the following:
- •Subject has tested positive for pregnancy; OR
- •Subject is pregnant, planning pregnancy, or lactating; OR
- •Subject is taking an oral hormonal contraceptive (either combined [estrogen and progestogen containing] or progestogen-only) and is unable or unwilling to switch to an alternative highly effective contraceptive method.
研究组 & 干预措施
Placebo
Placebo Comparator
干预措施: Placebo (Drug)
Qudexy XR
Experimental
干预措施: Qudexy XR (Drug)
结局指标
主要结局
Change from Baseline (last 28 days Run-In Period) in the monthly number of headache days during the 8-week Maintenance Period based on the diary.
时间窗: 16 Weeks
次要结局
未报告次要终点
研究者
研究点 (15)
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