NCT07594652招募中4 期
Use of JornayPM® to Treat ADHD in Pediatric Epilepsy
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.1 个研究点 分布在 1 个国家目标入组 25 人开始时间: 2026年5月29日最近更新:
干预措施
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 入组人数
- 25
- 试验地点
- 1
研究概览
简要总结
This is an observational study assessing the usage of stimulant medication for ADHD in the context of pediatric epilepsy.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
盲法说明
open label, flexible dose
入排标准
- 年龄范围
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Inclusion criteria:
- •Established diagnosis of epilepsy that requires treatment with anti-seizure medication.
- •No episodes of seizure clusters or status epilepticus within 30 days prior to entry into the study.
- •Diagnosis of ADHD with functional impairment.
- •Good general health as determined by medical history and physical examination, including stable vital signs.
- •Participant or legal caregiver capable of providing informed consent and fully capable of monitoring the subject's disease process and compliance with treatment.
排除标准
- •• Previous allergic or hypersensitivity reactions to stimulant medicines including Jornay PM®
- •Active substance abuse or dependence within 30 days of enrollment
- •Epilepsy that is unstable or with seizure frequency that exceeds four events per month, based on an average over the previous three months
- •DSM-V diagnosis of psychotic illness or imminent risk of harm to self or others.
- •Current use of stimulants to treat ADHD
- •Serious or unstable medical or neurologic conditions such as HIV, liver or kidney disease, cancer or diabetes.
- •Unstable cardiac illness such as arrythmias or cardiomyopathy.
- •Participation in a previous experimental drug study within 30 days of baseline visit.
- •Estimated IQ<70 as indicated by clinical assessment to the degree that rating scales may be invalid
- •Insufficient capacity of caregiver or legal guardian to understand and appropriately consent for study procedures
研究组 & 干预措施
interventional arm
Experimental
open label flexible dose
干预措施: methylphenidate hydrochloride (Jornay PM) (Drug)
研究者
Jay Salpekar, M.D.
Principal Investigator
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.
研究点 (1)
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