Melatonin for the Treatment of Developmental/Epileptic Encephalopathy With Spike Wave Activation In Sleep (DEE-SWAS; Formerly ESES)
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 3
- 主要终点
- Adverse Events
研究概览
简要总结
The goal of this study is to learn if melatonin, a naturally produced substance, can help to treat some of the symptoms of DEE-SWAS, a type of epilepsy that causes children to lose skills and development. It will look at doses of melatonin that are higher than most people use.
The study will look at the safety of melatonin in patients with DEE-SWAS The study will look at the ways melatonin affects abnormal brain activity on a study called an EEG.
The study will look at the ways melatonin affects normal brain activity that occurs in sleep.
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
入排标准
- 年龄范围
- 5 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Clinic Dx of DEE-SWAS
- •Dx of DEE-SWAS by a board-certified pediatric neurology/epileptologist Clinical history of delayed milestones in at least 1 category, regression of milestones in at least 1 category, and/or failure to progress in milestones in at least 1 category
- •Abnormal baseline neuropsychiatric testing consistent with Dx Abnormal EEG
- •Epileptiform abnormalities (spike, polyspike, sharp) in at least 1 head region
- •Increase by 2-fold of epileptiform abnormalities during NREM sleep as compared to wakefulness
- •SWI of ≥50% in at least one head region on overnight EEG
排除标准
- •Allergic to ingredients in study drug Melatonin
- •Hypoallergenic plant fiber (cellulose)
- •Active use of the medication viloxazine
- •History of known cardiac rhythm abnormalities, heart failure or decreased EF <30%
- •History of known pulm requiring oxygen or invasive positive pressure ventilation. Patients with non-invasive PPV (e.g. CPAP) due OSA w/o 02 requirement, rate, or DX of CSA, on stable pressure settings for >3 mnths will not be excluded.
- •History of liver dysf OR AST/ALT/AlkPhos >2.5 ULN w/i year. If lab value meeting exclusion between 3-12 months, a repeat lab value < 2.5 ULN will be considered for inclusion
- •Post-menarchal participants. of childbearing potential with a positive urine pregnancy test
研究组 & 干预措施
Melatonin
Melatonin 0.3mg/kg (20mg max)
干预措施: Melatonin (Drug)
结局指标
主要结局
Adverse Events
时间窗: Within 24 hours of dose administration
This study will evaluate for adverse events associated with single high dose melatonin administration
Side effects
时间窗: Within 24 hours of dose administration
This study will evaluate for multiorgan adverse effects associated with single high dose melatonin administration based on standardized questionnaire assessment. The assessment is a multiorgan adverse event questionnaire described in Jarernsiripornkul 2001, modified to reflect single dosing rather than chronic dosing. The results of this questionanaire are descriptive.
次要结局
- Spike wave index (SWI)(Within 24 hours of dose administration)
- Sleep spindle(Within 24 hours of dose administration)
- Salivary melatonin pharmacokinetics(24 hours prior to intervention and 24 hours following intervention)
研究者
Carosella, Christopher
Assistant Professor of Neurology
Hugo W. Moser Research Institute at Kennedy Krieger, Inc.