NCT05076838已完成1 期
An Open-Label, Single-Dose, Pharmacokinetics Study of VALTOCO® With Open-Label Safety Period in Pediatric Subjects With Epilepsy
适应症
干预措施
相关药物
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 35
- 试验地点
- 13
- 主要终点
- Maximum Plasma Concentration (Cmax) of diazepam after intranasal VALTOCO administered to subjects with epilepsy 2 to 5 years of age
研究概览
简要总结
This is a Phase 1/2a, open-label, single-dose, PK study of VALTOCO with open-label safety period in pediatric epilepsy subjects age 2 to 5 years.
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
- 2 Years 至 5 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Subject has a clinical diagnosis of epilepsy and, in the opinion of the Investigator, may need benzodiazepine intervention for seizure control.
- •Subjects having either partial or generalized epilepsy with motor seizures or seizures with clear alteration of awareness, for which rescue medications have been used at least once in the last 3 months or in the opinion of the investigator, may need a benzodiazepine intervention for seizure control 1-2 times every 3 months on average.
排除标准
- •Subjects whose body weight are < 6 kg or > 33 kg.
- •Subject is undergoing intracranial electroencephalogram (EEG) monitoring.
- •In the opinion of the investigator, a history of clinically significant medical history that would jeopardize the safety of the subject or impact the validity of the study results (such as significant gastrointestinal, renal, nasal polyps or any nasal passage abnormality that could interfere with nasal spray administration.
- •Subject has had significant traumatic injury, major surgery or open biopsy within 30 days prior to study screening.
- •Participation in a clinical trial within 30 days prior to the first dose of study drug.
- •Inadequate or difficult venous access that may jeopardize the quality or timing of the PK samples.
研究组 & 干预措施
Valtoco In Pediatric Subjects with Epilepsy
Experimental
5 mg, 10 mg, or 15 mg dose of intranasal VALTOCO will be administered based on the subject's body weight.
干预措施: Diazepam Nasal Spray [Valtoco] (Drug)
结局指标
主要结局
Maximum Plasma Concentration (Cmax) of diazepam after intranasal VALTOCO administered to subjects with epilepsy 2 to 5 years of age
时间窗: 0-6 hours
次要结局
未报告次要终点
研究者
研究点 (13)
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