NCT03371836已完成4 期
Use of Clobazam in Treating Anxiety Comorbid With 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 20 人开始时间: 2017年10月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 入组人数
- 20
- 试验地点
- 1
- 主要终点
- CGI-I
研究概览
简要总结
This study is an open label, adjunctive, proof of concept, pilot clinical trial. Pediatric patients with epilepsy and clinically significant anxiety will be recruited and if enrolled will receive active treatment, involving flexible dose titration of clobazam and will be monitored for a period of four months. The study will be monitored and overseen by the Johns Hopkins Hospital Institutional Review Board.
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
- 6 Years 至 17 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Established diagnosis of epilepsy, characterized by focal seizures with suspected or documented localization in the temporal lobe. All participants will have active epilepsy that requires treatment with anticonvulsant medication.
- •Although it is not necessary to be seizure free, a seizure baseline period will be established in the 60 days prior to enrollment into the study.
- •Current regimen of anticonvulsant drugs must have been stable for 30 days prior to entry into the study.
- •No episodes of seizure clusters of status epilepticus within 30 days prior to entry into the study.
- •Established symptoms of anxiety with functional impairment.
- •A diagnosis of an anxiety disorder based on the administration of the K-SADS Male or female participants equal to or above age 6 and below age 18 at the start of the study. No exclusion will be made on the basis of gender or minority status.
- •Male or female participants equal to or above age 6 and below age 18 at the start of the study. No exclusion will be made on the basis of gender or minority status.
- •Good general health as determined by medical history and physical examination.
- •Ability to swallow pills (participant will receive pill swallowing instruction if necessary). The medicine may be cut into pieces and/or mixed with applesauce.
- •If female of childbearing age, a negative urine or serum pregnancy test must be established or assured at baseline. Additionally, the participant must agree to use abstinence or appropriate contraception methods or be otherwise incapable of pregnancy for the duration of the study. Pregnancy test results will be shared with parent or guardian. Pregnancy status (or prevention) and abstinence or contraception methods will be addressed throughout the study for females of childbearing age as well as for post-pubertal males.
- •Previous subjects who failed at any point to meet continuation criteria and withdrew early may be considered for re-enrollment by the PI on a case-by-case basis.
- •Participant or legal caregiver capable of providing informed consent and fully capable of monitoring the subject's disease process and compliance with treatment.
- •Exclusion criteria:
- •Previous allergic or hypersensitivity reactions to Onfi® or benzodiazepines
- •Active substance abuse or dependence within 30 days of enrollment
- •DSM-V diagnosis of psychotic illness or imminent risk of harm to self or others.
- •Current standing use of benzodiazepines (except as "rescue" medicine)
- •Serious or unstable medical or neurologic conditions such as HIV, liver or kidney disease, cancer or diabetes.
- •Participation in a previous experimental drug study within 30 days of baseline visit.
- •Estimated IQ<70 as indicated by initial clinical assessment (rendering rating scales invalid)
- •Insufficient capacity of caregiver or legal guardian to understand and appropriately consent for study procedures
排除标准
- 未提供
研究组 & 干预措施
Clobazam
Other
open label (single treatment arm)
干预措施: Clobazam (Drug)
结局指标
主要结局
CGI-I
时间窗: 14-18 weeks
Mean of Clinical Global Impression-Improvement from baseline. (1-7 point scale; lower score equals a better outcome; 1 is the maximum improvement, 7 is the minimum improvement)
次要结局
未报告次要终点
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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