NCT02161185终止3 期
An Open-Label Safety Study of USL261 in the Outpatient Treatment of Adolescent and Adult Subjects With Seizure Clusters
UCB Biopharma S.P.R.L.0 个研究点目标入组 7 人开始时间: 2014年5月最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 主要终点
- Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation
研究概览
简要总结
The purpose of this study is to examine the long-term safety and tolerability of USL261 in the treatment of seizure clusters.
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
- 12 Years 至 65 Years（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Has a competent, adult caregiver(s) who is able to recognize and observe the subject's seizure cluster episodes
- •Has an established diagnosis of partial or generalized epilepsy that includes all the following:
- •A documented history of seizure clusters lasting a minimum of 10 minutes, seizure cluster pattern is observable, stereotyped, and recognizably different from the subject's other non-cluster seizure activity (if any)
- •A second seizure in the seizure cluster typically occurs within 6 hours from the time of recognition
- •A seizure cluster pattern composed of multiple (≥ 2) partial or generalized seizures
- •A seizure cluster pattern established >3 months before Visit 1
- •A frequency of ≥ 3 stereotyped seizure clusters during the year before Visit 1
- •At least 1 stereotyped seizure cluster occuring ≤ 4 months before Visit 1
- •Currently on a stable regimen of AED(s) that includes a benzodiazepine
- •Weight is 40 kg to 125 kg, inclusive
排除标准
- •Has a neurological disorder that is likely to progress in the next year
- •Has a severe chronic cardio-respiratory disease
- •Has a psychogenic, non-epileptic seizure(s) within the 5 years before Visit 1
- •Has a history of their stereotypical seizure cluster progressing to status epilepticus within 2 years before Visit 1
- •Has a history of acute narrow-angle glaucoma
- •Has had active suicidal plan/intent or active suicidal thoughts in the 6 months before Visit 1 or a suicide attempt in the past 5 years
研究组 & 干预措施
USL261
Other
干预措施: USL261 (Drug)
结局指标
主要结局
Number of Participants With Death, Serious Adverse Events, Treatment Emergent Adverse Events (TEAEs) Leading to Discontinuation
时间窗: Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.
Number of Participants with Death, Serious Adverse Events, Treatment emergent adverse events (TEAEs) leading to subject discontinuation from study
次要结局
- Treatment Success(Duration of individual subject participation was open-ended. Study ended early. Longest subject participation approximately 6 months.)
研究者
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终止
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