An Open Label Benzodiazepine Study for the Treatment of Seizure Clusters in a Third Level Mexican Neurological Center
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 150
- 试验地点
- 1
- 主要终点
- Change from baseline seizure frequency comparison using buccal midazolam, orodispersable clonazepam versus usual care efficacy for seizure clusters
研究概览
简要总结
The aim of this study is to determine the efficacy in seizure reduction when comparing orodispersable clonazepam versus usual treatment (i.e. medication load, intravenous high- dose benzodiazepines) of seizure clusters in a third level center of care in Mexico city.
详细描述
This is an open label, randomized, prospective clinical trial, with a 1:1:1 aleatorization of a single third level specialized neurological center.
Primary objective: To evaluate the clinical impact of the use of buccal midazolam as a treatment of seizure clusters in comparison with orodispersable clonazepam vs usual care.
Secondary objective: To identify patients that present seizure clusters and risk factors associated with the diagnosis. To evaluate the quality of life after drug administration, to evaluate the adverse events associated with the medications. To establish seizure recurrence and mortality in 6 months' follow up.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •At least age of 18
- •Patient available for follow-up
- •Previous diagnosis of epilepsy
- •Patient meets criteria for seizure clusters (3 or more seizures in a period of 24 hours)
排除标准
- •Risk factors for epilepsy have been identified and uncontrolled.
- •Younger than 18 years olf
- •Follow- up in another healthcare unit
- •No previous epilepsy diagnosis
- •Adequate control of epilepsy
- •Patient meets criteria for clinical or electrographic status epilepticus.
研究组 & 干预措施
Orodispersable clonazepam
50 patients will receive oral orodispersable clonazepam.
干预措施: ClonazePAM Oral Product (Drug)
Buccal midazolam
50 patients will receive buccal midazolam.
干预措施: Midazolam oral solution (Drug)
Conventional treatment
50 patients will receive "usual/ conventional treatment of seizure clusters"
干预措施: Usual medication/ traditional (Other)
结局指标
主要结局
Change from baseline seizure frequency comparison using buccal midazolam, orodispersable clonazepam versus usual care efficacy for seizure clusters
时间窗: 1,3 and 6 months
Seizure frequency description, using the Engel Score of Seizure Outcomes
次要结局
- Change from baseline seizure recurrence in 6 months(6 months)
- Change from baseline quality of life assessed by the QOLIE-31 from baseline(6 months)
研究者
Elma Paredes-Aragón
Staff Neurologist, Epileptologist
El Instituto Nacional de Neurologia y Neurocirugia Manuel Velasco Suarez