Non-inferiority Prospective Randomized Trial of Acetazolamide Versus Diazepam in Patients With Continuous Spike and Wave in Sleep (CSWS)/Landau Kleffner Syndrome (LKS)
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Mayo Clinic
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Short-term Tolerability of Acetazolamide vs Diazepam
研究概览
简要总结
The purpose of this study is to compare the effectiveness of the medications acetazolamide and diazepam in the treatment of continuous spike wave in sleep (CSWS) and Landau-Kleffner syndrome (LKS).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 3 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •ESES and clinical CSWS/LKS defined by all of the following:
- •SWI ≥50% during first hour of sleep
- •Bilateral synchrony of discharges during sleep
- •Clinical evidence of behavior and/or academic regression
- •Daytime SWI ≤20%
排除标准
- •Previous treatment with benzodiazepine or acetazolamide for Electrical Status Epilepticus in Sleep (ESES)
- •Current treatment with carbamazepine, phenytoin, oxcarbazepine, phenobarbital, vigabatrin or lamotrigine
- •Antiepileptic medication changes over the month prior to enrollment
- •Epileptic encephalopathy other than CSWS/LKS
- •Prior serious adverse reaction to benzodiazepines or acetazolamide
- •Sulfa allergy
- •Progressive underlying neurologic condition
- •Frequent seizures that would prevent the patient from maintaining a stable dose of medications
- •Female patient that has begun menses or is pregnant
研究组 & 干预措施
Diazepam
Diazepam 0.5 mg/kg (up to maximum 20 mg) by mouth nightly. Duration of therapy is 4 weeks.
干预措施: Diazepam (Drug)
Acetazolamide
Acetazolamide 8-10 mg/kg (up to a maximum dose of 375 mg) by mouth (PO)divided twice daily X 1 week, then increased to 11-16 mg/kg (up to a maximum dose of 750 mg) by mouth divided twice daily thereafter. Duration of therapy is 4-8 weeks.
干预措施: Acetazolamide (Drug)
结局指标
主要结局
Short-term Tolerability of Acetazolamide vs Diazepam
时间窗: 4-8 weeks of start of medications
Expect improved side effect profile of acetazolamide compared to diazepam at short-term follow up
次要结局
未报告次要终点