NCT02945527终止2 期
Open Controled Randomized Pilot Study on the Use of Acetazolamide and Dexamethasone for the Acute Phase of Perilesional Edema in Calcified Neurocysticercosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 4
- 试验地点
- 1
- 主要终点
- Decrease in Volume of Perilesional Edema Between Baseline and Day 4
研究概览
简要总结
Three-arm open, randomized comparative study of acetazolamide, dexamethasone, or no additional treatment to evaluate decrease in peri-calcification edema in neurocysticercosis
详细描述
This study will evaluate 24 patients with calcified NCC and edema in three treatment arms to compare the reduction in edema volume
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
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Calcified NCC
- •Perilesional edema on CT or MRI
- •Normal lab values
排除标准
- •Viable neurocysticercosis
- •Status epilepticus
- •Symptomatic intracranial hypertension
- •Tuberculosis
- •More than 7 days after seizure
- •Pregnancy
研究组 & 干预措施
Acetazolamide
Active Comparator
750 mg acetazolamide p.o. divided in three dily doses, for 10 days
干预措施: Acetazolamide (Drug)
Dexamethasone
Active Comparator
8 mg p.o. divided in three daily daily doses, for 2 days followed by gradual tapering
干预措施: Dexamethasone (Drug)
结局指标
主要结局
Decrease in Volume of Perilesional Edema Between Baseline and Day 4
时间窗: Baseline to Day 4
MRI extension of edema
次要结局
- Decrease in Volume of Perilesional Edema Between Baseline and Day 8(Baseline to Day 8)
- Decrease in Volume of Perilesional Edema Between Baseline and Day 30(Baseline to Day 30)
研究者
研究点 (1)
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