A Novel Approach to Infantile Spasms: Combined Cosyntropin Injectable Suspension, 1 mg/mL and Vigabatrin Induction Therapy
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 394
- 试验地点
- 14
- 主要终点
- A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b).
研究概览
简要总结
This study proposes to assess the efficacy of Cosyntropin Injectable Suspension, 1 mg/mL compared to vigabatrin. Additionally, this study proposes to determine efficacy of combination therapy of Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin to monotherapy Cosyntropin Injectable Suspension, 1mg/mL in children with new onset infantile spasms (IS).
详细描述
This is a prospective randomized trial comparing 3 treatment arms:
- Cosyntropin Injectable Suspension, 1 mg/mL
- Vigabatrin
- Combination of both these therapies, Cosyntropin Injectable Suspension, 1 mg/mL and vigabatrin for treatment of new onset infantile spasms. Outcome measures include resolution of clinical spasms, improvement of hypsarrhythmia as well as longer term outcomes of development and subsequent seizures.
The data is expected to demonstrate greater efficacy with Cosyntropin Injectable Suspension, 1 mg/mL than vigabatrin for the treatment of IS.
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
盲法说明
Blinded outcome measure
入排标准
- 年龄范围
- 2 Months 至 2 Years（Child）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •New onset infantile spasms
- •Age > 2 months
- •Age< 2 years
- •Hypsarrhythmia on video-EEG
- •Normal renal function
排除标准
- •Prior treatment given for infantile spasms
- •Diagnosis of Ohtahara syndrome or Early Myoclonic Epilepsy
- •Absence of hypsarrhythmia
- •Inability for the parent or caregiver to provide consent
- •Inability for the parent or caregiver to complete seizure diary
- •Diagnosis of:
- •scleroderma,
- •osteoporosis,
- •recent systemic fungal infections,
- •ocular herpes simplex,
- •recent surgery,
- •history of or the presence of a peptic ulcer,
- •congestive heart failure,
- •uncontrolled hypertension
研究组 & 干预措施
Cosyntropin Injectable Suspension, 1mg/mL + vigabatrin
干预措施: Cosyntropin Injectable Suspension 1 MG/ML + vigabatrin (Drug)
Cosyntropin Injectable Suspension, 1 mg/mL
干预措施: Cosyntropin Injectable Suspension, 1 mg/mL (Drug)
Vigabatrin
干预措施: Vigabatrin (Drug)
结局指标
主要结局
A comparison of Cosyntropin Injectable Suspension and Vigabatrin on the proportion of subjects who become spasm-free as defined by a) and b).
时间窗: 2 weeks
a) Resolution of hypsarrhythmia via video electroencephalogram (EEG), and b) Resolution of clinical spasms via video EEG.
次要结局
- A comparison of combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become spasm-free as defined by a) and b)(Day 14-42)
- Comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy).(18 months chronological age)
- A comparison between combination therapy and Cosyntropin Injectable Suspension alone (monotherapy) on the proportion of subjects who become seizure free at 6 months.(6 months)