Efficacy of IV Brivaracetam compared to IV Levetiracetam in seizure cluster: A Randomized prospective single blinded parallel group pilot study
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of patients with no clinical seizure recurrence by 24 hours post-loading dose. This 24-hour timepoint is the main efficacy assessment
研究概览
简要总结
In this study patients presenting with seizure cluster will be randomized to two treatment groups A and B, group A receive intravenous brivaracetam and group B receive intravenous levetiracetam and both groups will be assessed for non-recurrence of clinical seizures over next 24 hours. Secondary outcomes like time to recurrence of clinical seizure between both groups, proportion of patients requiring rescue antiseizure medications following initial treatment, to compare adverse event profiles, differences in post-treatment neurological recovery at discharge, to evaluate the need for ICU admission and overall length of hospital stay will be assessed. This study is aimed at evaluating the efficacy of intravenous brivaracetam and intravenous levetiracetam in patients presenting with seizure cluster.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting with cluster seizures.
排除标准
- •Post cardiac arrest seizures
- •Pregnant females
- •Lactating females
- •Major trauma
- •Known allergy to either drug
- •Patients already on brivaracetam and levetiracetam within last 1 month
- •Patients requiring immediate neurosurgical intervention
- •Patients who were brought intubated or had to be intubated in emergency services
- •Severe hemodynamic compromise (SBP less than 100mmhg)
- •Serious arrythmias (eg: heart rate less than 50/min, second or third degree heart blocks, runs of ventricular ectopics)
- •Patients in cardiac failure, pulmonary edema.
结局指标
主要结局
Proportion of patients with no clinical seizure recurrence by 24 hours post-loading dose. This 24-hour timepoint is the main efficacy assessment
时间窗: In addition to the 24 h endpoint, patients will have brief assessments at 1 hour and, optionally, at 6 and 12 hours if indicated by clinical status
次要结局
- 1. To compare the time to clinical seizure recurrence between the brivaracetam & levetiracetam groups.(2. To assess the proportion of patients requiring rescue antiseizure medications following initial treatment.)
研究者
Manjari Tripathi
AIIMS, DELHI, INDIA