Use of Biperiden as a Disease Modifying Agent After Traumatic Brain Injury: a Placebo Controlled, Randomized, Double Blind Study
试验速览
- 阶段
- 3 期
- 状态
- 终止
- 发起方
- 入组人数
- 123
- 试验地点
- 1
- 主要终点
- Clinical Outcome: Indidence of post-traumatic epilepsy
研究概览
简要总结
There is no AED or medication that has been demonstrated to affect the development of post-traumatic epilepsy. Biperiden is a cholinergic antagonist, acting in the muscarinic receptor, that is widely used as an anti Parkinson drug. The investigators data with animal models of epilepsy indicate that anti-muscarinic agents might affect the natural course of the disease in the case of post-traumatic epilepsy.
详细描述
Treatment with biperiden should be initiated in the first 12 hours after trauma as means to avoid the epileptogenic process. The treatment will be repeated every 6 hours for 10 consecutive days. The efficacy of biperiden as an antiepileptogenic drug will be established by analyzing the development of PTE between the biperiden and placebo groups. Several patients' aspects (clinical, electroencephalography, brain imaging, genetic and behavioral data) will be monitored for two year follow-up to unravel the mechanisms by which biperiden exerts its actions on epileptogenesis. The investigators are already at the early stages of patient's recruitment using the available resources.
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •between 18 and 75 year of age
- •patients with a diagnosis of acute TBI admitted to an emergency unit within 12 hours of the accident, regardless of the accident
- •brain CT scan with signs of acute intraparenchymatous contusion
- •signed informed consent (possibly by a relative)
排除标准
- •malignant neoplasia and other severe comorbidities
- •neurodegenerative disorders
- •previous cerebrovascular accident
- •record of convulsive seizures or use of anti-epileptic medication
- •pregnancy
- •concomitant use of the other anticholinergic medications
- •presence of any factor that may contraindicate the use of biperiden
- •participation in other clinical trial
- •alcohol intoxication will not lead to exclusion of the subject.
研究组 & 干预措施
Placebo
5mg IV(in the vein)every 6 hours for 10 days
干预措施: Placebo (Drug)
Biperiden Lactate
5mg IV(in the vein)every 6 hours for 10 days
干预措施: Biperiden Lactate (Drug)
结局指标
主要结局
Clinical Outcome: Indidence of post-traumatic epilepsy
时间窗: 24 months after TBI
The incidence of seizures will be evaluated starting immediately after TBI and continuously during the hospitalization period and after hospital discharge during the two year follow up period. Patients and their relatives will be asked to maintain a diary of seizures, and thus record all seizures with detailed descriptions of each event. The recordings will be evaluated in each patient visit. Seizures incidence will be compared between placebo and biperiden-treated patients.
次要结局
- Frequency of seizures(24 months after TBI)
- Mortality and adverse effects(24 months after TBI)
研究者
Luiz Eugenio Mello
Full Professor
Federal University of São Paulo