Role of prophylactic levetiracetam in CNS Tuberculosis: A randomized double-blind placebo-controlled study
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Occurrence of first epileptic seizure or till 3 months follow-up period
研究概览
简要总结
Seizures are among the most common complication of CNS TB reported between 11.3-37.6%. Studies have consistently found that the presence of seizures in CNS-TB leads to a four-fold increase in the risk of death and neurological deficit. Advanced stage, cortical involvement and epileptiform discharges are independent risk factors to occurrence of recurrent seizures in CNS TB
Primary Objective
To study the role of prophylactic Levetiracetam in preventing seizure occurrence in patients
of CNS Tuberculosis at high risk for seizures.
Secondary Objective
To study the effect of prophylactic levetiracetam in improving functional outcome in such
patients.
Methodology
This randomized double blind placebo controlled study will consist of patient of CNS tuberculosis. There will be two groups one interventional group and other comparator group who will be given trial medication in the dose of 20 mg/kg in two divided doses and gradually increased by 10 mg/kg every 3rd day to a maintenance dose of 40 mg/kg/day in two divided doses (upper limit 4gm/day). This will continue for the entire study period and after 12 weeks, the trial medication will be tapered off by 250 mg each 3 days and eventually discontinued. If patient reports intolerable side effects in which case the drug dose will be decreased to the
tolerable level, but not below 20 mg/kg/day. If patient does not tolerate the lowest permissible dose, it will be stopped and the side effects will be managed free of cost as per standard of care. If patient has a seizure in the follow-up period, another anti-seizure medication (ASM) other than levetiracetam will be added as per acute symptomatic seizure management guidelines. Patient will be followed up after 7 days, 30 days and 60 days to enquire about history of any possible epileptic seizures & any drug-related side effects which will be assessed by SIDEADquestionnaire. The follow-up will be done on a OPD basis or telephonically if OPD follow up not possible. Final follow-up will be done at 90 days. Parameters like patient mRS, seizure occurrence, adverse effects of ASM (SIDEAD), BI will be recorded by direct face-to-face patient interaction.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 13.00 Year(s) 至 85.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with CNS Tuberculosis will be included fulfilling following criteria:
- •Within 6 months of diagnosis
- •At high risk for seizures that will include one or more of the following: A.
- •Grade II and III MRC stage B.
- •Epileptiform discharges on EEG C.
- •Abnormal neuroimaging (supra-tentorial tuberculoma or abscess or leptomeningeal enhancement or cortical infarct or hydrocephalus).
排除标准
- •Age less than or equal to 12 years
- •Diagnosed case of seizure disorder or taking anti-seizure medication
- •Advanced kidney or liver disease
- •Pregnancy or breastfeeding
- •Contraindication to the use of Levetiracetam (significant neuropsychiatric symptoms, depression, psychosis).
结局指标
主要结局
Occurrence of first epileptic seizure or till 3 months follow-up period
时间窗: At baseline, 4 weeks, 8 weeks and 12 weeks
次要结局
- A. Seizure related- Seizure severity of first seizure occurrence (Focal or generalized)(B. Functional outcome-related)
研究者
Dr Swapan Gupta
GB Pant Institute of Post Graduate Medical Education and Research, New Delhi