A prospective observational study to find out correlation of serum antiepileptic drug (AED) and biomarkers levels with seizure recurrence in persons with epilepsy (PWE) undergoing AED tapering
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 330
- 试验地点
- 1
- 主要终点
- Rate of seizure recurrence in PWE on monotherapy undergoing AED tapering with minimum 1 year follow up period
研究概览
简要总结
The study is to see seizure recurrence in persons with epilepsy undergoing antiepileptic drug tapering and to correlate this with serum AED level and inflammatory biomarkers. Thisstudy will find out variety of predictors i.e. factors correlated with seizurerecurrence in PWE. Though AED serum level monitoring is routinely done duringAED treatments, its scope during AED withdrawal is not established. Identifyingthe association of baseline trace elements levels and cytokines levels withseizure recurrence could have role in optimizing AED withdrawal. The actualincidence of seizure recurrence in PWE undergoing AED tapering in a tertiaryhospital set up can be estimated. Thus the study result will aid in bettermanagement of PWE undergoing AED withdrawal.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed persons with epilepsy (PWE)
- •Either male or female, age more than 18 years
- •On monotherapy of AEDs (valproic acid, carbamazepine, phenytoin and levetiracetam)
- •Two years seizure freedom or longer
- •PWE going to start AED tapering
- •Patient ready to give informed consent.
排除标准
- •Juvenile myoclonic epilepsy
- •Pregnant or seeking pregnancy
- •Associated neurological diseases other than epilepsy
- •Patient on drugs known to alter seizure threshold (e.g. INH, theophylline, metronidazole etc.)
- •Patient with significant hepatic and renal impairment that may require dose alteration
- •Patient on anti tubercular drugs or any other drugs known to cause interaction with AEDs (e.g. isoniazid, fluoxetine, fluvoxamine, clarithromycin, erythromycin, fluconazole etc.)
- •Patient on food or dietary supplements like grape fruit juice and ginkgo biloba which are known to cause interaction with AEDs
- •Any associated psychiatric disorder
- •Patient refuses to give informed consent.
结局指标
主要结局
Rate of seizure recurrence in PWE on monotherapy undergoing AED tapering with minimum 1 year follow up period
时间窗: 1 year follow up period
次要结局
- ï‚—Correlation between the lowering of serum AED concentration with seizure recurrence in PWE on monotherapy undergoing AED tapering(1 year follow up period)
- ï‚—Correlation of the following factors with seizure recurrence with treatment, seizure, inflammatory biomarkers- TNF alpha, IL-1 beta(1 year follow up period)