TCTR20210925001招募中2 期
Role of etifoxine, as an adjunctive treatment in patients diagnosed with medically resistant focal epilepsy with comorbid anxiety symptoms
Faculty Pharmaceutical Science Burapha University0 个研究点目标入组 40 人开始时间: 2021年9月25日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 40
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 20 Years 至 80 Years（—）
- 性别
- All
入选标准
- •1 Age more than 20 years old
- •2 Diagnosed with medically resistant focal epilepsy
- •2.1 Average seizure frequency more than 3 times/month, determine from the past 3 months with on at least two antiepileptic drugs (AEDs) or expose to at least 2 sequential monotherapy, with proper dosage no history of poor compliance to AEDs
- •3 Comorbid mild to sever anxiety symptoms defined as HAMA score of more than 1 point
- •4 Can maintainable the same concomitant AEDs, other neuropsychiatric medications and hormonal medications with stable dosage throughout the study
- •4.1 From 1 months before the study to entire 3 months after the enrolment
- •4.2 Allow a rescue medications i.e. a benzodiazepine medicine only 1 to 2 time a week
- •5 In reproductive potential patients, must accept to use at least one methods of birth control
排除标准
- •1. Any history or presence of hepatic disease
- •2. Myasthenia gravis
- •3 Patients with congenital galactosemia, glucose and galactose malabsorption syndrome or lactase deficit
- •4 Unsuitable veins for repeated venipuncture
- •5 Inability or difficulty swallowing whole capsules
- •6 History of alcohol abuse
- •7 Pregnancy, lactation and plan to conceive
- •8 Simultaneous participation to a clinical trial or in exclusion period of a previous clinical trial
- •9 Any condition or personal circumstance that, in the opinion of the investigator, renders the subject unlikely or unable to comply with the full study protocol
- •10 Currently taking more than 2 antidepressants
- •11 Currently taking more than 2 benzodiazepines
- •12 Currently taking ONLY 1 benzodiazepine but the dosage is very high: alprazolam (10 mg/d), diazepam (40 mg/d), chlordiazepoxide (100 mg/d), clobazam (40 mg/d), clonazepam (40 mg/d), flunitrazepam (2 mg/d), lorazepam (10 mg/d) , midazolam (20 mg/d)
- •13 Currently taking morphine or its derivative, antipsychotic agents, recreational agents CBD, etc., herbal medicines (Withdrawal period must be at least 3 months before screening.)
- •14 History of poor medication adherence
- •15 Baseline GFR less than 30 ml/min
- •16 Advance cancer or severe medical conditions
- •17 Severe psychiatric illness and history of suicidal idea or attempts
- •18 Previous history of status epilepticus within 1 year
- •19 Currently on etifoxine or progesterone therapy
- •20 Previous history of allergic to etifoxine or progesterone
研究者
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