CTRI/2021/03/032317已完成Phase 3 4
"Fenofibrate as adjuvant therapy in persons with active epilepsy: a double blind, randomized, placebo- controlled study"
适应症
试验速览
- 阶段
- Phase 3 4
- 状态
- 已完成
- 入组人数
- 72
- 试验地点
- 1
- 主要终点
- To find out the percentage change in seizure frequency after 6 months of fenofibrate supplementation in persons with epilepsy on antiepileptic drugs.
研究概览
简要总结
Treatment with antiepileptic drugs (AEDs) may reduce symptoms of seizures but does not influence the course of the disease. Hence, the current study aims to determine the adjuvant role of fenofibrate therapy for 6 months on seizure control, metabolic status, and quality of life in persons with epilepsy (PWE). This study will be a double-blind placebo-controlled trial and will be conducted upon PWE. Patients of both groups will be followed-up at 2 and 6 months of supplementation and all the parameters assessed in the baseline will be re-evaluated. Any adverse events during the intervention will be monitored and reported to corresponding authorities.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Clinically diagnosed persons with active epilepsy (PWE) with at least 2 seizures in the last 3 months
- •Either male or female subject of 18 to 50 years old age
- •Pharmacoresistance to at least one tolerated and appropriately chosen and used AED schedules to achieve sustained seizure freedom
- •Patient ready to give informed consent
- •Ability to maintain seizure diary.
排除标准
- •Pregnant or seeking pregnancy and nursing mother
- •Patient undergoing AED tapering
- •Patient on a statin or HMG Co-A reductase inhibitor
- •Patient with active liver disease or persistent liver dysfunction
- •Patient with severe renal impairment or undergoing dialysis
- •Patient with gallstone or biliary diseases
- •Patient with known cardiac diseases, diabetes, and hypothyroidism
- •The patient refuses to give informed consent
- •Patienton any other drugs known to cause interaction with AEDs (e.g. isoniazid, fluoxetine, fluvoxamine, clarithromycin, erythromycin, fluconazole, etc.) or with fenofibrate (e.g. coumarin anticoagulants, bile acid-binding resins, immunosuppressants, colchicine, diuretics, hormonal contraceptives, and beta-blockers, etc.)
- •Patient on the drug known to alter seizure threshold (e.g. INH, theophylline, metronidazole, etc.)
- •A person with known hypersensitivity to fenofibrate
- •Poor compliance with AEDs.
结局指标
主要结局
To find out the percentage change in seizure frequency after 6 months of fenofibrate supplementation in persons with epilepsy on antiepileptic drugs.
时间窗: 2 Years
次要结局
- 1.To find out the rate of drug responder after 6 months of fenofibrate supplementation in persons with epilepsy on antiepileptic drugs.(2 years)
- 2. To find out the effect on the quality of life using QOLIE-10 questionnaire(2 Years)
- 3. To assess safety outcomes(a. Complete Blood Counts (CBC), Liver Function Test (LFT), Renal Function Test (RFT), and Lipid profile)
- 4.To assess the effect on oxidative stress parameters i.e. serum malondialdehyde (MDA), reduced glutathione (GSH) level(2 Years)
研究者
研究点 (1)
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