Fenofibrate as adjuvant therapy in persons with active epilepsy: a double blind, randomized, placebo- controlled study -

Department of Pharmacology0 个研究点目标入组 80 人开始时间: 待定最近更新: 2024年6月24日

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•1. Clinically diagnosed persons with active epilepsy (PWE) with at least 2 seizures in the last 3 months
•2. Either male or female subject of 18 to 50 years old age
•3. Pharmacoresistance to at least one tolerated and appropriately chosen and used AED schedules to achieve sustained seizure freedom
•4. Patient ready to give informed consent
•5. Ability to maintain seizure diary

•1. Pregnant or seeking pregnancy and nursing mother
•2. Patient undergoing AED tapering
•3. Patient on a statin or HMG Co-A reductase inhibitor
•4. Patient with active liver disease or persistent liver dysfunction
•5. Patient with severe renal impairment or undergoing dialysis
•6. Patient with gallstone or biliary diseases
•7. Patient with known cardiac diseases, diabetes, and hypothyroidism
•8. The patient refuses to give informed consent
•9. 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.)
•10. Patient on the drug known to alter seizure threshold (e.g. INH, theophylline, metronidazole, etc.)
•11. A person with known hypersensitivity to fenofibrate
•12. Poor compliance with AEDs

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