Health Condition 1: G409- Epilepsy, unspecified
Conditions
Interventions
Intervention1: Fenofibrate: Patients of Fenofibrate arm will receive oral fenofibrate supplementation for 6 months (fenofibrate tablet 145 mg once a day for 6 months) along with ongoing antiepileptic
Sponsors
Department of Pharmacology
Eligibility
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria
Exclusion criteria: 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To find out the percentage change in seizure frequency after 6 months of fenofibrate supplementation in persons with epilepsy on antiepileptic drugs.Timepoint: 2 Years | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To find out the rate of drug responder after 6 months of fenofibrate supplementation in persons with epilepsy on antiepileptic drugs.Timepoint: 2 years;2. To find out the effect on the quality of life using QOLIE-10 questionnaireTimepoint: 2 Years;3. To assess safety outcomes a. Complete Blood Counts (CBC), Liver Function Test (LFT), Renal Function Test (RFT), and Lipid profile b. Muscular weakness or myopathy by clinical assessment using handgrip dynamometer and creatinine phosphokinase level c. Body Composition Analysis using Bioelectrical Impedance Body Composition Analyzer (BIA) d. Adverse Drug Reactions (ADRs) monitoring using Liverpool Adverse Events Profile (LAEP) score Timepoint: 2 Years;4. To assess the effect on oxidative stress parameters i.e. serum malondialdehyde (MDA), reduced glutathione (GSH) levelTimepoint: 2 Years | — |
Countries
India
Contacts
Public ContactDr Mendapara Nipaben Harjivanbhai
All India Institute of Medical Sciences, New Delhi
Outcome results
None listed