A clinical trial to study the effect of fenofibrate or placebo supplementation along with antiepileptic therapy in persons with epilepsy

Phase 3

Completed

Conditions: Health Condition 1: G409- Epilepsy, unspecified

Registration Number: CTRI/2021/03/032317

Lead Sponsor: Department of Pharmacology

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Completed

Sex: Not specified

Target Recruitment: 80

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

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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 <br/ ><br>a. Complete Blood Counts (CBC), Liver Function Test (LFT), Renal Function Test (RFT), and Lipid profile <br/ ><br>b.Muscular weakness or myopathy by clinical assessment using handgrip dynamometer and creatinine phosphokinase level <br/ ><br>c. Body Composition Analysis using Bioelectrical Impedance Body Composition Analyzer (BIA) <br/ ><br>d. Adverse Drug Reactions (ADRs) monitoring using Liverpool Adverse Events Profile (LAEP) score <br/ ><br>Timepoint: 2 Years;4.To assess the effect on oxidative stress parameters i.e. serum malondialdehyde (MDA), reduced glutathione (GSH) levelTimepoint: 2 Years