Health Condition 1: G409- Epilepsy, unspecified Health Condition 2: G89-G99- Other disorders of the nervous system
Conditions
Interventions
Intervention1: Metformin: Oral Anti-diabetic agent
500mg OD orally for 6 months
Control Intervention1: Placebo: Methyl cellulose one capsule daily for 6 months
Sponsors
Ratnav Singh
Eligibility
Inclusion criteria
Inclusion criteria: 1) Clinically diagnosed persons with active epilepsy (PWE) with at least 2 seizures in the past 3 months and on a stable AEDs treatment regimen for last one month. 2) Either male or female subject of 18 to 60 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 with active liver disease or persistent liver dysfunction, gallstones or biliary disease 4) Patient with severe renal impairment (eGFR 5) Patient with known cardiac diseases including heart failure, severe pulmonary disease, chronic alcoholism, sepsis, severe vitamin B12 deficiency. 6) Patienton any other drugs known to alter seizure threshold or cause interactions with AEDs (e.g. isoniazid, theophylline, metronidazole, fluoxetine, fluvoxamine, clarithromycin, erythromycin, fluconazole, etc.) or with metformin (e.g. cimetidine, nifedipine, furosemide etc.) 7) Patient already on metformin therapy for the past 3 months or with a known hypersensitivity to metformin 8) Poor compliance with AEDs
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Reduction in mean monthly convulsive seizure frequency in persons with active epilepsy by giving metformin as an adjuvant for a period of 6 months in addition to ongoing AEDs as compared to a placebo.Timepoint: Assessed at baseline and 6 months | — |
Secondary
| Measure | Time frame |
|---|---|
| Oxidative Stress mTOR expression analysis Body composition QOLIE-10 analysisTimepoint: 6 months | — |
Countries
India
Contacts
Public ContactDr Ratnav Singh
All India Institute of Medical Sciences New Delhi
Outcome results
None listed