se of metformin in addition to standard drugs to reduce incidence of seizures in epileptics

Not Applicable

Conditions: Health Condition 1: G409- Epilepsy, unspecifiedHealth Condition 2: G89-G99- Other disorders of the nervous system

Registration Number: CTRI/2023/10/058825

Lead Sponsor: Ratnav Singh

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Open to Recruitment

Sex: Not specified

Target Recruitment: 60

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

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 <45ml/min/1.73m 2) or undergoing dialysis

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

Study & Design

Study Type: Interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures