Metformin Efficacy and Safety in Epileptic Patients

Status

Completed

Phases

Phase 3

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05722951

Enrollment

Registered

2023-02-10

Start date

2022-10-18

Completion date

2024-06-20

Last updated

2024-12-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Epilepsy

Brief summary

The goal of this clinical trial is to Evaluating Metformin Efficacy and Safety when Co-administered with Antiepileptic Drugs in Patients with Seizures. The main question it aims to answer is: * Does metformin have beneficial effect on epileptic patients? * How metformin can affect epileptic patient's health? Participants will be divided into 2 groups (control group and treatment group) * Control group will receive standard treatment (levetiracetam &/or sodium valproate). * Treatment group will receive standard treatment (levetiracetam &/or sodium valproate) + metformin

Interventions

DRUGLevetiracetam &/or sodium valproate

levetiracetam &/or sodium valproate will be given to 30 patients and monitored for 6 months

DRUGMetformin

metformin + (levetiracetam &/or sodium valproate) will be given to 30 patients and monitored for 6 months will be given to 30 patients and monitored for 6 months

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 65 Years

Healthy volunteers

Inclusion criteria

* Age: 18 - 65 years old * Obese and overweight patients with body mass index (BMI) ≥ 25. * Diabetic & non diabetic patients.

Exclusion criteria

* Patients with severe liver damage or kidney disease (eGFR below 45mL/min/1.73 m²). * Patients having acute or chronic disease which may cause tissue hypoxia and increase the risk of lactic acidosis (e.g. cardiac/respiratory failure, recent myocardial infarction). * Patients who are already taking metformin. * Cancer patients. * Pregnant or lactating women. * Patients with known hypersensitivity to the drug.

Design outcomes

Primary

Measure	Time frame	Description
Seizures Frequency	6 months	will be recorded using seizures diary.
Seizures Severity	6 months	will be measured using chalfont seizures severity scale.
Quality of Life level	6 months	will be recorded using SF-36 health survey.

Secondary

Measure	Time frame	Description
Change in BMI	6 months	—
Change in biological markers	6 months	eg. serum lactate.

Countries

Egypt

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026