Metformin Efficacy and Safety in Epileptic Patients

Tanta University

Status and phase: Completed; Phase 3

Conditions: Epilepsy

Treatments: Drug: Levetiracetam &/or sodium valproate; Drug: Metformin

Study type: Interventional

Funder types: Other

Identifiers

NCT05722951

0107353

Details and patient eligibility

About

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

Enrollment: 60 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Control group (+ve control)

Active Comparator group

Description:

levetiracetam \&/or sodium valproate

Treatment:

Drug: Levetiracetam &/or sodium valproate

Treatment group

Experimental group

Description:

metformin + (levetiracetam \&/or sodium valproate)

Treatment:

Drug: Metformin

Drug: Levetiracetam &/or sodium valproate