Metformin Efficacy and Safety in Epileptic Patients

Last updated: November 27, 2024
Sponsor: Tanta University
Overall Status: Completed

Phase

3

Condition

Epilepsy

Treatment

Metformin

Levetiracetam &/or sodium valproate

Clinical Study ID

NCT05722951
0107353
  • Ages 18-65
  • All Genders

Study 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

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Age: 18 - 65 years old

  • Obese and overweight patients with body mass index (BMI) ≥ 25.

  • Diabetic & non diabetic patients.

Exclusion

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 increasethe risk of lactic acidosis (e.g. cardiac/respiratory failure, recent myocardialinfarction).

  • Patients who are already taking metformin.

  • Cancer patients.

  • Pregnant or lactating women.

  • Patients with known hypersensitivity to the drug.

Study Design

Total Participants: 60
Treatment Group(s): 2
Primary Treatment: Metformin
Phase: 3
Study Start date:
October 18, 2022
Estimated Completion Date:
June 20, 2024

Connect with a study center

  • Omnia Ashraf Abd El Aziz Ahmed Kotb

    Alexandria,
    Egypt

    Site Not Available

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