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OpenTrials
Completed

NCT Number: NCT05722951

Metformin Efficacy and Safety in Epileptic Patients

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

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Key information

Conditions

Epilepsy Brain Diseases Central Nervous System Diseases Nervous System Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Omnia Ashraf Abd El Aziz Ahmed Kotb

Alexandria, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Levetiracetam &/or sodium valproate

Drug

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

Other names: Levetiracetam &/or valproic acid

metformin

Drug

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

Primary outcomes

  1. Seizures Frequency

    Time frame: 6 months

    will be recorded using seizures diary.

  2. Seizures Severity

    Time frame: 6 months

    will be measured using chalfont seizures severity scale.

  3. Quality of Life level

    Time frame: 6 months

    will be recorded using SF-36 health survey.

Secondary outcomes

  1. Change in BMI

    Time frame: 6 months

  2. Change in biological markers

    Time frame: 6 months

    eg. serum lactate.

Sponsors and collaborators

Lead sponsor

Tanta University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Feb 10, 2023
Registry last updated
Dec 2, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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