Metformin Efficacy and Safety in Epileptic Patients

November 27, 2024 updated by: Omnia Ashraf Abd El Aziz Ahmed, Tanta University

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

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

60

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Omnia Ashraf Abd El Aziz Ahmed Kotb

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group (+ve control)
levetiracetam &/or sodium valproate
Drug: Levetiracetam &/or sodium valproate
levetiracetam &/or sodium valproate will be given to 30 patients and monitored for 6 months
Other Names:
  • Levetiracetam &/or valproic acid
Experimental: Treatment group
metformin + (levetiracetam &/or sodium valproate)
Drug: Levetiracetam &/or sodium valproate
levetiracetam &/or sodium valproate will be given to 30 patients and monitored for 6 months
Other Names:
  • Levetiracetam &/or valproic acid
Drug: Metformin
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

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in BMI
Time Frame: 6 months
6 months
Change in biological markers
Time Frame: 6 months
eg. serum lactate.
6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Tanta University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 18, 2022

Primary Completion (Actual)

June 20, 2024

Study Completion (Actual)

June 20, 2024

Study Registration Dates

First Submitted

February 1, 2023

First Submitted That Met QC Criteria

February 1, 2023

First Posted (Actual)

February 10, 2023

Study Record Updates

Last Update Posted (Estimated)

December 2, 2024

Last Update Submitted That Met QC Criteria

November 27, 2024

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 0107353

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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