Metformin Efficacy and Safety in Epileptic Patients

Phase 3

Completed

• Conditions: Epilepsy
• Interventions: Drug: Levetiracetam &/or sodium valproate; Drug: Metformin

• Registration Number: NCT05722951
• Lead Sponsor: Tanta University

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

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-18
• Study First Submitted: 2023-02-01
• Study First Submitted QC: 2023-02-01
• Study First Posted: 2023-02-10
• Primary Completion: 2024-06-20
• Study Completion: 2024-06-20
• Status Verified: 2024-11
• Last Update Submitted: 2024-11-27
• Last Update Posted: 2024-12-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 60

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group (+ve control)	Levetiracetam &/or sodium valproate	levetiracetam \&/or sodium valproate
Treatment group	Levetiracetam &/or sodium valproate	metformin + (levetiracetam \&/or sodium valproate)
Treatment group	Metformin	metformin + (levetiracetam \&/or sodium valproate)

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change in BMI	6 months
Change in biological markers	6 months	eg. serum lactate.

Trial Locations

Locations (1)

Omnia Ashraf Abd El Aziz Ahmed Kotb; 🇪🇬 Alexandria, Egypt