Metformin Efficacy and Safety in Epileptic Patients

Epilepsy Clinical Trial

Official title:

Metformin Efficacy and Safety in Epileptic Patients

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05722951
• Other study ID #: 0107353
• Status: Recruiting
• Phase: Phase 3
• Start date: October 18, 2022
• Est. completion date: October 2023

Study information

• Verified date: September 2022
• Source: Tanta University
• Contact: Omnia Kotb
• Phone: 002/01111532190
• Email: Omnia.kotb[@]outlook.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

• Treatment group will receive standard treatment (levetiracetam) + metformin

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: October 2023
• Est. primary completion date: October 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

Inclusion Criteria:

• Age: 18 - 65 years old

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

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.

• Diabetic patients.

• Cancer patients.

• Pregnant or lactating women.

• Patients with known hypersensitivity to the drug.

Related Conditions & MeSH terms

• Epilepsy

Intervention

Drug:
• Levetiracetam
levetiracetam will be given to 30 patients and monitored for 6 months
• Metformin
metformin + levetiracetam will be given to 30 patients and monitored for 6 months will be given to 30 patients and monitored for 6 months

Locations

Country	Name	City	State
Egypt	Omnia Ashraf Abd El Aziz Ahmed Kotb	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Seizures Frequency	will be recorded using seizures diary.	6 months
Primary	Seizures Severity	will be measured using chalfont seizures severity scale.	6 months
Primary	Quality of Life level	will be recorded using SF-36 health survey.	6 months
Secondary	Change in BMI		6 months
Secondary	Change in biological markers	the biological markers measured: serum Gamma Amino butyric Acid (GABA), serum AMP-activated protein kinase (AMPK) protein and serum lactate.	6 months