Metformin Efficacy and Safety in Epileptic Patients

• Sponsor: Tanta University (Other)
• Overall Status: Recruiting
• CT.gov ID: NCT05722951
• Collaborator: (none)
• Enrollment: 60
• Location: 1
• Arms: 2
• Anticipated Duration (Months): 11.4
• Patients Per Site Per Month: 5.2

Study Details

Study Description

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).

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

Condition or Disease	Intervention/Treatment	Phase
Epilepsy	Drug: Levetiracetam; Drug: Metformin	Phase 3

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 60 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: Metformin Efficacy and Safety in Epileptic Patients
• Actual Study Start Date: Oct 18, 2022
• Anticipated Primary Completion Date: Oct 1, 2023
• Anticipated Study Completion Date: Oct 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Control group levetiracetam	Drug: Levetiracetam; levetiracetam will be given to 30 patients and monitored for 6 months
Experimental: Treatment group metformin	Drug: Levetiracetam; levetiracetam will be given to 30 patients and monitored for 6 months; Drug: 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

Outcome Measures

Primary Outcome Measures

1. Seizures Frequency [6 months]

   will be recorded using seizures diary.

2. Seizures Severity [6 months]

   will be measured using chalfont seizures severity scale.

3. Quality of Life level [6 months]

   will be recorded using SF-36 health survey.

Secondary Outcome Measures

1. Change in BMI [6 months]

2. Change in biological markers [6 months]

   the biological markers measured: serum Gamma Amino butyric Acid (GABA), serum AMP-activated protein kinase (AMPK) protein and serum lactate.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 65 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Omnia Ashraf Abd El Aziz Ahmed Kotb	Alexandria		Egypt

Sponsors and Collaborators

• Tanta University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Omnia Ashraf Abd El Aziz Ahmed, Teacher Assisstant, Tanta University
• ClinicalTrials.gov Identifier: NCT05722951
• Other Study ID Numbers: 0107353
• First Posted: Feb 10, 2023
• Last Update Posted: Feb 10, 2023
• Last Verified: Sep 1, 2022

• 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
• Additional relevant MeSH terms: Epilepsy; Metformin; Levetiracetam

Study Results

No Results Posted as of Feb 10, 2023