Back to resultsMetformin Efficacy and Safety in Epileptic Patients
Primary Purpose
Epilepsy
Status
Recruiting
Phase
Phase 3
Locations
Egypt
Study Type
Interventional
Intervention
Levetiracetam
Metformin
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy
Eligibility Criteria
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.
Sites / Locations
- Omnia Ashraf Abd El Aziz Ahmed KotbRecruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
Experimental
Arm Label
Control group
Treatment group
Arm Description
levetiracetam
metformin
Outcomes
Primary Outcome Measures
Seizures Frequency
will be recorded using seizures diary.
Seizures Severity
will be measured using chalfont seizures severity scale.
Quality of Life level
will be recorded using SF-36 health survey.
Secondary Outcome Measures
Change in BMI
Change in biological markers
the biological markers measured: serum Gamma Amino butyric Acid (GABA), serum AMP-activated protein kinase (AMPK) protein and serum lactate.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05722951
Brief Title
Metformin Efficacy and Safety in Epileptic Patients
Official Title
Metformin Efficacy and Safety in Epileptic Patients
Study Type
Interventional
2. Study Status
Record Verification Date
September 2022
Overall Recruitment Status
Recruiting
Study Start Date
October 18, 2022 (Actual)
Primary Completion Date
October 2023 (Anticipated)
Study Completion Date
October 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Tanta University
4. Oversight
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
Data Monitoring Committee
No
5. 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
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Control group
Arm Type
Active Comparator
Arm Description
levetiracetam
Arm Title
Treatment group
Arm Type
Experimental
Arm Description
metformin
Intervention Type
Drug
Intervention Name(s)
Levetiracetam
Intervention Description
levetiracetam will be given to 30 patients and monitored for 6 months
Intervention Type
Drug
Intervention Name(s)
Metformin
Intervention Description
metformin + levetiracetam will be given to 30 patients and monitored for 6 months will be given to 30 patients and monitored for 6 months
Primary Outcome Measure Information:
Title
Seizures Frequency
Description
will be recorded using seizures diary.
Time Frame
6 months
Title
Seizures Severity
Description
will be measured using chalfont seizures severity scale.
Time Frame
6 months
Title
Quality of Life level
Description
will be recorded using SF-36 health survey.
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Change in BMI
Time Frame
6 months
Title
Change in biological markers
Description
the biological markers measured: serum Gamma Amino butyric Acid (GABA), serum AMP-activated protein kinase (AMPK) protein and serum lactate.
Time Frame
6 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Omnia Kotb
Phone
002/01111532190
Email
Omnia.kotb@outlook.com
First Name & Middle Initial & Last Name or Official Title & Degree
Omnia Kotb
Phone
002/01017448044
Email
Omnia.ashraf.student@pua.edu.eg
Facility Information:
Facility Name
Omnia Ashraf Abd El Aziz Ahmed Kotb
City
Alexandria
Country
Egypt
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sahar Hegazy
12. IPD Sharing Statement
Learn more about this trial
Metformin Efficacy and Safety in Epileptic Patients
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