Metformin Efficacy and Safety in Epileptic Patients

NCT ID: NCT05722951

Last Updated: 2024-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-18

Study Completion Date

2024-06-20

Brief Summary

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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

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Conditions

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Epilepsy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group (+ve control)

levetiracetam \&/or sodium valproate

Group Type ACTIVE_COMPARATOR

Levetiracetam &/or sodium valproate

Intervention Type DRUG

levetiracetam \&/or sodium valproate will be given to 30 patients and monitored for 6 months

Treatment group

metformin + (levetiracetam \&/or sodium valproate)

Group Type EXPERIMENTAL

Levetiracetam &/or sodium valproate

Intervention Type DRUG

levetiracetam \&/or sodium valproate will be given to 30 patients and monitored for 6 months

Metformin

Intervention Type DRUG

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

Interventions

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Levetiracetam &/or sodium valproate

levetiracetam \&/or sodium valproate will be given to 30 patients and monitored for 6 months

Intervention Type 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

Intervention Type DRUG

Other Intervention Names

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Levetiracetam &/or valproic acid

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Tanta University

OTHER

Sponsor Role lead

Responsible Party

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Omnia Ashraf Abd El Aziz Ahmed

Teacher Assisstant

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Omnia Ashraf Abd El Aziz Ahmed Kotb

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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0107353

Identifier Type: -

Identifier Source: org_study_id