NCT05722951

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
60

participants targeted

Target at below P25 for phase_3

Timeline
Completed

Started Oct 2022

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 18, 2022

Completed
4 months until next milestone

First Submitted

Initial submission to the registry

February 1, 2023

Completed
9 days until next milestone

First Posted

Study publicly available on registry

February 10, 2023

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 20, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2024

Completed
Last Updated

December 2, 2024

Status Verified

November 1, 2024

Enrollment Period

1.7 years

First QC Date

February 1, 2023

Last Update Submit

November 27, 2024

Conditions

Epilepsy

Outcome Measures

Primary Outcomes (3)

  • Seizures Frequency

    will be recorded using seizures diary.

    6 months

  • Seizures Severity

    will be measured using chalfont seizures severity scale.

    6 months

  • Quality of Life level

    will be recorded using SF-36 health survey.

    6 months

Secondary Outcomes (2)

  • Change in BMI

    6 months

  • Change in biological markers

    6 months

Study Arms (2)

Control group (+ve control)

ACTIVE COMPARATOR

levetiracetam \&/or sodium valproate

Drug: Levetiracetam &/or sodium valproate

Treatment group

EXPERIMENTAL

metformin + (levetiracetam \&/or sodium valproate)

Drug: Levetiracetam &/or sodium valproateDrug: Metformin

Interventions

Levetiracetam &/or sodium valproateDRUG

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

Also known as: Levetiracetam &/or valproic acid
Control group (+ve control)Treatment group
MetforminDRUG

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

Treatment group

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age: 18 - 65 years old
  • Obese and overweight patients with body mass index (BMI) ≥ 25.
  • Diabetic \& non diabetic patients.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Omnia Ashraf Abd El Aziz Ahmed Kotb

Alexandria, Egypt

Location

MeSH Terms

Conditions

Epilepsy

Interventions

LevetiracetamValproic AcidMetformin

Condition Hierarchy (Ancestors)

Brain DiseasesCentral Nervous System DiseasesNervous System Diseases

Intervention Hierarchy (Ancestors)

AcetamidesAmidesOrganic ChemicalsAcetatesAcids, AcyclicCarboxylic AcidsPyrrolidinonesPyrrolidinesHeterocyclic Compounds, 1-RingHeterocyclic CompoundsPentanoic AcidsValeratesFatty Acids, VolatileFatty AcidsLipidsBiguanidesGuanidinesAmidines

Study Design

Study Type
interventional
Phase
phase 3
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Teacher Assisstant

Study Record Dates

First Submitted

February 1, 2023

First Posted

February 10, 2023

Study Start

October 18, 2022

Primary Completion

June 20, 2024

Study Completion

June 20, 2024

Last Updated

December 2, 2024

Record last verified: 2024-11

Locations

EG(1)