The Effect of Metformin As an Adjuvant Therapy on Immunological Parameters in Egyptian Patients with RRMS: a Pilot Study

February 2, 2025 updated by: Mohamed Youssef Elsayed, German University in Cairo
This pilot study aims to investigate the tolerability and feasibility of using metformin as an adjuvant treatment for RRMS. Also, it aims to evaluate the preliminary evidence of its efficacy by analyzing outcomes related to immunology, clinical manifestations, and radiological findings.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

30

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 1053
        • Nasser Institute for Research and Treatment

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Individuals between 18 and 50 years of age who met the 2017 McDonald criteria were recruited.
  • Patients with RRMS and had an EDSS score below 7.0.
  • Participants were required to have been on a stable IFNβ-1a regimen for at least six months before the commencement of the study.

Exclusion Criteria:

  • Individuals taking metformin or other diabetes medications, pregnant, and breastfeeding females were excluded.
  • Those with congestive heart failure, liver impairment, kidney dysfunction, or chronic respiratory conditions were not eligible to participate.
  • Additionally, patients who had undergone corticosteroids before or within 4 weeks of the study's commencement were ineligible for participation.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control group
Active Comparator: Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®)
Other: Usual Care
Active Comparator: Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®)
Experimental: Intervention group
Experimental: Metformin (Cidophage®) and Interferon Beta 1 a (Rebiff ® 44mcg or Avonex ®) Metformin 1000 mg (Cidophage® 1000 mg tablets, CID, Giza, Egypt) tablet twice daily for 6 months as add on therapy with Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®).
Drug: Metformin (Cidophage®)
Antidiabetic agent used to treat type 2 diabetes, and to prevent type 2 diabetes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in serum levels of neurofilament light chain in both arms
Time Frame: After 6 months
After 6 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in serum levels of nuclear factor kappa B in both arms
Time Frame: After 6 months
After 6 months
Degree of remyelination visualized by MRI, it depends on clinician's overview.
Time Frame: After 6 months
After 6 months
Degree of disability assessed by Expanded Disability Status Scale.
Time Frame: After 6 months
After 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

German University in Cairo

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 1, 2022

Primary Completion (Actual)

May 30, 2023

Study Completion (Actual)

January 30, 2025

Study Registration Dates

First Submitted

February 2, 2025

First Submitted That Met QC Criteria

February 2, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 2, 2025

Last Verified

April 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • MET in sNFL and NFK-B

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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