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Completed

NCT Number: NCT06812585

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

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.

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Key information

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting Autoimmune Diseases Autoimmune Diseases of the Nervous System Demyelinating Autoimmune Diseases, CNS Demyelinating Diseases Immune System Diseases Multiple Sclerosis Multiple Sclerosis, Relapsing-Remitting Nervous System Diseases

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Nasser Institute for Research and Treatment

Cairo, Cairo Governorate, 1053, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Metformin (Cidophage®)

Drug

Antidiabetic agent used to treat type 2 diabetes, and to prevent type 2 diabetes.

Usual Care

Other

Active Comparator: Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®)

Primary outcomes

  1. Change in serum levels of neurofilament light chain in both arms

    Time frame: After 6 months

Secondary outcomes

  1. Change in serum levels of nuclear factor kappa B in both arms

    Time frame: After 6 months

  2. Degree of remyelination visualized by MRI, it depends on clinician's overview.

    Time frame: After 6 months

  3. Degree of disability assessed by Expanded Disability Status Scale.

    Time frame: After 6 months

Sponsors and collaborators

Lead sponsor

German University in Cairo

Other

Registry information

Important dates

Study start
2022
Primary completion
2023
Study completion
2025
First posted
Feb 6, 2025
Registry last updated
Feb 6, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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