ClinicalTrials.gg
CompletedNCT06812585Updated Feb 6, 2025

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

A Phase 2 interventional study of Metformin (Cidophage®) and Usual Care in Multiple Sclerosis (MS) - Relapsing-remitting, sponsored by German University in Cairo. Completed at 1 site in Egypt. Open to participants aged 18 Years to 50 Years. Per ClinicalTrials.gov, last updated 2025-02-06.

Sponsored by German University in Cairo · Phase 2, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 10 months after the study started (first participant enrolled Apr 2022, registered Feb 2025).
Phase
Phase 2
Study type
Interventional
Enrollment
30
Allocation
Randomized
Ages
18 Years to 50 Years
Sex
All
01

Study summary

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.

02

Conditions studied

  • Multiple Sclerosis (MS) - Relapsing-remitting
03

In context

Multiple Sclerosis, Relapsing-Remitting

615 studies on the registry are indexed under Multiple Sclerosis, Relapsing-Remitting; 80 are open to participants now.

This study's enrollment of 30 is below the median of 72 across 437 interventional studies indexed under Multiple Sclerosis, Relapsing-Remitting.

Browse Multiple Sclerosis, Relapsing-Remitting studies →

Lead sponsor

German University in Cairo is the lead sponsor of 10 studies on the registry; 5 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 50 Years
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

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.
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
30 participants (actual)

Study arms

  • 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

  • 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®)

Interventions

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

  • OtherUsual Care

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

06

What researchers measure

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

07

Study locations

1 site
  • Nasser Institute for Research and Treatment
    Cairo, Cairo Governorate 1053, Egypt
08

References and documents

Publications

  • Abdelgaied MY, Abdelgawad O, Rashad MH, Solayman MH, El-Tayebi HM. Efficacy and tolerability of metformin as an adjuvant therapy in patients with relapse-remitting multiple sclerosis receiving interferon Beta 1a: A randomized pilot trial. J Neuroimmunol. 2026 Mar;412:578852. doi: 10.1016/j.jneuroim.2025.578852. Epub 2025 Dec 31. PubMed 41483718 ↗

Individual participant data

Plan to share: No

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 6, 2025, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT06812585
Lead sponsor
German University in Cairo
Responsible party
Mohamed Youssef Elsayed (The Effect of Metformin as an Adjuvant Therapy on Immunological Parameters in Egyptian Patients with RRMS: A Pilot Study, German University in Cairo) — Principal investigator
First posted
Feb 6, 2025
Start date
Apr 1, 2022
Primary completion
May 30, 2023
Completion
Jan 30, 2025
Last update
Feb 6, 2025

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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This study is completed, as verified in Apr 2022. You cannot join it, but the record below documents what was studied.

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Studies of the drug tested here: Metformin

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