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

NCT06812585 | Completed Phase 2 DMC

• 1 other identifier: MET in sNFL and NFK-B
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Multiple Sclerosis (MS) - Relapsing-remitting

Outcome Measures

Primary Outcomes (1)

• Change in serum levels of neurofilament light chain in both arms

  After 6 months

Secondary Outcomes (3)

• Change in serum levels of nuclear factor kappa B in both arms

  After 6 months

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

  After 6 months

• Degree of disability assessed by Expanded Disability Status Scale.

  After 6 months

Study Arms (2)

Control group

ACTIVE COMPARATOR

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

Other: Usual Care

Intervention group

EXPERIMENTAL

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

Metformin (Cidophage®) DRUG

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

Intervention group

Usual Care OTHER

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

Control group

Eligibility Criteria

• Age: 18 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• German University in Cairo: lead

Study Sites (1)

Nasser Institute for Research and Treatment

Cairo, Cairo Governorate, 1053, Egypt

Location

Related Publications (1)

• 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.

  PMID: 41483718 DERIVED

MeSH Terms

Conditions

Multiple Sclerosis, Relapsing-Remitting

Interventions

Metformin

Condition Hierarchy (Ancestors)

Multiple Sclerosis; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: The Effect of Metformin as an Adjuvant Therapy on Immunological Parameters in Egyptian Patients with RRMS: A Pilot Study

Study Record Dates

• First Submitted: February 2, 2025
• First Posted: February 6, 2025
• Study Start: April 1, 2022
• Primary Completion: May 30, 2023
• Study Completion: January 30, 2025
• Last Updated: February 6, 2025

Record last verified: 2022-04

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)