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

Phase 2

Completed

• Conditions: Multiple Sclerosis (MS) - Relapsing-remitting
• Interventions: Other: Usual Care; Drug: Metformin (Cidophage®)

• Registration Number: NCT06812585
• Lead Sponsor: German University in Cairo

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2022-04
• Study Start: 2022-04-01
• Primary Completion: 2023-05-30
• Study Completion: 2025-01-30
• Study First Submitted: 2025-02-02
• Study First Submitted QC: 2025-02-02
• Last Update Submitted: 2025-02-02
• Study First Posted: 2025-02-06
• Last Update Posted: 2025-02-06

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control group	Usual Care	Active Comparator: Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®)
Intervention group	Metformin (Cidophage®)	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 ®).

Primary Outcome Measures

Name	Time	Method
Change in serum levels of neurofilament light chain in both arms	After 6 months

Secondary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Nasser Institute for Research and Treatment; 🇪🇬 Cairo, Egypt