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

German University in Cairo

Status and phase: Completed; Phase 2

Conditions: Multiple Sclerosis (MS) - Relapsing-remitting

Treatments: Drug: Metformin (Cidophage®); Other: Usual Care

Study type: Interventional

Funder types: Other

Identifiers

NCT06812585

MET in sNFL and NFK-B

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Control group

Active Comparator group

Description:

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

Treatment:

Other: Usual Care

Intervention group

Experimental group

Description:

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 ®).

Treatment:

Drug: Metformin (Cidophage®)