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

NCT ID: NCT06812585

Last Updated: 2025-02-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-04-01

Study Completion Date

2025-01-30

Brief Summary

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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

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Conditions

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Multiple Sclerosis (MS) - Relapsing-remitting

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Control group

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

Group Type ACTIVE_COMPARATOR

Usual Care

Intervention Type OTHER

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

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 ®).

Group Type EXPERIMENTAL

Metformin (Cidophage®)

Intervention Type DRUG

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

Interventions

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Metformin (Cidophage®)

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

Intervention Type DRUG

Usual Care

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

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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German University in Cairo

OTHER

Sponsor Role lead

Responsible Party

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Mohamed Youssef Elsayed

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

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Nasser Institute for Research and Treatment

Cairo, Cairo Governorate, Egypt

Site Status

Countries

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Egypt

Other Identifiers

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MET in sNFL and NFK-B

Identifier Type: -

Identifier Source: org_study_id

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