The Effect of Metformin As an Adjuvant Therapy on Immunological Parameters in Egyptian Patients with RRMS: a Pilot Study
What it found
The main measure did not show a significant benefit.
“There were no statistically significant differences between the two groups in the change in the median (interquartile range) of the blood biomarkers (sNFL; -32.8 (21) vs -32.8 (13.4), p = 0.99) and NF-κB; -64.9 (35.1) vs -61.6 (35.7), p = 0.8, respectively).”Read by software from the paper's abstract
6 months
| Group | n | Value |
|---|---|---|
| IFNβ-1a alone | -32.8 (13.4) |
p = 0.99
Read by software from the paper's abstract
What was tested
Treatment tested
- Metformin
Compared with
- Usual Care
What it measured
Main measures
Change in serum levels of neurofilament light chain in both arms
After 6 months
Blood or spinal fluid markers
Other measures (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
MRI lesionsMyelin repairDegree of disability assessed by Expanded Disability Status Scale.
After 6 months
Disability progression
Who could take part
Relapsing MS · 18 to 50
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.
As registered. Criteria can change, so ask the trial team or your neurologist.
About this trial
In the sponsor's words
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.
Papers
Results
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
There were no statistically significant differences between the two groups in the change in the median (interquartile range) of the blood biomarkers (sNFL; -32.8 (21) vs -32.8 (13.4), p = 0.99) and NF-κB; -64.9 (35.1) vs -61.6 (35.7), p = 0.8, respectively).
Read by software from the paper's abstract
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History
Started
Apr 2022
Main results due
May 2023
Finished
Jan 2025
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