Multiple Sclerosis (MS) - Relapsing-remitting
Conditions
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.
Interventions
DRUGMetformin (Cidophage®)
Antidiabetic agent used to treat type 2 diabetes, and to prevent type 2 diabetes.
OTHERUsual Care
Active Comparator: Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®) Interferon beta 1 a (Rebiff ® 44mcg or Avonex ®)
Sponsors
German University in Cairo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in serum levels of neurofilament light chain in both arms | After 6 months |
Secondary
| Measure | Time frame |
|---|---|
| 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 |
Countries
Egypt
Outcome results
None listed