NCT05298670

Drug Repurposing Using Metformin for Improving the Therapeutic Outcome in Multiple Sclerosis Patients

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 80 (estimated)
• Sponsor: German University in Cairo · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Not accepted

Summary

This study aims to evaluate the effect of Metformin as add- on therapy for improving the outcome in RRMS patients.

Detailed description

Multiple sclerosis (MS) is an autoimmune-mediated neurodegenerative disease of the central nervous system characterized by inflammatory demyelination with axonal transection. Worldwide, there are about 2.3 million MS patients. Women are twice as likely to have MS as men. MS typically presents in young adults (mean age of onset, 20-30 years) and can lead to physical disability, cognitive impairment, and decreased quality of life. The four main types of multiple sclerosis are clinically isolated syndrome (CIS), relapsing-remitting MS (RRMS), secondary progressive MS (SPMS), and primary progressive MS (PPMS). This research focuses on RRMS as it is the most common type (80%- 85%). Elevated level of Interleukins, and oxidative stress parameters are associated with MS pathology which exaggerated the myelin destruction, axonal degradation, and inflammatory cascade. Metformin has a global safety record, is well-tolerated by the majority of patients and is used by roughly 125 million people worldwide, so a lot of studies inside and outside Egypt investigates their potential effect in different disorders as neurodegenerative diseases and cancer. Despite the prevalence of animal studies which explored Metformin neuroprotective effects by decreasing T- helper cells (Th 1 and Th 17) and improving Oligodendrocyte progenitor cell responsiveness to induce remyelination, clinical trials are still insufficient which motivate us to investigate the promising effect of Metformin as add-on treatment in RRMS patients

Conditions

• Multiple Sclerosis

Interventions

Type	Name	Description
DRUG	MetFORMIN 1000 Mg Oral Tablet	Antidiabetic agent used to treat type 2 diabetes, and to prevent type 2 diabetes.
DRUG	Interferon beta-1a	Disease Modifying Therapies (DMTs)

Timeline

• Start date: 2022-02-01
• Primary completion: 2023-02-28
• Completion: 2023-03-28
• First posted: 2022-03-28
• Last updated: 2023-03-20

Locations

1 site across 1 country: Egypt