Status:
UNKNOWN
Drug Repurposing Using Metformin for Improving the Therapeutic Outcome in Multiple Sclerosis Patients
Lead Sponsor:
German University in Cairo
Conditions:
Multiple Sclerosis
Eligibility:
All Genders
18-50 years
Phase:
PHASE2
Brief 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 abou...
Eligibility Criteria
Inclusion
- Age between 18 and 50 years at time of signing informed consent form.
- Relapsing- remitting multiple sclerosis as per the McDonald 2017 criteria, including an MRI brain satisfying the 2017 radiological criteria.
- Full-field visual evoked potential (VEP) P100 latency in at least one eye of ≥118 ms.
- Kurtzke EDSS step 0.0 - 6.0.
- At the time of screening, being treated with a stable dose for at least 6 months of a category 1 multiple sclerosis DMT or for at least 2 years with a category 2 DMT.
Exclusion
- People taking medication for Diabetes Mellitus at screening.
- Female participants who are pregnant, lactating, planning pregnancy, or unwilling to use reliable contraception during the trial.
- Significant liver impairment; alanine aminotransferase \> 3 times the upper limit of normal.
- People suffering from congestive heart failure, chronic lung disease with hypoxia, and severe anemia.
- Patients with compromised renal function ((eGFR \<60 mL/min/1.73m2) or coexistent hypoxic conditions should not be given metformin.
- Chronic or acute intake of large amounts of alcohol may potentiate the effect of metformin on lactate metabolism.
- Patients had been prescribed oral, intravenous, and intramuscular corticosteroids for one month prior to study.
Key Trial Info
Start Date :
February 1 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 28 2023
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT05298670
Start Date
February 1 2022
End Date
March 28 2023
Last Update
March 20 2023
Active Locations (1)
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1
Nasser Institute for Research and Treatment
Cairo, Egypt