Drug Repurposing for Improving the Therapeutic Outcome in Multiple Sclerosis Patients

• Status: Not yet recruiting
• Trial end date: 2023-03-28
• Target enrollment: 0
• Participant gender: All

Summary

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

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: German University in Cairo
• Treatments: Interferon beta-1a; Interferon-beta; Interferons; Metformin

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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.