Phase I Double Blind Study of Metformin Effects on Neural Cells in Children and Young Adults with Multiple Sclerosis

What this Trial Is About

Researchers are evaluating the use of metformin in children and young adults aged 10 to 25 years with multiple sclerosis MS who have involvement of the anterior visual pathway. This randomized, phase 1 and 2 double-blind trial aims to study how metformin affects endogenous neural progenitor cells in this group. The study is designed to assess safety, tolerability, recruitment, retention, and adherence over a 12-month period. Participants will be randomly assigned to one of three groups that start metformin treatment at different times during the 12 months at 3 months, 6 months, or 9 months. Each participant will take metformin daily for at least 3 months and up to 9 months. The dosing starts at 500 mg per square meter per day, increasing to 1000 mg per square meter per day as tolerated, with a maximum of 2000 mg daily. Placebo tablets are given during periods before starting metformin depending on the group assignment. Throughout the study, participants will have regular visits to monitor safety and treatment effects, including eye imaging tests like Optical Coherence Tomography OCT and Visual Evoked Potentials VEP to assess the optic nerve and retinal nerve fiber layer. Researchers will track adverse events, participation rates, and completion of study measures. The study aims to complete data collection within three years, ensuring careful monitoring of participants health and adherence to the protocol.

A Phase I Double Blind Study of Metformin Acting on Endogenous Neural Progenitor Cells in Children and Young Adults With Multiple Sclerosis