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NOT YET RECRUITING
NCT07272967
PHASE4

Metformin in Preventing Secondary Gliosis Following Acute Thoraco-Lumbar Spinal Cord Injury

Sponsor: Badr University

View on ClinicalTrials.gov

Summary

Background: Spinal cord injury (SCI) is a major global health problem, with thoraco-lumbar injuries often leading to paraplegia and incomplete neurological recovery. The glial scar, resulting from astrocyte activation at the injury site, constitutes a major barrier to axon regeneration. Given the limitations of current treatments, there is an urgent need for new interventions to improve outcomes. Metformin, a common drug for diabetes, shows promising potential as a neuroprotective agent in preclinical SCI models, where it improves motor function and reduces pain and glial scar formation. Its safety in acute neurological injury has also been supported in a recent human trial for severe traumatic brain injury. Objective: To test the safety and efficacy of metformin in acute thoraco-lumbar SCI, focusing on neurological and functional outcomes as well as DTI metrics of spinal cord integrity. Methods. Study Design. Randomized, double-blinded, placebo-controlled study. Population: Participants that will be admitted during the time of the study to Neurosurgery department at Menoufia University hospitals at Menoufia University. Setting: Neurosurgery department at Menoufia University hospitals at Menoufia University. Keywords: Metformin, spinal cord injury, gliosis, randomized controlled trial, neuroprotection

Official title: Safety and Efficacy of Metformin in Preventing Secondary Gliosis Following Acute Thoraco-Lumbar Spinal Cord Injury: A Randomized, Double-Blinded, Placebo-Controlled Study.

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

34

Start Date

2026-01-01

Completion Date

2026-02-01

Last Updated

2025-12-09

Healthy Volunteers

No

Interventions

DRUG

Metformin

Participants assigned to the metformin group will receive 1,000 mg of immediate-release metformin orally, twice daily

DRUG

Placebo

Participants in the placebo group will receive an identical-appearing placebo, administered orally, twice daily

Locations (1)

Neurosurgery department at Menoufia University hospitals at Menoufia University.

Shibīn al Kawm, Menoufia, Egypt