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

NCT07272967 · Status: NOT_YET_RECRUITING · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 34

Last updated 2025-12-09

No results posted yet for this study

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

Conditions

  • Spinal Cord Injury (SCI)

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

Sponsors & Collaborators

  • Badr University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-01-01
Primary Completion
2026-01-01
Completion
2026-02-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07272967 on ClinicalTrials.gov