NCT07272967

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

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

• Status: Not Yet Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 34 (estimated)
• Sponsor: Badr University · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

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

Detailed description

Study Design. Randomized, double-blinded, placebo-controlled study. Randomization and Blinding. Participants will be randomly assigned to either the metformin or placebo group in a 1:1 ratio using block randomization. A computer-generated randomization sequence will be created with the R software (version 4.4.1) and the blockrand package(7). This sequence will be securely stored and accessible only to the study statistician. Treatment packets will be pre-labeled with unique numbers matching the randomization sequence. When a patient qualifies for the study, they will receive a numbered packet corresponding to their assignment. To ensure objectivity, neither participants nor study staff will know which number corresponds to metformin or placebo-only the statistician will have access to this information. Setting: Neurosurgery department at Menoufia University hospitals at Menoufia University. Instruments: We will assess the patient using AISA grade, Visual Analog Scale (VAS) and the Neuropathic Pain Symptom Inventory (NPSI) (8-10). Data collection: It will be done by data collaborators under the leadership of the investigators in: Neurosurgery department at Menoufia University hospitals at Menoufia University.

Conditions

• Spinal Cord Injury (SCI)

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-01-01
• Primary completion: 2026-01-01
• Completion: 2026-02-01
• First posted: 2025-12-09
• Last updated: 2025-12-09

Locations

1 site across 1 country: Egypt