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

NCT07272967 | Not Yet Recruiting Phase 4

• 1 other identifier: 9/2025NEUS6
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Metformin; spinal cord injury,; gliosis; , randomized controlled trial; neuroprotection

Outcome Measures

Primary Outcomes (1)

• Neurological recovery

  Comparison of postoperative American Spinal Injury Association (ASIA) Impairment Scale grade ranging from A to E where Grade A= Complete spinal cord injury and Grade E=Normal function

  2 weeks, and 3-months postoperatively.

Secondary Outcomes (2)

• Pain intensity

  at 2 weeks, and 3-months postoperatively

• Neuropathic Pain character

  at 2 weeks, and 3-months postoperatively

Study Arms (2)

Metformin

ACTIVE COMPARATOR

The metformin group will receive 1,000 mg of immediate-release metformin orally, twice daily

Drug: Metformin

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo

Interventions

Metformin DRUG

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

Also known as: Glucophage 1000 mg tablets

Metformin

Placebo DRUG

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

Also known as: Metformin free tablets

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Adults aged 18-65 years, who had acute, non-penetrating thoraco-lumbar SCI (T1-conus medullaris), with new neurological deficits.
• Injury occurred within the past 24 hours before enrollment.
• American Spinal Injury Association (ASIA) Impairment Scale grade B-D.
• Able to undergo MRI of the spine.
• Informed consent provided by patient or legal representative.

You may not qualify if:

• Major spinal transaction or cervical spinal cord injury.
• Prior spinal surgery or pre-existing spinal pathology (e.g., kyphosis, tumors).
• Concomitant severe traumatic brain injury (Glasgow Coma Scale \< 13) or other CNS injury that would confound neurological assessment.
• Known diabetes mellitus (type 1 or 2) or current use of metformin.
• Penetrating spinal injury (e.g. gunshot, stab wound).
• Implanted metallic devices or conditions precluding MRI.
• Pregnancy or breastfeeding.
• Severe comorbidities (e.g. end-stage liver disease, renal failure with eGFR\<30 mL/min).
• Known allergy to metformin.
• Uncontrolled infection or sepsis at presentation.

Sponsors & Collaborators

• Badr University: lead

Study Sites (1)

Neurosurgery department at Menoufia University hospitals at Menoufia University.

Shibīn al Kawm, Menoufia, 32817, Egypt

Location

MeSH Terms

Conditions

Spinal Cord Injuries; Gliosis

Interventions

Metformin

Condition Hierarchy (Ancestors)

Spinal Cord Diseases; Central Nervous System Diseases; Nervous System Diseases; Trauma, Nervous System; Wounds and Injuries; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Biguanides; Guanidines; Amidines; Organic Chemicals

Central Study Contacts

Eman Swan, PHD

CONTACT

+201090111013; eman.said@buc.edu.eg

Saeed Alemam, PHD

CONTACT

+201027345368; Said.elemam@med.menofia.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Clinical Pharmacy, Faculty of Pharmacy

Study Record Dates

• First Submitted: November 19, 2025
• First Posted: December 9, 2025
• Study Start: January 1, 2026
• Primary Completion: January 1, 2026
• Study Completion: February 1, 2026
• Last Updated: December 9, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)