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

NCT ID: NCT07272967

Last Updated: 2025-12-09

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: PHASE4
• Total Enrollment: 34 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2026-01-01
• Study Completion Date: 2026-02-01

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

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)

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Metformin

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

Group Type: ACTIVE_COMPARATOR

Metformin

Intervention Type: DRUG

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

Placebo

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

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DRUG

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

Interventions

Metformin

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

Intervention Type: DRUG

Placebo

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

Intervention Type: DRUG

Other Intervention Names

Glucophage 1000 mg tablets; Metformin free tablets

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Badr University

OTHER

Sponsor Role: lead

Responsible Party

Eman Said Sawan

Lecturer of Clinical Pharmacy, Faculty of Pharmacy

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Neurosurgery department at Menoufia University hospitals at Menoufia University.

Shibīn al Kawm, Menoufia, Egypt

Countries

Egypt

Central Contacts

Eman Swan, PHD

Role: CONTACT

eman.said@buc.edu.eg

+201090111013

Saeed Alemam, PHD

Role: CONTACT

Said.elemam@med.menofia.edu.eg

+201027345368

Facility Contacts

Said Elemam, PHD

Role: primary

Said.elemam@med.menofia.edu.eg

+201027345368

Other Identifiers

9/2025NEUS6

Identifier Type: -

Identifier Source: org_study_id