Spinal Cord Injury (SCI)Phase 4NCT07272967
Metformin in Preventing Secondary Gliosis Following Acute Thoraco-Lumbar Spinal Cord Injury
A Phase 4 study testing Metformin in people with Spinal Cord Injury (SCI), run by Badr University at 1 site in Egypt.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Spinal Cord Injury (SCI)
- What is being tested?
- Metformin
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jan 2026to 1 Feb 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Neurosurgery department at Menoufia University hospitals at Menoufia University.
Shibīn al Kawm, Menoufia, 32817
Said Elemam, PHD, +201027345368, Said.elemam@med.menofia.edu.eg
About this study
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.
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.
Read more
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
Read the 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)
- Being tested
- Metformin, Placebo
- Keywords
- Metformin, spinal cord injury,, gliosis, , randomized controlled trial, neuroprotection
- Medical subject headings
- Spinal Cord Injuries, Gliosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MetforminDrug
Also called Glucophage 1000 mg tablets
Participants assigned to the metformin group will receive 1,000 mg of immediate-release metformin orally, twice daily
PlaceboDrug
Also called Metformin free tablets
Participants in the placebo group will receive an identical-appearing placebo, administered orally, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Metformin | Active comparator | The metformin group will receive 1,000 mg of immediate-release metformin orally, twice daily Receives: Drug: Metformin |
| Placebo | Placebo comparator | Participants in the placebo group will receive an identical-appearing placebo, administered orally, twice daily Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 2 weeks, and 3-months postoperatively.
Secondary outcomes (2)
Pain intensity
Comparison of postoperative patient-reported pain using Visual Analog Scale (VAS) that is ranging from 0-10 score where 0=no pain and10= the worst possible pain
Measured: at 2 weeks, and 3-months postoperatively
Neuropathic Pain character
Comparison of postoperative Neuropathic character of pain using Neuropathic Pain Symptom Inventory (NPSI) scale ranging from 0-10 score where 0=no pain and 10= the worst possible pain
Measured: at 2 weeks, and 3-months postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2025
- Study start1 Jan 2026 (estimated)
- Primary completion1 Jan 2026 (estimated)
- Study completion1 Feb 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Spinal Cord Injury (SCI)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 34 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Badr University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eman Said Sawan, Badr University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07272967
- Sponsor's protocol ID
- 9/2025NEUS6
- Status last verified
- Nov 2025
- First submitted
- 19 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Data is available with corresponding author on reasonable request
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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.
- ClinicalTrials.gov ID
- NCT07272967
- Acronym / sponsor ID
- 9/2025NEUS6
- Conditions
- Spinal Cord Injury (SCI)
- Keywords
- Metformin, spinal cord injury,, gliosis, , randomized controlled trial, neuroprotection
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 34 participants (estimated)
- Lead sponsor
- Badr UniversityUniversity, hospital or other
- Study start
- 1 Jan 2026 (estimated)
- Primary completion
- 1 Jan 2026 (estimated)
- Study completion
- 1 Feb 2026 (estimated)
- First posted
- 9 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Metformin | Active comparator | Drug: MetforminThe metformin group will receive 1,000 mg of immediate-release metformin orally, twice daily |
| Placebo | Placebo comparator | Drug: PlaceboParticipants in the placebo group will receive an identical-appearing placebo, administered orally, twice daily |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (10 listed)
- 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).
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MetforminAlso: Glucophage 1000 mg tabletsParticipants assigned to the metformin group will receive 1,000 mg of immediate-release metformin orally, twice daily | Drug | Metformin |
| PlaceboAlso: Metformin free tabletsParticipants in the placebo group will receive an identical-appearing placebo, administered orally, twice daily | Drug | Placebo |
Primary outcome
Neurological recovery
Time frame: 2 weeks, and 3-months postoperatively.
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 secondary outcomes
Pain intensity
Time frame: at 2 weeks, and 3-months postoperatively
Neuropathic Pain character
Time frame: at 2 weeks, and 3-months postoperatively
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Individual participant dataSharing planned: No. Data is available with corresponding author on reasonable request
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Metformin in people with Spinal Cord Injury (SCI), run by Badr University at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Eman Swan, PHD (+201090111013, eman.said@buc.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Neurological recovery (time frame: 2 weeks, and 3-months postoperatively.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.