Acute Spinal Cord InjuryPhase 1SCINGNCT05426681
Spinal Cord Injury Neuroprotection With Glyburide
A Phase 1 study testing GlyBURIDE Oral Tablet in people with Acute Spinal Cord Injury, run by Francis Farhadi at 1 site in United States.
Trial summary
To assess the safety and efficacy of using oral Glyburide (Diabeta) as a neuroprotective agent in patients with acute cervical or thoracic traumatic spinal cord injury. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Acute Spinal Cord Injury
- What is being tested?
- GlyBURIDE Oral Tablet
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 12 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Jul 2022to May 2028
- Phase
- Phase 1
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- No life threatening injuries resulting from the traumatic accident
- No evidence of sepsis
- Acute cervical or thoracic SCI with ASIA Impairment Scale Grade A, B, or C od admission.
- Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12
Who cannot join
- Unconsciousness or other mental impairment that prevents neurological assessment within the first 8 hours
- Acute SCI with ASIA Impairment Scale grade D or E
- Currently involved in another non-observational SCI research study or receiving another investigational drug
- History of hypersensitivity to sulfonylureas, in particular glyburide, or any of its components
- Any condition likely to result in the patient's death within the next 12 months
- Severe renal disorder from the patient's history (e.g. dialysis) or baseline eGFR of < 30 mL/min/1.73 m2
Show all 10Show fewer
- Known severe liver disease, or ALT > 3 times upper limit of normal or bilirubin
- Blood glucose <55 mg/dL at enrollment or immediately prior to administration of DiaBeta, or a clinically significant history of hypoglycemia
- Acute ST elevation myocardial infarction, and/or acute decompensated heart failure, and/or QTc > 520 ms, and/or known history of cardiac arrest (PEA, VT, VF, asystole), and/or admission for an acute coronary syndrome, myocardial infarction, or coronary intervention (percutaneous coronary intervention or coronary artery surgery) within the past 3 months
- Known G6PD enzyme deficiency
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
University of Kentucky
Lexington, Kentucky, 40536
Francis Farhadi, MD, PhD, 859-562-0247, francis.farhadi@uky.edu
Harshit Arora, PhD, 859-323-4533, harshit.arora@uky.edu
About this study
Official title: Spinal Cord Injury Neuroprotection With Glyburide (SCING): Pilot Study: An Open-Label Prospective Evaluation of the Feasibility, Safety, Pharmacokinetics, and Preliminary Efficacy of Oral Glyburide (DiaBeta) in Patients With Acute Traumatic Spinal Cord Injury
To assess the safety and efficacy of using oral Glyburide (Diabeta) as a neuroprotective agent in patients with acute cervical or thoracic traumatic spinal cord injury.
Read the detailed description
This study will include subjects between 18 and 80 years who have experienced acute traumatic cervical or thoracic spinal cord injury. Subjects will begin an oral drug regimen of Glyburide with the initial dose being within 8 hours of the injury and again every 6 hours after for 72 total hours of treatment. The daily dose of 3.125mg on day one and 2.5 mg on days 2 and 3 will be used to determine if the investigational drug provides any neuroprotection when given soon after injury. If indicated, the subject will also have surgical intervention for spinal cord decompression surgery and spinal stabilization. Participants will have labs drawn regularly, and ECGs done throughout their hospital stay. Adverse events will be monitored daily through day 14 of participation or hospital discharge (whichever is earlier). Study participation will last for 365 days (+/- 30 days), with post-hospitalization follow-up occurring on days 28, 42, 84, 182, and 365.
- Conditions
- Acute Spinal Cord Injury
- Being tested
- GlyBURIDE Oral Tablet
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GlyBURIDE Oral TabletDrug
Also called Diabeta
Enrolled patients will receive 12 doses of Glyburide starting within 8 hours of spinal cord injury. The dosing regimen involves an initial dose of 1.25mg followed by 11 consecutive doses of 0.625 mg every 6 hours. The total daily dose of Glyburide on Day 1, Day 2, and Day 3 will be 3.125 mg, 2.5 mg, and 2.5 mg respectively.
Intervention: Drug: Glyburide
| Study group | Role | What they receive |
|---|---|---|
| Glyburide treatment arm | Experimental | Not described Receives: Drug: GlyBURIDE Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of recruitment of patients with tSCI within the specified time window.
A measure of feasibility of undertaking a large phase II study among this population of patients where treatment must begin within a short injury-to-drug time window.
Measured: within 8 hours of tSCI
Number of drug related adverse events.
A measure of safety of treating patients with traumatic spinal cord injury with Glyburide administered orally.
Measured: One year post treatment
Secondary outcomes (3)
Neurologic recovery following tSCI
Neurologic status be assessed using the American Spinal Injury Association Impairment Scale. This neurological exam assesses sensory and motor impairments using touch and pin prick evaluations in each dermatome and muscle strength. Right and left body sides are evaluated independently. Lower the scores indicate greater degree of impairment.
Touch and pin prick perception is scored using a 0-2 and NT grade. Where 0= Absent, 1= hypo/hypersensitivity, 2= normal sensation, and NT= not testable. Scores for each body side are added together and summed for a total sensation score. Maximum score possible for this section is 112 per side.
Muscle function is rated on a 0-5 scale. Where 0= total paralysis, 1= palpable/visible contraction, 2= active movement, full ROM with gravity eliminated, 3= active movement, full ROM against gravity, 4= active movement, full ROM with moderate resistance, 5= Normal movement and strength, and NT= not tested. Maximum score for this section is 50 per side.
Measured: One year post enrollment.
Serum Pharmacokinetics to measure Glyburide concentrations.
Plasma concentrations of Glyburide will be serially quantified through day 3 following tSCI to evaluate the pharmacokinetics of the investigational drug. Comparisons will be made to reported levels achieved in healthy patient cohorts.
Measured: Enrollment through post-treatment day 7.
Biomarker Analysis
Standard enzyme-linked immunosorbent assay (ELISA) techniques will be used to measure blood levels of neurofilament light chain, neuron- specific enolase, tau, S100b, and glial fibrillary acidic protein levels on admission, at 24 hours and on days 3 and 7 following tSCI to evaluate serum biomarker levels. Comparisons will be made to previously published values observed in non-treated control patients
Measured: Enrollment, Day 3, and Day 7
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2022
- Study start7 Jul 2022
- Primary completionMay 2027 (estimated)
- Study completionMay 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Spinal Cord InjuryStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 12 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Francis Farhadi
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Francis Farhadi, University of Kentucky
- Investigators
- Francis Farhadi, MD, PhD, Principal investigator, University of Kentucky
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05426681
- Sponsor's protocol ID
- 77662
- Acronym
- SCING
- Status last verified
- Feb 2026
- First submitted
- 13 Jun 2022
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Spinal Cord Injury Neuroprotection With Glyburide (SCING): Pilot Study: An Open-Label Prospective Evaluation of the Feasibility, Safety, Pharmacokinetics, and Preliminary Efficacy of Oral Glyburide (DiaBeta) in Patients With Acute Traumatic Spinal Cord Injury
- ClinicalTrials.gov ID
- NCT05426681
- Acronym / sponsor ID
- SCING / 77662
- Conditions
- Acute Spinal Cord Injury
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 12 participants (estimated)
- Lead sponsor
- Francis FarhadiUniversity, hospital or other
- Study start
- 7 Jul 2022 (actual)
- Primary completion
- May 2027 (estimated)
- Study completion
- May 2028 (estimated)
- First posted
- 22 Jun 2022 (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.
To assess the safety and efficacy of using oral Glyburide (Diabeta) as a neuroprotective agent in patients with acute cervical or thoracic traumatic spinal cord injury.
Detailed description
This study will include subjects between 18 and 80 years who have experienced acute traumatic cervical or thoracic spinal cord injury. Subjects will begin an oral drug regimen of Glyburide with the initial dose being within 8 hours of the injury and again every 6 hours after for 72 total hours of treatment. The daily dose of 3.125mg on day one and 2.5 mg on days 2 and 3 will be used to determine if the investigational drug provides any neuroprotection when given soon after injury. If indicated, the subject will also have surgical intervention for spinal cord decompression surgery and spinal stabilization. Participants will have labs drawn regularly, and ECGs done throughout their hospital stay. Adverse events will be monitored daily through day 14 of participation or hospital discharge (whichever is earlier). Study participation will last for 365 days (+/- 30 days), with post-hospitalization follow-up occurring on days 28, 42, 84, 182, and 365.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Glyburide treatment arm | Experimental | Drug: GlyBURIDE Oral Tablet |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- No life threatening injuries resulting from the traumatic accident
- No evidence of sepsis
- Acute cervical or thoracic SCI with ASIA Impairment Scale Grade A, B, or C od admission.
- Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12
Key exclusion criteria (10 listed)
- Unconsciousness or other mental impairment that prevents neurological assessment within the first 8 hours
- Acute SCI with ASIA Impairment Scale grade D or E
- Currently involved in another non-observational SCI research study or receiving another investigational drug
- History of hypersensitivity to sulfonylureas, in particular glyburide, or any of its components
- Any condition likely to result in the patient's death within the next 12 months
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 |
|---|---|---|
| GlyBURIDE Oral TabletAlso: DiabetaEnrolled patients will receive 12 doses of Glyburide starting within 8 hours of spinal cord injury. The dosing regimen involves an initial dose of 1.25mg followed by 11 consecutive doses of 0.625 mg every 6 hours. The total daily dose of Glyburide on Day 1, Day 2, and Day 3 will be 3.125 mg, 2.5 mg, and 2.5 mg respectively. Intervention: Drug: Glyburide | Drug | Glyburide treatment arm |
Primary outcome
Rate of recruitment of patients with tSCI within the specified time window.
Time frame: within 8 hours of tSCI
A measure of feasibility of undertaking a large phase II study among this population of patients where treatment must begin within a short injury-to-drug time window.
Number of drug related adverse events.
Time frame: One year post treatment
A measure of safety of treating patients with traumatic spinal cord injury with Glyburide administered orally.
3 secondary outcomes
Neurologic recovery following tSCI
Time frame: One year post enrollment.
Serum Pharmacokinetics to measure Glyburide concentrations.
Time frame: Enrollment through post-treatment day 7.
Biomarker Analysis
Time frame: Enrollment, Day 3, and Day 7
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 13 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Francis Farhadi, MD, PhD principal investigator
University of Kentucky
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GlyBURIDE Oral Tablet in people with Acute Spinal Cord Injury, run by Francis Farhadi at 1 site in United States.
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 4 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: looking for participants now, as of the sponsor's last update on 13 Feb 2026. 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 United States. 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. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 H. Francis Farhadi, MD, PhD (859-323-5661, francis.farhadi@uky.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of recruitment of patients with tSCI within the specified time window. (time frame: within 8 hours of tSCI). The study lists 2 primary outcomes in all. 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 13 Feb 2026.