A Phase 1/2 interventional study of Glyburide in Acute Spinal Cord Injury, sponsored by Ohio State University. Terminated at 1 site in United States. Open to participants aged 18 Years to 80 Years. Per ClinicalTrials.gov, last updated 2022-07-05.
Sponsored by Ohio State University · Phase 1/2, Interventional, and Treatment
The purpose of this study is to determine the safety of using oral Glyburide in patients with acute traumatic cervical spinal cord injuries (SCI).
This study will include patients between 18 and 80 years who have experienced acute traumatic cervical spinal cord injury (specifically ASIA A, B or C). Patients will then begin an oral drug regimen of Glyburide, which must be started within 8 hours of injury and continued for 72 hours at a daily dose of 3.125 mg on Day 1, 2.5 mg on Day 2 and 2.5 mg on Day 3. If indicated, the patient will also have surgical intervention for spinal cord decompression and spinal stabilization. Each patient who takes part in this study will have labs drawn regularly and adverse events assessed daily through Day 14 or 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.
Ohio State University is the lead sponsor of 658 studies on the registry; 145 are open to participants now.
Of its 66 completed or terminated interventional studies of FDA-regulated products, 49 (74%) have results posted.
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Exclusion Criteria
Enrolled patients will receive 12 doses of Glyburide starting within 8 hours of SCI. The dosing regimen involves an initial dose of 1.25 mg followed by eleven 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.
Drug: Glyburide
3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.
Number of Participants With tSCI Recruited Within the Specified Time Window
A measure of feasibility of undertaking a larger phase II study among this population of patients where treatment must begin within a short injury-to-drug time window.
Time frame: Enrollment Period (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 within a short injury-to-drug time window.
Time frame: One year post enrollment
Number of Participants With Neurologic Recovery Following tSCI
The neurologic status of patients will be assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS) as assessed by International Standards for Neurological Classification of SCI (ISNCSCI) criteria.
Time frame: One year post enrollment
Serum Pharmacokinetic and Biomarker Analysis
Plasma concentrations will be serially quantified through day 3 following tSCI to evaluate the pharmacokinetics of Glyburide in the acute tSCI population. Comparisons will be made to reported levels achieved in healthy patient cohorts. 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
Time frame: Enrollment through post-treatment day 7
| Milestone | Glyburide Treatment Arm |
|---|---|
| Started | 3 |
| Completed | 2 |
| Not completed | 1 |
| Withdrew: Death | 1 |
A measure of feasibility of undertaking a larger phase II study among this population of patients where treatment must begin within a short injury-to-drug time window.
| Participants | Glyburide Treatment Arm |
|---|---|
| Number of Participants With tSCI Recruited Within the Specified Time Window | 3 |
A measure of safety of treating patients with traumatic spinal cord injury with Glyburide administered orally within a short injury-to-drug time window.
| Events | Glyburide Treatment Arm |
|---|---|
| Number of Drug Related Adverse Events | 0 |
The neurologic status of patients will be assessed using the American Spinal Injury Association (ASIA) Impairment Scale (AIS) as assessed by International Standards for Neurological Classification of SCI (ISNCSCI) criteria.
| Participants | Glyburide Treatment Arm |
|---|---|
| Number of Participants With Neurologic Recovery Following tSCI | 2 |
Plasma concentrations will be serially quantified through day 3 following tSCI to evaluate the pharmacokinetics of Glyburide in the acute tSCI population. Comparisons will be made to reported levels achieved in healthy patient cohorts. 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
No measurements were reported for this outcome.
Collected over 1 year. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Glyburide Treatment Arm | 1/3 (33.3%) | 2/3 (66.7%) | 1/3 (33.3%) |
| Event | Glyburide Treatment Arm |
|---|---|
| BradycardiaCardiac disorders | 1/3 |
| Other Dysrhythmia (Tachy-brady syndrome)Cardiac disorders | 1/3 |
| Acute Renal FailureGastrointestinal disorders | 1/3 |
| Acute respiratory distress syndrome (ARDS) - AtelecetasisRespiratory, thoracic and mediastinal disorders | 1/3 |
| Event | Glyburide Treatment Arm |
|---|---|
| ThromocytopeniaBlood and lymphatic system disorders | 1/3 |
| AnemiaBlood and lymphatic system disorders | 1/3 |
| Urinary Tract Infection (UTI)Infections and infestations | 1/3 |
| HypoglycemiaMetabolism and nutrition disorders | 1/3 |
| Age, Categorical(Participants) | Glyburide Treatment Arm |
|---|---|
| <=18 years | 0 |
| Between 18 and 65 years | 2 |
| >=65 years | 1 |
| Age, Continuous(years) | Glyburide Treatment Arm |
|---|---|
| Mean | 57 ± 10.03 |
| Sex: Female, Male(Participants) | Glyburide Treatment Arm |
|---|---|
| Female | 1 |
| Male | 2 |
| Ethnicity (NIH/OMB)(Participants) | Glyburide Treatment Arm |
|---|---|
| Hispanic or Latino | 0 |
| Not Hispanic or Latino | 3 |
| Unknown or Not Reported | 0 |
| Race (NIH/OMB)(Participants) | Glyburide Treatment Arm |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 0 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 0 |
| White | 3 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Region of Enrollment(Participants) | Glyburide Treatment Arm |
|---|---|
| United States | 3 |
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Plan to share: Undecided
Ran from Feb 2017 to primary completion in Feb 2021, 47 months.
Results were first posted in Jun 2022, 1 year 3 months after primary completion.
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This study is terminated, as verified in Jun 2022. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Glyburide