Trial · NCT02524379
Spinal Cord Injury Neuroprotection With Glyburide
NCT02524379, Phase 1, Phase 2, Terminated, Ohio State University; results first posted 2022-06-07
3 sourcestrials-2026-11-12-0.5.0
Cite this record
ConductScience Library. Spinal Cord Injury Neuroprotection With Glyburide. Trials, record NCT02524379. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT02524379
On this page
Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- Spinal Cord Injury Neuroprotection With Glyburide
- NCT number
- NCT02524379
- Status
- Terminated
- Phases
- Phase 1, Phase 2
- Enrollment
- 3 participants, actual
- Lead sponsor
- Ohio State University
- Conditions
- Acute Spinal Cord Injury
- Interventions
- Glyburide
- First posted
- 2015-08-14
- Last updated
- 2022-07-05
- Results first posted
- 2022-06-07
Source ClinicalTrials.gov
Registered outcomes4
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Number of Participants With tSCI Recruited Within the Specified Time Window | Enrollment Period (within 8 hours of tSCI) | 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. |
| Primary | Number of Drug Related Adverse Events | One year post enrollment | A measure of safety of treating patients with traumatic spinal cord injury with Glyburide administered orally within a short injury-to-drug time window. |
| Secondary | Number of Participants With Neurologic Recovery Following tSCI | One year post enrollment | 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. |
| Secondary | Serum Pharmacokinetic and Biomarker Analysis | Enrollment through post-treatment day 7 | 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 |
Source ClinicalTrials.gov
Outcomes4
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Number of Participants With tSCI Recruited Within the Specified Time Window | Enrollment Period (within 8 hours of tSCI) | A total of 24 patients with acute cervical tSCI were screened over the course of the study for eligibility. | Participants | COUNT_OF_PARTICIPANTS |
| PRIMARY | Number of Drug Related Adverse Events | One year post enrollment | Events | NUMBER | |
| SECONDARY | Number of Participants With Neurologic Recovery Following tSCI | One year post enrollment | Participants | COUNT_OF_PARTICIPANTS | |
| SECONDARY | Serum Pharmacokinetic and Biomarker Analysis | Enrollment through post-treatment day 7 | Principal Investigator left university: Samples were not analyzed at study termination. |
Source ClinicalTrials.gov
Results by group3
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Number of Participants With tSCI Recruited Within the Specified Time Window | Glyburide Treatment Arm | 3 | Participants | ||
| Number of Drug Related Adverse Events | Glyburide Treatment Arm | 0 | Events | ||
| Number of Participants With Neurologic Recovery Following tSCI | Glyburide Treatment Arm | 2 | Participants |
Source ClinicalTrials.gov
Participant flow3
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | Glyburide Treatment Arm | 3 | |
| Overall Study | COMPLETED | Glyburide Treatment Arm | 2 | |
| Overall Study | NOT COMPLETED | Glyburide Treatment Arm | 1 |
Source ClinicalTrials.gov
Adverse events8
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Thromocytopenia | Blood and lymphatic system disorders | Glyburide Treatment Arm | 1 | 3 | 1 |
| other | Anemia | Blood and lymphatic system disorders | Glyburide Treatment Arm | 1 | 3 | 1 |
| other | Urinary Tract Infection (UTI) | Infections and infestations | Glyburide Treatment Arm | 1 | 3 | 1 |
| other | Hypoglycemia | Metabolism and nutrition disorders | Glyburide Treatment Arm | 1 | 3 | 1 |
| serious | Bradycardia | Cardiac disorders | Glyburide Treatment Arm | 1 | 3 | 1 |
| serious | Other Dysrhythmia (Tachy-brady syndrome) | Cardiac disorders | Glyburide Treatment Arm | 1 | 3 | 1 |
| serious | Acute Renal Failure | Gastrointestinal disorders | Glyburide Treatment Arm | 1 | 3 | 1 |
| serious | Acute respiratory distress syndrome (ARDS) - Atelecetasis | Respiratory, thoracic and mediastinal disorders | Glyburide Treatment Arm | 1 | 3 | 1 |
Source ClinicalTrials.gov
Adverse event totals3
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Glyburide Treatment Arm | 1 | 3 |
| Total, other adverse events | Glyburide Treatment Arm | 1 | 3 |
| Total, serious adverse events | Glyburide Treatment Arm | 2 | 3 |
Source ClinicalTrials.gov
Papers1
The papers the trial lists on ClinicalTrials.gov.
| PMID | Listed as |
|---|---|
| 31601596 | DERIVED |
Source PubMed
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT02524379
GET https://conductscience.org/api/trials/v1/NCT02524379/registered