Trial Outcomes & Findings for Spinal Cord Injury Neuroprotection With Glyburide (NCT NCT02524379)

Last Updated: 2022-07-05

Results Overview

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.

Recruitment status

TERMINATED

Study phase

PHASE1/PHASE2

Target enrollment

3 participants

Primary outcome timeframe

Enrollment Period (within 8 hours of tSCI)

Results posted on

2022-07-05

Participant Flow

Participant milestones

Participant milestones
Measure	Glyburide Treatment Arm 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. Glyburide: 3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.
Overall Study STARTED	3
Overall Study COMPLETED	2
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Reasons for withdrawal
Measure	Glyburide Treatment Arm 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. Glyburide: 3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.
Overall Study Death	1

Baseline Characteristics

Spinal Cord Injury Neuroprotection With Glyburide

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Glyburide Treatment Arm n=3 Participants 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. Glyburide: 3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	2 Participants n=5 Participants
Age, Categorical >=65 years	1 Participants n=5 Participants
Age, Continuous	57 years STANDARD_DEVIATION 10.03 • n=5 Participants
Sex: Female, Male Female	1 Participants n=5 Participants
Sex: Female, Male Male	2 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	3 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants
Race (NIH/OMB) White	3 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	3 Participants n=5 Participants

PRIMARY outcome

Timeframe: Enrollment Period (within 8 hours of tSCI)

Population: A total of 24 patients with acute cervical tSCI were screened over the course of the study for eligibility.

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.

Outcome measures

Outcome measures
Measure	Glyburide Treatment Arm n=24 Participants 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. 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	3 Participants

PRIMARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Glyburide Treatment Arm n=3 Participants 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. Glyburide: 3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.
Number of Drug Related Adverse Events	0 Events

SECONDARY outcome

Timeframe: 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.

Outcome measures

Outcome measures
Measure	Glyburide Treatment Arm n=2 Participants 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. Glyburide: 3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.
Number of Participants With Neurologic Recovery Following tSCI	2 Participants

SECONDARY outcome

Timeframe: Enrollment through post-treatment day 7

Population: Principal Investigator left university: Samples were not analyzed at study termination.

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

Outcome measures

Outcome data not reported

Adverse Events

Glyburide Treatment Arm

Serious events: 2 serious events

Other events: 1 other events

Deaths: 1 deaths

Serious adverse events

Serious adverse events
Measure	Glyburide Treatment Arm n=3 participants at risk 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. Glyburide: 3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.
Cardiac disorders Bradycardia	33.3% 1/3 • Number of events 1 • 1 year
Cardiac disorders Other Dysrhythmia (Tachy-brady syndrome)	33.3% 1/3 • Number of events 1 • 1 year
Gastrointestinal disorders Acute Renal Failure	33.3% 1/3 • Number of events 1 • 1 year
Respiratory, thoracic and mediastinal disorders Acute respiratory distress syndrome (ARDS) - Atelecetasis	33.3% 1/3 • Number of events 1 • 1 year

Other adverse events

Other adverse events
Measure	Glyburide Treatment Arm n=3 participants at risk 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. Glyburide: 3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.
Blood and lymphatic system disorders Thromocytopenia	33.3% 1/3 • Number of events 1 • 1 year
Blood and lymphatic system disorders Anemia	33.3% 1/3 • Number of events 1 • 1 year
Infections and infestations Urinary Tract Infection (UTI)	33.3% 1/3 • Number of events 1 • 1 year
Metabolism and nutrition disorders Hypoglycemia	33.3% 1/3 • Number of events 1 • 1 year

Additional Information

Shelby Miracle

The Ohio State University

Phone: 614-366-1648

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place