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Spinal Cord Injury Neuroprotection With Glyburide (SCING)

Primary Purpose

Acute Spinal Cord Injury

Status
Recruiting
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
GlyBURIDE Oral Tablet
Sponsored by
University of Kentucky
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Acute Spinal Cord Injury

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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
  • 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

Sites / Locations

  • University of KentuckyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Glyburide treatment arm

Arm Description

Outcomes

Primary Outcome Measures

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.
Number of drug related adverse events.
A measure of safety of treating patients with traumatic spinal cord injury with Glyburide administered orally.

Secondary Outcome Measures

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.
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.
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

Full Information

First Posted
June 13, 2022
Last Updated
October 3, 2023
Sponsor
University of Kentucky
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1. Study Identification

Unique Protocol Identification Number
NCT05426681
Brief Title
Spinal Cord Injury Neuroprotection With Glyburide
Acronym
SCING
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
July 7, 2022 (Actual)
Primary Completion Date
May 2027 (Anticipated)
Study Completion Date
May 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Kentucky

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Acute Spinal Cord Injury

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
12 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Glyburide treatment arm
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
GlyBURIDE Oral Tablet
Other Intervention Name(s)
Diabeta
Intervention Description
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
Primary Outcome Measure Information:
Title
Rate of recruitment of patients with tSCI within the specified time window.
Description
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.
Time Frame
within 8 hours of tSCI
Title
Number of drug related adverse events.
Description
A measure of safety of treating patients with traumatic spinal cord injury with Glyburide administered orally.
Time Frame
One year post treatment
Secondary Outcome Measure Information:
Title
Neurologic recovery following tSCI
Description
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.
Time Frame
One year post enrollment.
Title
Serum Pharmacokinetics to measure Glyburide concentrations.
Description
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.
Time Frame
Enrollment through post-treatment day 7.
Title
Biomarker Analysis
Description
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, Day 3, and Day 7

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
H. Francis Farhadi, MD, PhD
Phone
859-323-5661
Email
francis.farhadi@uky.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Jaimie L Hixson, BS
Phone
8593231908
Email
jlhend3@uky.edu
Facility Information:
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40536
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Francis Farhadi, MD, PhD
Phone
859-562-0247
Email
francis.farhadi@uky.edu
First Name & Middle Initial & Last Name & Degree
Jaimie Hixson, BS
Phone
859-323-4585
Email
jlhend3@uky.edu

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Spinal Cord Injury Neuroprotection With Glyburide

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