Columbus, Ohio 43210


Purpose:

The purpose of this study is to determine the safety of using oral Glyburide in patients with acute traumatic cervical spinal cord injuries (SCI).


Study summary:

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.


Criteria:

Inclusion Criteria: 1. Age: ≥ 18 years and ≤ 80 years 2. Written informed consent by patient or legal authorized representative 3. No other life-threatening injury 4. No evidence of sepsis 5. Acute cervical SCI with ASIA Impairment Scale grade A, B or C on admission 6. Non-penetrating SCI at neurologic level from C2 to C8 7. Initiation of study drug within 8 hours of injury Exclusion Criteria 1. Unconsciousness or other mental impairment that prevents neurological assessment within the first 8 hours 2. Acute SCI with ASIA Impairment Scale grade D or E 3. Currently involved in another non-observational SCI research study or receiving another investigational drug 4. History of hypersensitivity to sulfonylureas, in particular glyburide, or any of its components 5. Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation (at discretion of the site investigator) 6. Unable to commit to the follow-up schedule 7. A recent history of regular substance abuse (illicit drugs, alcohol), which in the opinion of the investigator would interfere with the subject's participation in the study 8. Any condition likely to result in the patient's death within the next 12 months 9. Prisoner 10. Severe renal disorder from the patient's history (e.g. dialysis) or baseline eGFR of < 30 mL/min/1.73 m2 11. Known severe liver disease, or ALT > 3 times upper limit of normal or bilirubin > 2 times upper limit normal. Subjects may be randomized if liver function tests have been drawn but are not yet available and the subject has no known history of liver disease; however, treatment with DiaBeta will be discontinued prior to the second dose if liver function tests indicate ALT > 3 times upper limit of normal or bilirubin > 2 times upper limit of normal 12. Blood glucose <55 mg/dL at enrollment or immediately prior to administration of DiaBeta, or a clinically significant history of hypoglycemia 13. 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 14. Known treatment with Bosentan within past 7 days 15. Known G6PD enzyme deficiency 16. Pregnancy: Women must be either post-menopausal, permanently sterilized or, if ≤ 50 years old, must have a negative test for pregnancy obtained before enrollment 17. Breast-feeding women who do not agree to stop breast-feeding during and for 7 days following the end of oral glyburide administration 18. Subjects who in the opinion of the investigator are not suitable for inclusion in the study (reason to be documented).


Study is Available At:


Original ID:

2014H0335


NCT ID:

NCT02524379


Secondary ID:


Study Acronym:

SCING


Brief Title:

Spinal Cord Injury Neuroprotection With Glyburide


Official Title:

Spinal Cord Injury Neuroprotection With Glyburide; 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


Overall Status:

Recruiting


Study Phase:

Phase 1/Phase 2


Genders:

N/A


Minimum Age:

18 Years


Maximum Age:

80 Years


Quick Facts

Healthy Volunteers
Oversight Has DMC
Study Is FDA Regulated
Study Is Section 801
Has Expanded Access

Study Source:

Ohio State University


Oversight Authority:

  • United States: Food and Drug Administration
  • United States: Institutional Review Board


Reasons Why Stopped:


Study Type:

Interventional


Study Design:


Number of Arms:

1


Number of Groups:

0


Total Enrollment:

10


Enrollment Type:

Anticipated


Overall Contact Information

Official Name:H. Francis Farhadi, MD, PhD
Principal Investigator
Ohio State University
Primary Contact:Amy J Minnema
(614) 685-9827
amy.minnema@osumc.edu

Study Dates

Start Date:February 14, 2017
Completion Date:March 2022
Completion Type:Anticipated
Primary Completion Date:March 2022
Primary Completion Type:Anticipated
Verification Date:July 2019
Last Changed Date:July 2, 2019
First Received Date:August 13, 2015

Study Outcomes

Outcome Type:Primary Outcome
Measure:Rate of recruitment of patients with tSCI within the specified time window
Time Frame:Enrollment Period (within 8 hours of tSCI)
Safety Issues:False
Description: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 Type:Primary Outcome
Measure:Number of drug related adverse events
Time Frame:One year post enrollment
Safety Issues:False
Description: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 Type:Secondary Outcome
Measure:Neurologic recovery following tSCI
Time Frame:One year post enrollment
Safety Issues:False
Description: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 Type:Secondary Outcome
Measure:Serum pharmacokinetic and biomarker analysis
Time Frame:Enrollment through post-treatment day 7
Safety Issues:False
Description: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-lin
Outcome Type:Secondary Outcome
Measure:Spinal cord lesion imaging analysis
Time Frame:Enrollment through post-treatment day 2
Safety Issues:False
Description:Finally, spinal cord lesion volume will be analyzed using standard sequences (including T1 and T2-weighted images) to assess the extent of the hemorrhagic lesion and surrounding edema. Patients will be imaged on the day of admission and on day 2 following

Study Interventions

Intervention Type:Drug
Name:Glyburide
Description:3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.
Arm Name:Glyburide Treatment Arm

Study Arms

Study Arm Type:Experimental
Arm Name:Glyburide Treatment Arm
Description: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.

Study Agencies

Agency Class:Other
Agency Type:Lead Sponsor
Agency Name:Ohio State University

Sample and Retention Information

There are no available Sample and Retention Information

Study References

There are no available Study References

Data Source: ClinicalTrials.gov

Date Processed: January 21, 2020

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