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Clinical Trial Details — Status: Terminated

Administrative data

NCT number NCT02524379
Other study ID # 2014H0335
Secondary ID
Status Terminated
Phase Phase 1/Phase 2
First received
Last updated
Start date February 14, 2017
Est. completion date February 8, 2021

Study information

Verified date June 2022
Source Ohio State University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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


Description:

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.


Recruitment information / eligibility

Status Terminated
Enrollment 3
Est. completion date February 8, 2021
Est. primary completion date February 8, 2021
Accepts healthy volunteers No
Gender All
Age group 18 Years to 80 Years
Eligibility 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 Design


Intervention

Drug:
Glyburide
3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.

Locations

Country Name City State
United States The Ohio State University Columbus Ohio

Sponsors (1)

Lead Sponsor Collaborator
Ohio State University

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. Enrollment Period (within 8 hours of tSCI)
Primary 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. One year post enrollment
Secondary 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. One year post enrollment
Secondary 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 Enrollment through post-treatment day 7
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