Spinal Cord Injury Neuroprotection With Glyburide

• Status: Terminated
• Trial end date: 2021-02-08
• Target enrollment: 0
• Participant gender: All

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).

• Phase: Phase 1/Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Ohio State University
• Treatments: Glyburide

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).