Columbus, Ohio 43210


Purpose:

The purpose of this study is to determine the safety of using intravenous Glyburide (RP-1127) in patients with acute traumatic cervical spinal cord injuries (SCI).


Study summary:

This study will include patients between 18 and 70 years who have experienced acute traumatic cervical spinal cord injury (specifically ASIA A, B or C). Patients will then begin an infusion of RP-1127 (Glyburide), which must be started within 6 hours of injury and continued for 72 hours at a daily dose of 2.99 mg on Day 1, 2.67 mg on Day 2 and 2.67 mg on Day 3. If indicated, the patient will also have surgical intervention for spinal cord decompression and spinal stabilization. Every one who takes part in this study will have labs drawn and adverse events assessed through Day 14 or discharge (whichever is earlier), and be carefully monitored throughout their hospitalization. Study participation will last for 365 days (+/- 30 days), with post-hospitalization follow up occuring on Days 28, 42, 84, 182 and 365.


Criteria:

Inclusion Criteria: 1. Age: ≥ 18 years and ≤ 70 years 2. Written informed consent by patient 3. No other life-threatening injury 4. No evidence of sepsis 5. Acute cervical SCI with ASIA Impairment Scale grade A, B or C 6. Non-penetrating SCI at neurologic level from C4 to C8 7. No cognitive impairment that would preclude an informed consent, including moderate or severe traumatic brain injury (GCS < 13) 8. Initiation of RP-1127 within 6 hours of injury 9. Women of childbearing potential must have a negative serum pregnancy test Exclusion Criteria: 1. Unable to receive RP-1127 intravenously 2. Inability to undergo MRI (pacemaker or other metallic implant) 3. Concomitant traumatic head injury with GCS < 13 4. Acute cervical SCI with ASIA Impairment Scale grade D or E 5. Associated unilateral or bilateral cervical facet dislocation (as seen on CT) 6. Currently involved in another non-observational SCI research study or receiving another investigational drug 7. History of Hypersensitivity to sulfonylureas, RP-1127 or any of its components 8. Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation (at discretion of the site investigator) 9. Unable to commit to the follow-up schedule 10. A recent history of regular substance abuse (illicit drugs, alcohol) 11. Any condition likely to result in the patient's death within the next 12 months 12. Prisoner 13. Severe renal disorder from the patient's history (e.g. dialysis) or eGFR of < 30 mL/min/1.73 m2 14. 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 RP-1127 will be discontinued at ≤ 3 hours if liver function tests indicate ALT >3 times upper limit of normal or bilirubin > 2 times upper limit of normal 15. Blood glucose <55 mg/dL at enrollment or immediately prior to administration of RP-1127, or a clinically significant history of hypoglycemia 16. 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 17. Known treatment with Bosentan within past 7 days 18. Known G6PD enzyme deficiency 19. Pregnancy: Women must be either post-menopausal, permanently sterilized or, if ≤ 50 years old, must have a negative test for pregnancy obtained before enrollment 20. Breast-feeding women who do not agree to stop breast-feeding during RP-1127 infusion and for 7 days following the end of RP-1127 infusion


NCT ID:

NCT02524379


Primary Contact:

Principal Investigator
Hooman F Farhadi, MD, PhD
Ohio State University

Amy J Minnema
Phone: (614) 685-9827
Email: amy.minnema@osumc.edu


Backup Contact:

N/A


Location Contact:

Columbus, Ohio 43210
United States

Desy Vounousakis, MS
Phone: 614-688-6412
Email: desy.vounousakis@osumc.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: November 21, 2017

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