Spinal Cord Injury Neuroprotection With Glyburide — SCING  

Acute Spinal Cord Injury Clinical Trial

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

Status Recruiting

Clinical Trial 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Acute Spinal Cord Injury
• Spinal Cord Injuries
• Wounds and Injuries

• NCT number: NCT05426681
• Study type: Interventional
• Source: University of Kentucky
• Contact: H. Francis Farhadi, MD, PhD
• Phone: 859-323-5661
• Email: francis.farhadi@uky.edu
• Status: Recruiting
• Phase: Phase 1
• Start date: July 7, 2022
• Completion date: May 2028