Stopped: Principal investigator has left the university; there were not enough participants to analyze the data.
United States3 participantsStarted 2017-02-14
Plain-language 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).
Who can participate
Age range18 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age: ≥ 18 years and ≤ 80 years
✓. Written informed consent by patient or legal authorized representative
✓. No other life-threatening injury
✓. No evidence of sepsis
✓. Acute cervical SCI with ASIA Impairment Scale grade A, B or C on admission
✓. Non-penetrating SCI at neurologic level from C2 to C8
✓. Initiation of study drug within 8 hours of injury
Exclusion criteria
✕. Unconsciousness or other mental impairment that prevents neurological assessment within the first 8 hours
✕. Acute SCI with ASIA Impairment Scale grade D or E
✕. Currently involved in another non-observational SCI research study or receiving another investigational drug
✕. History of hypersensitivity to sulfonylureas, in particular glyburide, or any of its components
✕. Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation (at discretion of the site investigator)
✕. Unable to commit to the follow-up schedule
✕
What they're measuring
1
Number of Participants With tSCI Recruited Within the Specified Time Window
Timeframe: Enrollment Period (within 8 hours of tSCI)
. 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
✕. Any condition likely to result in the patient's death within the next 12 months