Spinal Cord Injury Neuroprotection With Glyburide (SCING)
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|ClinicalTrials.gov Identifier: NCT02524379|
Recruitment Status : Recruiting
First Posted : August 14, 2015
Last Update Posted : July 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Acute Spinal Cord Injury||Drug: Glyburide||Phase 1 Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||10 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Spinal Cord Injury Neuroprotection With Glyburide; 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|
|Actual Study Start Date :||February 14, 2017|
|Estimated Primary Completion Date :||March 2022|
|Estimated Study Completion Date :||March 2022|
Experimental: Glyburide Treatment Arm
Enrolled patients will receive 12 doses of Glyburide starting within 8 hours of SCI. The dosing regimen involves an initial dose of 1.25 mg followed by eleven consecutive doses of 0.625 mg every 6 hours. The total daily dose of Glyburide on Day 1, Day 2 and Day 3 will be 3.125 mg, 2.5 mg, and 2.5 mg respectively.
3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.
- Rate of recruitment of patients with tSCI within the specified time window [ Time Frame: Enrollment Period (within 8 hours of tSCI) ]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.
- Number of drug related adverse events [ Time Frame: One year post enrollment ]A measure of safety of treating patients with traumatic spinal cord injury with Glyburide administered orally within a short injury-to-drug time window.
- Neurologic recovery following tSCI [ Time Frame: One year post enrollment ]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.
- Serum pharmacokinetic and biomarker analysis [ Time Frame: Enrollment through post-treatment day 7 ]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
- Spinal cord lesion imaging analysis [ Time Frame: Enrollment through post-treatment day 2 ]Finally, spinal cord lesion volume will be analyzed using standard sequences (including T1 and T2-weighted images) to assess the extent of the hemorrhagic lesion and surrounding edema. Patients will be imaged on the day of admission and on day 2 following injury demarcating a defined time window for assessment of post-tSCI lesion expansion 18. Volumetric assessments of lesion size (based on manual outlines) will be performed and compared at the two time-points by the study neuroradiologist to assess for the progression of intrinsic cord signal changes.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02524379
|Contact: Amy J Minnema||(614) firstname.lastname@example.org|
|United States, Ohio|
|The Ohio State University||Recruiting|
|Columbus, Ohio, United States, 43210|
|Contact: Amy J Minnema 614-685-9827 email@example.com|
|Principal Investigator: Francis Farhadi, MD, PhD|
|Principal Investigator:||H. Francis Farhadi, MD, PhD||Ohio State University|