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Spinal Cord Injury Neuroprotection With Glyburide (SCING)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05426681
Recruitment Status : Recruiting
First Posted : June 22, 2022
Last Update Posted : October 21, 2022
Information provided by (Responsible Party):
H. Francis Farhadi, University of Kentucky

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Spinal Cord Injury Drug: GlyBURIDE Oral Tablet Phase 1

Detailed 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 12 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : July 7, 2022
Estimated Primary Completion Date : May 2027
Estimated Study Completion Date : May 2028

Resource links provided by the National Library of Medicine

Drug Information available for: Glyburide

Arm Intervention/treatment
Experimental: Glyburide treatment arm Drug: GlyBURIDE Oral Tablet

Enrolled patients will receive 12 doses of Glyburide starting within 8 hours of spinal cord injury. The dosing regimen involves an initial dose of 1.25mg followed by 11 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.

Intervention: Drug: Glyburide

Other Name: Diabeta

Primary Outcome Measures :
  1. Rate of recruitment of patients with tSCI within the specified time window. [ Time Frame: within 8 hours of tSCI ]
    A measure of feasibility of undertaking a large phase II study among this population of patients where treatment must begin within a short injury-to-drug time window.

  2. Number of drug related adverse events. [ Time Frame: One year post treatment ]
    A measure of safety of treating patients with traumatic spinal cord injury with Glyburide administered orally.

Secondary Outcome Measures :
  1. Neurologic recovery following tSCI [ Time Frame: One year post enrollment. ]

    Neurologic status be assessed using the American Spinal Injury Association Impairment Scale. This neurological exam assesses sensory and motor impairments using touch and pin prick evaluations in each dermatome and muscle strength. Right and left body sides are evaluated independently. Lower the scores indicate greater degree of impairment.

    Touch and pin prick perception is scored using a 0-2 and NT grade. Where 0= Absent, 1= hypo/hypersensitivity, 2= normal sensation, and NT= not testable. Scores for each body side are added together and summed for a total sensation score. Maximum score possible for this section is 112 per side.

    Muscle function is rated on a 0-5 scale. Where 0= total paralysis, 1= palpable/visible contraction, 2= active movement, full ROM with gravity eliminated, 3= active movement, full ROM against gravity, 4= active movement, full ROM with moderate resistance, 5= Normal movement and strength, and NT= not tested. Maximum score for this section is 50 per side.

  2. Serum Pharmacokinetics to measure Glyburide concentrations. [ Time Frame: Enrollment through post-treatment day 7. ]
    Plasma concentrations of Glyburide will be serially quantified through day 3 following tSCI to evaluate the pharmacokinetics of the investigational drug. Comparisons will be made to reported levels achieved in healthy patient cohorts.

  3. Biomarker Analysis [ Time Frame: Enrollment, Day 3, and Day 7 ]
    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

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes

Inclusion Criteria:

  • No life threatening injuries resulting from the traumatic accident
  • No evidence of sepsis
  • Acute cervical or thoracic SCI with ASIA Impairment Scale Grade A, B, or C od admission.
  • Non-penetrating SCI at neurologic level from C2 to C8 or T1 to T12

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
  • Any condition likely to result in the patient's death within the next 12 months
  • Severe renal disorder from the patient's history (e.g. dialysis) or baseline eGFR of < 30 mL/min/1.73 m2
  • Known severe liver disease, or ALT > 3 times upper limit of normal or bilirubin
  • Blood glucose <55 mg/dL at enrollment or immediately prior to administration of DiaBeta, or a clinically significant history of hypoglycemia
  • 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
  • Known G6PD enzyme deficiency

Information from the National Library of Medicine

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 identifier (NCT number): NCT05426681

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Contact: H. Francis Farhadi, MD, PhD 859-323-5661
Contact: Jaimie L Hixson, BS 8593231908

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United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40536
Contact: Francis Farhadi, MD, PhD    859-562-0247   
Contact: Jaimie Hixson, BS    859-323-4585   
Sponsors and Collaborators
University of Kentucky
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Responsible Party: H. Francis Farhadi, Associate Professor of Neurosurgery, University of Kentucky Identifier: NCT05426681    
Other Study ID Numbers: 77662
First Posted: June 22, 2022    Key Record Dates
Last Update Posted: October 21, 2022
Last Verified: October 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Spinal Cord Injuries
Wounds and Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Hypoglycemic Agents
Physiological Effects of Drugs