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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 4, 2019
Sponsor:
Information provided by (Responsible Party):
H Francis Farhadi, MD, PhD, Ohio State University

Brief 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).

Condition or disease Intervention/treatment Phase
Acute Spinal Cord Injury Drug: Glyburide Phase 1 Phase 2

Detailed Description:
This study will include patients between 18 and 80 years who have experienced acute traumatic cervical spinal cord injury (specifically ASIA A, B or C). Patients will then begin an oral drug regimen of Glyburide, which must be started within 8 hours of injury and continued for 72 hours at a daily dose of 3.125 mg on Day 1, 2.5 mg on Day 2 and 2.5 mg on Day 3. If indicated, the patient will also have surgical intervention for spinal cord decompression and spinal stabilization. Each patient who takes part in this study will have labs drawn regularly and adverse events assessed daily through Day 14 or 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 : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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

Resource links provided by the National Library of Medicine

Drug Information available for: Glyburide

Arm Intervention/treatment
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.
Drug: Glyburide
3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.




Primary Outcome Measures :
  1. 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.

  2. 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.


Secondary Outcome Measures :
  1. 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.

  2. 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

  3. 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.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Age: ≥ 18 years and ≤ 80 years
  2. Written informed consent by patient or legal authorized representative
  3. No other life-threatening injury
  4. No evidence of sepsis
  5. Acute cervical SCI with ASIA Impairment Scale grade A, B or C on admission
  6. Non-penetrating SCI at neurologic level from C2 to C8
  7. Initiation of study drug within 8 hours of injury

Exclusion Criteria

  1. Unconsciousness or other mental impairment that prevents neurological assessment within the first 8 hours
  2. Acute SCI with ASIA Impairment Scale grade D or E
  3. Currently involved in another non-observational SCI research study or receiving another investigational drug
  4. History of hypersensitivity to sulfonylureas, in particular glyburide, or any of its components
  5. Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation (at discretion of the site investigator)
  6. Unable to commit to the follow-up schedule
  7. 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
  8. Any condition likely to result in the patient's death within the next 12 months
  9. Prisoner
  10. Severe renal disorder from the patient's history (e.g. dialysis) or baseline eGFR of < 30 mL/min/1.73 m2
  11. 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 DiaBeta will be discontinued prior to the second dose if liver function tests indicate ALT > 3 times upper limit of normal or bilirubin > 2 times upper limit of normal
  12. Blood glucose <55 mg/dL at enrollment or immediately prior to administration of DiaBeta, or a clinically significant history of hypoglycemia
  13. 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
  14. Known treatment with Bosentan within past 7 days
  15. Known G6PD enzyme deficiency
  16. Pregnancy: Women must be either post-menopausal, permanently sterilized or, if ≤ 50 years old, must have a negative test for pregnancy obtained before enrollment
  17. Breast-feeding women who do not agree to stop breast-feeding during and for 7 days following the end of oral glyburide administration
  18. Subjects who in the opinion of the investigator are not suitable for inclusion in the study (reason to be documented).

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 ClinicalTrials.gov identifier (NCT number): NCT02524379


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

Locations
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United States, Ohio
The Ohio State University Recruiting
Columbus, Ohio, United States, 43210
Contact: Amy J Minnema    614-685-9827    amy.minnema@osumc.edu   
Principal Investigator: Francis Farhadi, MD, PhD         
Sponsors and Collaborators
Ohio State University
Investigators
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Principal Investigator: H. Francis Farhadi, MD, PhD Ohio State University

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Responsible Party: H Francis Farhadi, MD, PhD, Assistant Professor, Ohio State University
ClinicalTrials.gov Identifier: NCT02524379     History of Changes
Other Study ID Numbers: 2014H0335
First Posted: August 14, 2015    Key Record Dates
Last Update Posted: July 4, 2019
Last Verified: July 2019
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
Product Manufactured in and Exported from the U.S.: 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
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs