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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.
 
ClinicalTrials.gov Identifier: NCT02524379
Recruitment Status : Recruiting
First Posted : August 14, 2015
Last Update Posted : July 5, 2019
Sponsor:
Information provided by (Responsible Party):
H Francis Farhadi, MD, PhD, Ohio State University

Tracking Information
First Submitted Date  ICMJE August 13, 2015
First Posted Date  ICMJE August 14, 2015
Last Update Posted Date July 5, 2019
Actual Study Start Date  ICMJE February 14, 2017
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • 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.
Original Primary Outcome Measures  ICMJE
 (submitted: August 13, 2015)
The number of patients experiencing adverse events after administration of RP-1127 [ Time Frame: One year post treatment ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 2, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Spinal Cord Injury Neuroprotection With Glyburide
Official Title  ICMJE 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
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).
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Acute Spinal Cord Injury
Intervention  ICMJE Drug: Glyburide
3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.
Study Arms  ICMJE 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.
Intervention: Drug: Glyburide
Publications * Minnema AJ, Mehta A, Boling WW, Schwab J, Simard JM, Farhadi HF. SCING-Spinal Cord Injury Neuroprotection with Glyburide: a pilot, open-label, multicentre, prospective evaluation of oral glyburide in patients with acute traumatic spinal cord injury in the USA. BMJ Open. 2019 Oct 10;9(10):e031329. doi: 10.1136/bmjopen-2019-031329.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: August 13, 2015)
10
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 2022
Estimated Primary Completion Date March 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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).
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Amy J Minnema (614) 685-9827 amy.minnema@osumc.edu
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02524379
Other Study ID Numbers  ICMJE 2014H0335
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
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
IPD Sharing Statement  ICMJE
Plan to Share IPD: Undecided
Responsible Party H Francis Farhadi, MD, PhD, Ohio State University
Study Sponsor  ICMJE Ohio State University
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: H. Francis Farhadi, MD, PhD Ohio State University
PRS Account Ohio State University
Verification Date July 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP