ClinicalTrials.gov
ClinicalTrials.gov Menu

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 : February 12, 2018
Sponsor:
Information provided by (Responsible Party):
H Francis Farhadi, Ohio State University

Brief Summary:
The purpose of this study is to determine the safety of using oral Glyburide (DiaBeta) in patients with acute traumatic cervical spinal cord injuries (SCI).

Condition or disease Intervention/treatment Phase
Acute Spinal Cord Injury Drug: Diabeta Oral Product 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 (DiaBeta), 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. Every one who takes part in this study will have labs drawn and adverse events assessed through Day 14 or discharge (whichever is earlier), and be carefully monitored throughout their hospitalization. Study participation will last for 365 days (+/- 30 days), with post-hospitalization follow up occuring on Days 28, 42, 84, 182 and 365.

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 : February 2019
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Glyburide

Arm Intervention/treatment
Experimental: DiaBeta Treatment Arm
Enrolled patients will receive 12 doses of DiaBeta 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 DiaBeta on Day 1, Day 2 and Day 3 will be 3.125 mg, 2.5 mg, and 2.5 mg respectively.
Drug: Diabeta Oral Product
3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.
Other Name: Glyburide




Primary Outcome Measures :
  1. The number of patients experiencing adverse events after administration of DiaBeta [ Time Frame: One year post treatment ]


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.


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

Locations
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
Principal Investigator: H. Francis Farhadi, MD, PhD Ohio State University

Responsible Party: H Francis Farhadi, 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: February 12, 2018
Last Verified: February 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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:
Wounds and Injuries
Spinal Cord Injuries
Spinal Cord Diseases
Central Nervous System Diseases
Nervous System Diseases
Trauma, Nervous System
Glyburide
Hypoglycemic Agents
Physiological Effects of Drugs