Spinal Cord Injury Neuroprotection With Glyburide

NCT02524379 | Terminated Phase 1 Results DMC FDA Drug

• 1 other identifier: 2014H0335
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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).

Conditions

Acute Spinal Cord Injury

Outcome Measures

Primary Outcomes (2)

• Number of Participants With tSCI Recruited Within the Specified Time Window

  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.

  Enrollment Period (within 8 hours of tSCI)

• Number of Drug Related Adverse Events

  A measure of safety of treating patients with traumatic spinal cord injury with Glyburide administered orally within a short injury-to-drug time window.

  One year post enrollment

Secondary Outcomes (2)

• Number of Participants With Neurologic Recovery Following tSCI

  One year post enrollment

• Serum Pharmacokinetic and Biomarker Analysis

  Enrollment through post-treatment day 7

Study Arms (1)

Glyburide Treatment Arm

EXPERIMENTAL

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

Interventions

Glyburide DRUG

3 day drug regimen beginning 8 hours after acute traumatic spinal cord injury.

Glyburide Treatment Arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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
• Other illness (including mental disorder) that could preclude accurate medical and neurological evaluation (at discretion of the site investigator)
• Unable to commit to the follow-up schedule
• 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
• Any condition likely to result in the patient's death within the next 12 months
• Prisoner
• 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 \> 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
• 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 treatment with Bosentan within past 7 days
• Known G6PD enzyme deficiency

Sponsors & Collaborators

• Ohio State University: lead

Study Sites (1)

The Ohio State University

Columbus, Ohio, 43210, United States

Location

Related Publications (1)

• 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.

  PMID: 31601596 DERIVED

MeSH Terms

Interventions

Glyburide

Intervention Hierarchy (Ancestors)

Sulfonylurea Compounds; Urea; Amides; Organic Chemicals; Sulfones; Sulfur Compounds

Results Point of Contact

• Title: Shelby Miracle
• Organization: The Ohio State University

shelby.miracle@osumc.edu

614-366-1648

Study Officials

• H. Francis Farhadi, MD, PhD

  Ohio State University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 13, 2015
• First Posted: August 14, 2015
• Study Start: February 14, 2017
• Primary Completion: February 8, 2021
• Study Completion: February 8, 2021
• Last Updated: July 5, 2022
• Results First Posted: June 7, 2022

Record last verified: 2022-06

Locations

US (1)