Status:
COMPLETED
Glyburide (RP-1127) for Traumatic Brain Injury (TBI)
Lead Sponsor:
Remedy Pharmaceuticals, Inc.
Collaborating Sponsors:
U.S. Army Medical Research and Development Command
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Conditions:
Traumatic Brain Injury
Eligibility:
All Genders
18-75 years
Phase:
PHASE2
Brief Summary
The primary objectives of this study are to assess whether participants with traumatic brain injury (TBI) administered glyburide begun within 10 hours of injury will show a decrease in magnetic resona...
Eligibility Criteria
Inclusion
- Documented closed head TBI
- Clearly defined time of injury no more than 10 hours before administration of study drug/placebo
- GCS 4-14. The GCS will be obtained free of the effects of sedating and/or paralytic drug. Complicated mild must have GCS 13-14 and one or more of the following: Intraparenchymal clots or contusions in aggregate \> 10cc; Midline shift \> 5mm; IVH, SDH, EDH seen on more than one CT scan slice.
- Age 18-75 years
- Patients in whom a dedicated peripheral IV line can be placed for study drug administration
- Written consent obtained from legally authorized representative (LAR)
Exclusion
- No documented TBI or time of impact not certain
- Penetrating brain injury
- Spinal column instability and/or spinal cord injury with neurodeficit
- Concomitant severe non survivable injury
- Pregnant, or a positive pregnancy test
- Women who intend to breastfeed during Study Days 1-4.
- Blood glucose \<50mg/dL
- Severe renal disorder from the patient's history (e.g. dialysis) or serum creatinine of \> 2.5 mg/dL
- Severe liver disease or total bilirubin \>1.5 times upper limit of normal
- INR\>1.4
- Systolic BP\<90 mm Hg not responsive to fluid resuscitation
- Blood alcohol \> 250mg/dL
- Inability to have MRI (pacemaker, non-MR compatible pressure monitor, etc.)
- Hospitalization for brain injury, psychiatric or neurological disease within previous 3 years
- Emergent or urgent surgical operation anticipated (in OR, bedside procedures excluded) that would prevent dosing with study drug within 8 hours of injury.
- Known use of Coumadin (warfarin), Plavix (clopidogrel), Effient (prasugrel) or Pletal (cilostazol), heparin, low molecular weight heparin, heparinoids, or abciximab or similar antiplatelet agents in the previous 72 hours (Note that patients later found to have taken these medications will not be automatically excluded from the study.)
- Use of sulfonylurea drugs within the prior 30 days
- Treatment with another investigational drug within the prior 30 days
- Allergy to sulfonylurea drugs
- Known diagnosis of G6PD enzyme deficiency
- PaO2 \< 60 mm Hg on admission (for patients in whom blood gases are drawn per standard of care)
- Non-English speaking legally authorized representative and subjects (University of Maryland only)
- Prisoners or others who may be unable to make a truly voluntary and uncoerced decision whether or not to participate in the study
- Any other clinical condition which in the opinion of the investigator makes the patient unsuitable for inclusion into the study
Key Trial Info
Start Date :
December 17 2011
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 20 2015
Estimated Enrollment :
29 Patients enrolled
Trial Details
Trial ID
NCT01454154
Start Date
December 17 2011
End Date
February 20 2015
Last Update
November 12 2024
Active Locations (4)
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1
University of California, San Diego
San Diego, California, United States, 92103
2
University of Maryland Medical Center, Shock Trauma Center
Baltimore, Maryland, United States, 21201
3
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
4
VCU Medical Center
Richmond, Virginia, United States, 23298