This is a randomized, double-blind, placebo-controlled, multi-institutional study of IV
RP-1127 (Glyburide for Injection) begun within 10 hours of complicated mild, moderate or
severe traumatic brain injury (TBI).
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Locations near you
Unfortunately, there are no recruiting locations near you. Please check the list with all locations below.
Full eligibility criteria for NCT01454154
Ages eligible for Study
18 Years to 75 Years
Genders eligible for Study
Accepts Healthy Volunteers
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)
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
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
All locations for NCT01454154
United States (4)
University of California, San Diego
San Diego, California, United States, 92103
University of Maryland Medical Center, Shock Trauma Center
Baltimore, Maryland, United States, 21201
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
VCU Medical Center
Richmond, Virginia, United States, 23298
View full eligibility
Tris trial is registered with FDA with number: NCT01454154. The sponsor of the trial is Remedy Pharmaceuticals, Inc. and it is looking for 100 volunteers for the current phase.
Official trial title: A Randomized Clinical Trial of Glyburide (RP-1127) for TBI
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