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Glyburide (RP-1127) for Traumatic Brain Injury (TBI)

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2015 by Remedy Pharmaceuticals, Inc..
Recruitment status was:  Active, not recruiting
U.S. Army Medical Research and Materiel Command
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Information provided by (Responsible Party):
Remedy Pharmaceuticals, Inc. Identifier:
First received: October 11, 2011
Last updated: May 5, 2015
Last verified: May 2015
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).

Condition Intervention Phase
Traumatic Brain Injury
Drug: Glyburide
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Glyburide (RP-1127) for TBI

Resource links provided by NLM:

Further study details as provided by Remedy Pharmaceuticals, Inc.:

Primary Outcome Measures:
  • Change in Edema from Baseline [ Time Frame: 72 hr ]
    Edema [ADC (apparent diffusion coefficient) (mm2/sec); Volume (mm3); FW (free water) (normalized units); ADC_t (apparent diffusion coefficient, tissue) (mm2/sec)] will be assessed by imaging.

  • Change in Hemorrhage from Baseline [ Time Frame: 72 hr ]
    Hemorrhage [Hemorrhagic Burden Index (no units); Number of hemorrhagic lesions; Size of hemorrhagic lesions] will be assessed by imaging.

  • Safety i.e. the incidence of mortality, adverse events, and serious adverse events [ Time Frame: Through 180 Days ]
    Safety will be assessed by a review of the incidence of mortality, adverse events, and serious adverse events, as well as by analysis of relevant laboratory data, blood glucose, and ECG's.

Estimated Enrollment: 100
Study Start Date: November 2011
Estimated Study Completion Date: September 2015
Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: Glyburide
RP-1127 (Glyburide for Injection)
Drug: Glyburide
RP-1127 (Glyburide for Injection) delivered as an approximately 2 minute loading dose followed by 72 hours of continuous infusion.
Other Name: glibenclamide
Placebo Comparator: Placebo
Drug: Placebo
Placebo delivered as an approximately 2 minute loading dose followed by 72 hours of continuous infusion.

Detailed Description:

The primary efficacy objective of this study is to assess whether patients with severe, moderate, or complicated mild TBI administered RP-1127 will show a decrease in MRI-defined edema and/or hemorrhage, compared to patients administered placebo.

The primary safety objective is to assess the safety and tolerability of RP-1127 compared to placebo in patients with severe, moderate, or complicated mild TBI.


Ages Eligible for Study:   18 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Documented closed head TBI
  2. Clearly defined time of injury no more than 10 hours before administration of study drug/placebo
  3. 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.
  4. Age 18-75 years
  5. Patients in whom a dedicated peripheral IV line can be placed for study drug administration
  6. Written consent obtained from legally authorized representative (LAR)

Exclusion Criteria:

  1. No documented TBI or time of impact not certain
  2. Penetrating brain injury
  3. Spinal column instability and/or spinal cord injury with neurodeficit
  4. Concomitant severe non survivable injury
  5. Pregnant, or a positive pregnancy test
  6. Women who intend to breastfeed during Study Days 1-4.
  7. Blood glucose <50mg/dL
  8. Severe renal disorder from the patient's history (e.g. dialysis) or serum creatinine of > 2.5 mg/dL
  9. Severe liver disease or total bilirubin >1.5 times upper limit of normal
  10. INR>1.4
  11. Systolic BP<90 mm Hg not responsive to fluid resuscitation
  12. Blood alcohol > 250mg/dL
  13. Inability to have MRI (pacemaker, non-MR compatible pressure monitor, etc.)
  14. Hospitalization for brain injury, psychiatric or neurological disease within previous 3 years
  15. Emergent or urgent surgical operation anticipated (in OR, bedside procedures excluded) that would prevent dosing with study drug within 8 hours of injury.
  16. 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.)
  17. Use of sulfonylurea drugs within the prior 30 days
  18. Treatment with another investigational drug within the prior 30 days
  19. Allergy to sulfonylurea drugs
  20. Known diagnosis of G6PD enzyme deficiency
  21. PaO2 < 60 mm Hg on admission (for patients in whom blood gases are drawn per standard of care)
  22. Non-English speaking legally authorized representative and subjects (University of Maryland only)
  23. Prisoners or others who may be unable to make a truly voluntary and uncoerced decision whether or not to participate in the study
  24. Any other clinical condition which in the opinion of the investigator makes the patient unsuitable for inclusion into the study
  Contacts and Locations
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Please refer to this study by its identifier: NCT01454154

United States, California
University of California, San Diego
San Diego, California, United States, 92103
United States, Maryland
University of Maryland Medical Center, Shock Trauma Center
Baltimore, Maryland, United States, 21201
United States, Pennsylvania
UPMC Presbyterian Hospital
Pittsburgh, Pennsylvania, United States, 15213
United States, Virginia
VCU Medical Center
Richmond, Virginia, United States, 23298
Sponsors and Collaborators
Remedy Pharmaceuticals, Inc.
U.S. Army Medical Research and Materiel Command
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Principal Investigator: Howard Eisenberg, MD University of Maryland
  More Information

Responsible Party: Remedy Pharmaceuticals, Inc. Identifier: NCT01454154     History of Changes
Other Study ID Numbers: RPI 202
INTRuST-GLY ( Other Identifier: INTRuST Clinical Consortium Coordinating Center )
Study First Received: October 11, 2011
Last Updated: May 5, 2015

Keywords provided by Remedy Pharmaceuticals, Inc.:
Traumatic Brain Injury

Additional relevant MeSH terms:
Wounds and Injuries
Brain Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Hypoglycemic Agents
Physiological Effects of Drugs processed this record on May 25, 2017