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

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. Read our disclaimer for details. Identifier: NCT01454154
Recruitment Status : Unknown
Verified May 2015 by Remedy Pharmaceuticals, Inc..
Recruitment status was:  Active, not recruiting
First Posted : October 18, 2011
Last Update Posted : May 6, 2015
U.S. Army Medical Research and Development Command
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
Information provided by (Responsible Party):
Remedy Pharmaceuticals, Inc.

Brief Summary:
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 or disease Intervention/treatment Phase
Traumatic Brain Injury Drug: Glyburide Drug: Placebo Phase 2

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 100 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Randomized Clinical Trial of Glyburide (RP-1127) for TBI
Study Start Date : November 2011
Actual Primary Completion Date : March 2015
Estimated Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Drug Information available for: Glyburide

Arm Intervention/treatment
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.

Primary Outcome Measures :
  1. 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.

  2. 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.

  3. 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.

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
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

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 identifier (NCT number): NCT01454154

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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 Development Command
INTRuST, Post-Traumatic Stress Disorder - Traumatic Brain Injury Clinical Consortium
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Principal Investigator: Howard Eisenberg, MD University of Maryland, College Park
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Responsible Party: Remedy Pharmaceuticals, Inc. Identifier: NCT01454154    
Other Study ID Numbers: RPI 202
INTRuST-GLY ( Other Identifier: INTRuST Clinical Consortium Coordinating Center )
First Posted: October 18, 2011    Key Record Dates
Last Update Posted: May 6, 2015
Last Verified: May 2015
Keywords provided by Remedy Pharmaceuticals, Inc.:
Traumatic Brain Injury
Additional relevant MeSH terms:
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Brain Injuries
Brain Injuries, Traumatic
Wounds and Injuries
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Craniocerebral Trauma
Trauma, Nervous System
Hypoglycemic Agents
Physiological Effects of Drugs