Overview

This trial is active, not recruiting.

Condition traumatic brain injury
Treatments glyburide, placebo
Phase phase 2
Sponsor Remedy Pharmaceuticals, Inc.
Collaborator U.S. Army Medical Research and Materiel Command
Start date November 2011
End date March 2015
Trial size 100 participants
Trial identifier NCT01454154, INTRuST-GLY, RPI 202

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).

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Active Comparator)
RP-1127 (Glyburide for Injection)
glyburide glyburide
RP-1127 (Glyburide for Injection) delivered as an approximately 2 minute loading dose followed by 72 hours of continuous infusion.
(Placebo Comparator)
Placebo
placebo
Placebo delivered as an approximately 2 minute loading dose followed by 72 hours of continuous infusion.

Primary Outcomes

Measure
Change in Edema from Baseline
time frame: 72 hr
Change in Hemorrhage from Baseline
time frame: 72 hr
Safety i.e. the incidence of mortality, adverse events, and serious adverse events
time frame: Through 180 Days

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

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

Additional Information

Official title A Randomized Clinical Trial of Glyburide (RP-1127) for TBI
Principal investigator Howard Eisenberg, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in May 2015.
Information provided to ClinicalTrials.gov by Remedy Pharmaceuticals, Inc..