Glyburide (RP-1127) for Traumatic Brain Injury (TBI)
|Study Design:||Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
|Official Title:||A Randomized Clinical Trial of Glyburide (RP-1127) for TBI|
- Change in Edema from Baseline [ Time Frame: 72 hr ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: No ]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 ] [ Designated as safety issue: Yes ]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.
|Study Start Date:||November 2011|
|Estimated Study Completion Date:||September 2015|
|Primary Completion Date:||March 2015 (Final data collection date for primary outcome measure)|
Active Comparator: Glyburide
RP-1127 (Glyburide for Injection)
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
Placebo delivered as an approximately 2 minute loading dose followed by 72 hours of continuous infusion.
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.
Please refer to this study by its ClinicalTrials.gov 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|
|Principal Investigator:||Howard Eisenberg, MD||University of Maryland|