Traumatic Brain Injury Clinical Trial
Official title:
A Double-blind, Placebo-controlled, Randomized Clinical Trial of Allopregnanolone for the Treatment of Traumatic Brain Injury
This study will provide initial data on the safety and effectiveness of allopregnanolone in improving neurobehavioral outcome and reducing mortality in adults with moderate and severe traumatic brain injury.
Status | Completed |
Enrollment | 13 |
Est. completion date | July 2016 |
Est. primary completion date | May 2015 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 16 Years to 65 Years |
Eligibility |
Inclusion Criteria: - English or Spanish speaking person - Moderate to severe closed or blunt traumatic brain injury [post resuscitation Glasgow Coma Score (GCS) 3-12 with abnormal head CT scan if GCS is 9-12] - Less than 8 hours from injury to study initiation - Able to participate for the full term of the study Exclusion Criteria: - Subjects with life expectancy of less than 24 hours - Isolated epidural hematoma - Hypoxia (pulse oximetry saturation =90% for 15 or more minutes before enrollment) - Hypotension (systolic blood pressure =90 mm Hg on 2 or more reliable measurements before enrollment) - Cardiopulmonary arrest prior to randomization - Spinal cord injury with motor deficits - Bilateral non-reactive pupils with Glasgow Coma Scale 3 - Body weight >120 kg - Pregnancy - Active breast or reproductive organ cancer - Allergy to progesterone - History of thromboembolic events - Receipt of activated Factor VII before enrollment - Any disease that is unstable or which could jeopardize the safety of the subject including severe renal impairment (creatinine clearance <50 ml/min) - Prisoner/ward of the state - Known treatment with another investigational drug therapy or procedure within 30 days of injury |
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment
Country | Name | City | State |
---|---|---|---|
United States | University of Southern California | Los Angeles | California |
United States | University of California, Davis Medical Center | Sacramento | California |
United States | University of California, San Diego | San Diego | California |
United States | University of California, San Francisco | San Francisco | California |
Lead Sponsor | Collaborator |
---|---|
University of California, Davis | United States Department of Defense |
United States,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Extended Glasgow Outcome Scale (GOS-E) Score | GOS-E assessed by structured interview | 3 months after injury | No |
Secondary | Mortality | Determination of mortality based on interviews with participant family members or a national death certificate search | 3 months after injury | No |
Secondary | Depression | Patient Health Questionaire (PHQ-9) assessed by structured interview | 3 months after injury | No |
Secondary | Late Posttraumatic Epilepsy | Presence of posttraumatic epilepsy assessed by structured interview | 3 months after injury | No |
Secondary | Mortality | Determination of mortality based on interviews with participant family members or a national death certificate search | 6 months after injury | No |
Secondary | Extended Glasgow Outcome Scale (GOS-E) Score | GOS-E assessed by structured interview | 6 months after injury | No |
Secondary | Neurobehavioral Rating Scale Revised (NRS-R) | NRS-R assessed by structured interview | 6 months after injury | No |
Secondary | Test of Adult Reading | Wechsler Test of Adult Reading (WTAR) assessed by structured interview | 6 months after injury | No |
Secondary | Tests of Executive Function | Delis-Kaplan Executive Function System (D-KEFS) Verbal Fluency and Color Word Interference, and Halstead-Reitan Battery Trails B, assessed by structured interview | 6 months after injury | No |
Secondary | Tests of Learning, Delayed Recall, and Recognition | Hopkins Verbal Learning-Revised (HVLT-R) and Brief Visual Memory Test-Revised (BVMT-R), assessed by structured interview | 6 months after injury | No |
Secondary | Test of Working Memory | Wechsler Adult Intelligence Scale-III (WAISIII) Number-Letter Sequencing assessed by structured interview | 6 months after injury | No |
Secondary | Tests of Psychomotor and Processing Speed | Symbol Digit Modalities Test (SDMT), Halstead-Reitan Battery Trails A, Grooved Pegboard, Simple Selection Attention Task (SSAT) and Complex Selection Attention Task (CSAT), assessed by structured interview | 6 months after injury | No |
Secondary | Depression | Patient Health Questionaire (PHQ-9) assessed by structured interview | 6 months after injury | No |
Secondary | Quality of Life | Short-form (SF-36) health survey assessed by structured interview | 6 months after injury | No |
Secondary | Late Posttraumatic Epilepsy | Presence of posttraumatic epilepsy assessed by structured interview | 6 months after injury | No |
Secondary | Late Posttraumatic Epilepsy | Presence of posttraumatic epilepsy assessed by structured interview | 12 months after injury | No |
Secondary | Anxiety | Beck Anxiety Inventory assessed by structure interview | 6 months after injury | No |
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