Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01673828
Other study ID # DR081314
Secondary ID
Status Completed
Phase Phase 2
First received August 20, 2012
Last updated October 28, 2016
Start date April 2013
Est. completion date July 2016

Study information

Verified date October 2016
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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.


Description:

This is a double-blind, placebo-controlled, randomized, dose-finding, two-stage adaptive, clinical trial study comparing allopregnanolone to placebo when administered intravenously for 5 days beginning within 8 hours after injury. Test products to be administered are low and high dose allopregnanolone (Products L and H, respectively) and placebo (Product P) intravenous solutions. The products are administered during a 4-day treatment period followed by a 1-day dose de-escalation period. Stage 1 of the study will assess safety and confirm that dosing with Products L and H achieve the target steady-state plasma concentrations set for each of these products. Dosing will be adjusted in Stage 1, if necessary. Stage 2 will initially allocate subjects equally to Products L, H and P but will then use adaptive randomization to allocate subjects between Products L and H to optimized the probability of yielding a better 3-month Glasgow Outcome Score Extended (GOS-E) score.


Recruitment information / eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Intervention

Drug:
Allopregnanolone injection
Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether ß-cyclodextrin sodium
Placebo injection
Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether ß-cyclodextrin sodium

Locations

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

Sponsors (2)

Lead Sponsor Collaborator
University of California, Davis United States Department of Defense

Country where clinical trial is conducted

United States, 

Outcome

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
See also
  Status Clinical Trial Phase
Terminated NCT03052712 - Validation and Standardization of a Battery Evaluation of the Socio-emotional Functions in Various Neurological Pathologies N/A
Recruiting NCT05503316 - The Roll of Balance Confidence in Gait Rehabilitation in Persons With a Lesion of the Central Nervous System N/A
Completed NCT04356963 - Adjunct VR Pain Management in Acute Brain Injury N/A
Completed NCT03418129 - Neuromodulatory Treatments for Pain Management in TBI N/A
Terminated NCT03698747 - Myelin Imaging in Concussed High School Football Players
Recruiting NCT05130658 - Study to Improve Ambulation in Individuals With TBI Using Virtual Reality -Based Treadmill Training N/A
Recruiting NCT04560946 - Personalized, Augmented Cognitive Training (PACT) for Service Members and Veterans With a History of TBI N/A
Completed NCT05160194 - Gaining Real-Life Skills Over the Web N/A
Recruiting NCT02059941 - Managing Severe Traumatic Brain Injury (TBI) Without Intracranial Pressure Monitoring (ICP) Monitoring Guidelines N/A
Recruiting NCT03940443 - Differences in Mortality and Morbidity in Patients Suffering a Time-critical Condition Between GEMS and HEMS
Recruiting NCT03937947 - Traumatic Brain Injury Associated Radiological DVT Incidence and Significance Study
Completed NCT04465019 - Exoskeleton Rehabilitation on TBI
Recruiting NCT04530955 - Transitioning to a Valve-Gated Intrathecal Drug Delivery System (IDDS) N/A
Recruiting NCT03899532 - Remote Ischemic Conditioning in Traumatic Brain Injury N/A
Suspended NCT04244058 - Changes in Glutamatergic Neurotransmission of Severe TBI Patients Early Phase 1
Completed NCT03307070 - Adapted Cognitive Behavioral Treatment for Depression in Patients With Moderate to Severe Traumatic Brain Injury N/A
Recruiting NCT04274777 - The Relationship Between Lipid Peroxidation Products From Traumatic Brain Injury and Secondary Coagulation Disorders
Withdrawn NCT05062148 - Fundamental and Applied Concussion Recovery Modality Research and Development: Applications for the Enhanced Recovery N/A
Withdrawn NCT04199130 - Cognitive Rehabilitation and Brain Activity of Attention-Control Impairment in TBI N/A
Withdrawn NCT03626727 - Evaluation of the Efficacy of Sodium Oxybate (Xyrem®) in Treatment of Post-traumatic Narcolepsy and Post-traumatic Hypersomnia Early Phase 1