Trial Outcomes & Findings for Allopregnanolone for the Treatment of Traumatic Brain Injury (NCT NCT01673828)
NCT ID: NCT01673828
Last Updated: 2017-06-28
Results Overview
GOS-E is a global scale for functional outcome that rates patient status into one of 8 levels. The minimum score is 1 and the maximum score is 8. 1 = dead; 2 = vegetative state; 3 = low severe disability; 4 = upper severe disability; 5 = low moderate disability; 6 = upper moderate disability; 7 = low good recovery; 8 = upper good recovery. GOS-E was assessed by 19 question structured interview.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
13 participants
Primary outcome timeframe
6 months after injury
Results posted on
2017-06-28
Participant Flow
Participant milestones
| Measure |
Allopregnanolone
Allopregnanolone injection (intravenous solution) continuous infusion for 5 days
Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
|
Placebo
Placebo injection (intravenous solution) continuous infusion for 5 days
Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
|
|---|---|---|
|
Overall Study
STARTED
|
7
|
6
|
|
Overall Study
COMPLETED
|
7
|
6
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Allopregnanolone for the Treatment of Traumatic Brain Injury
Baseline characteristics by cohort
| Measure |
Allopregnanolone
n=7 Participants
Allopregnanolone injection (intravenous solution) continuous infusion for 5 days
Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
|
Placebo
n=6 Participants
Placebo injection (intravenous solution) continuous infusion for 5 days
Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
|
Total
n=13 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
31.1 years
STANDARD_DEVIATION 13.1 • n=5 Participants
|
26.2 years
STANDARD_DEVIATION 13.5 • n=7 Participants
|
28.8 years
STANDARD_DEVIATION 13.0 • n=5 Participants
|
|
Sex: Female, Male
Female
|
0 Participants
n=5 Participants
|
2 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
6 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
7 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
TBI Severity
Moderate
|
2 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
TBI Severity
Severe
|
5 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 6 months after injuryGOS-E is a global scale for functional outcome that rates patient status into one of 8 levels. The minimum score is 1 and the maximum score is 8. 1 = dead; 2 = vegetative state; 3 = low severe disability; 4 = upper severe disability; 5 = low moderate disability; 6 = upper moderate disability; 7 = low good recovery; 8 = upper good recovery. GOS-E was assessed by 19 question structured interview.
Outcome measures
| Measure |
Allopregnanolone
n=7 Participants
Allopregnanolone injection (intravenous solution) continuous infusion for 5 days
Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
|
Placebo
n=6 Participants
Placebo injection (intravenous solution) continuous infusion for 5 days
Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
|
|---|---|---|
|
Extended Glasgow Outcome Scale (GOS-E) Score
|
4.2 GOS-E Score
Standard Deviation 1.9
|
4.3 GOS-E Score
Standard Deviation 1.8
|
Adverse Events
Allopregnanolone
Serious events: 7 serious events
Other events: 7 other events
Deaths: 1 deaths
Placebo
Serious events: 6 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Allopregnanolone
n=7 participants at risk
Allopregnanolone injection (intravenous solution) continuous infusion for 5 days
Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
|
Placebo
n=6 participants at risk
Placebo injection (intravenous solution) continuous infusion for 5 days
Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
|
|---|---|---|
|
Musculoskeletal and connective tissue disorders
Leg compartment syndrome
|
28.6%
2/7 • Number of events 2
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
|
Nervous system disorders
Epidural hematoma
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
|
Blood and lymphatic system disorders
Hemorrhage
|
28.6%
2/7 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Hypotension
|
71.4%
5/7 • Number of events 5
|
50.0%
3/6 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Aspiration pneumonia
|
0.00%
0/7
|
50.0%
3/6 • Number of events 3
|
|
Nervous system disorders
Intreased intracranial pressure
|
85.7%
6/7 • Number of events 6
|
100.0%
6/6 • Number of events 6
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Brain herniation (transtentorial and uncal)
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
Other adverse events
| Measure |
Allopregnanolone
n=7 participants at risk
Allopregnanolone injection (intravenous solution) continuous infusion for 5 days
Allopregnanolone injection: Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
|
Placebo
n=6 participants at risk
Placebo injection (intravenous solution) continuous infusion for 5 days
Placebo injection: Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
|
Blood and lymphatic system disorders
Jaundice
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Cardiac disorders
Bradycardia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Cardiac disorders
Ischemic cardiomyopathy
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Cardiac disorders
Pulmonary edema
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
|
Cardiac disorders
Tachycardia
|
14.3%
1/7
|
0.00%
0/6
|
|
Eye disorders
Conjunctival edema
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Hypothermia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Necrosis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
General disorders
Pyrexia
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
General disorders
Alcohol withdrawal symptom
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Cellulitis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Fungal infection
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
|
Infections and infestations
Infection
|
28.6%
2/7 • Number of events 2
|
0.00%
0/6
|
|
Infections and infestations
Respiratory tract infection
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Infections and infestations
Staphylococcal sepsis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Infections and infestations
Urinary tract infection
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Injury, poisoning and procedural complications
Cerebral hypoperfusion
|
71.4%
5/7 • Number of events 5
|
66.7%
4/6 • Number of events 4
|
|
Investigations
Central venous pressure decrease
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Investigations
Electrocardiogram QTC interval prolonge
|
28.6%
2/7 • Number of events 2
|
66.7%
4/6 • Number of events 4
|
|
Investigations
Electrocardiogram ST segment elevation
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Electrocardiogram T wave inversion
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Investigations
Internation normalized ratio increase
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Diabetes insipidus
|
28.6%
2/7 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Metabolism and nutrition disorders
Hypervolemia
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
|
Metabolism and nutrition disorders
Hyponatremia
|
28.6%
2/7 • Number of events 2
|
0.00%
0/6
|
|
Musculoskeletal and connective tissue disorders
Compartment syndrome
|
28.6%
2/7 • Number of events 2
|
0.00%
0/6
|
|
Nervous system disorders
Autonomic nervous system imbalance
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Craniocerebral injury
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Headache
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Intracranial pressure increase
|
85.7%
6/7 • Number of events 6
|
100.0%
6/6 • Number of events 6
|
|
Nervous system disorders
Meningitis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Neuralgia
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Nervous system disorders
Spinal epidural hematoma
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
|
Psychiatric disorders
Agitation
|
42.9%
3/7 • Number of events 3
|
33.3%
2/6 • Number of events 2
|
|
Nervous system disorders
Drug withdrawal syndrome
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Renal and urinary disorders
Polyuria
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Acute respiratory distress syndrome
|
0.00%
0/7
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Bronchospasm
|
14.3%
1/7 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
14.3%
1/7 • Number of events 1
|
16.7%
1/6 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia
|
0.00%
0/7
|
66.7%
4/6 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia aspiration
|
0.00%
0/7
|
50.0%
3/6 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonia staphylococcal
|
14.3%
1/7 • Number of events 1
|
33.3%
2/6 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
28.6%
2/7 • Number of events 2
|
0.00%
0/6
|
|
Respiratory, thoracic and mediastinal disorders
Sinusitis
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Skin and subcutaneous tissue disorders
Eschar
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Rash
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
|
Vascular disorders
Deep vein thrombosis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hemorrhage
|
28.6%
2/7 • Number of events 2
|
16.7%
1/6 • Number of events 1
|
|
Vascular disorders
Hypertension
|
14.3%
1/7 • Number of events 1
|
50.0%
3/6 • Number of events 3
|
|
Vascular disorders
Hypotension
|
71.4%
5/7 • Number of events 5
|
50.0%
3/6 • Number of events 3
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary embolism/deep vein thrombosis
|
0.00%
0/7
|
16.7%
1/6 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Sacrum ulcer
|
14.3%
1/7 • Number of events 1
|
0.00%
0/6
|
Additional Information
Dr. Michael Rogawski
Department of Neurology, School of Medicine, University of California, Davis
Phone: 916-734-6285
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place