A Phase 2 interventional study of Allopregnanolone injection and Placebo injection in Traumatic Brain Injury and Posttraumatic Epilepsy, sponsored by Michael A. Rogawski, MD, PhD. Completed at 1 site in United States. Open to participants aged 16 Years to 65 Years. Per ClinicalTrials.gov, last updated 2017-06-28.
Sponsored by Michael A. Rogawski, MD, PhD · Phase 2, Interventional, and Treatment
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.
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.
2,113 studies on the registry are indexed under Brain Injuries; 385 are open to participants now.
This study's enrollment of 13 is below the median of 48 across 1,331 interventional studies indexed under Brain Injuries.
Browse Brain Injuries studies →This is the only study on the registry with Michael A. Rogawski, MD, PhD as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Allopregnanolone injection (intravenous solution) continuous infusion for 5 days
Drug: Allopregnanolone injection
Placebo injection (intravenous solution) continuous infusion for 5 days
Drug: Placebo injection
Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
Also known as: 3α,5α-tetrahydroprogesterone, 3α-hydroxy-5α-pregnan-20-one, Product L (allopregnanolone intravenous solution, low dose), Product H (allopregnanolone intravenous solution, high dose)
Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
Also known as: Product P (placebo)
Extended Glasgow Outcome Scale (GOS-E) Score
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.
Time frame: 6 months after injury
| Milestone | Allopregnanolone | Placebo |
|---|---|---|
| Started | 7 | 6 |
| Completed | 7 | 6 |
| Not completed | 0 | 0 |
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.
| GOS-E Score | Allopregnanolone | Placebo |
|---|---|---|
| Extended Glasgow Outcome Scale (GOS-E) Score | 4.2 ± 1.9 | 4.3 ± 1.8 |
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Allopregnanolone | 1/7 (14.3%) | 7/7 (100%) | 7/7 (100%) |
| Placebo | 0/6 (0%) | 6/6 (100%) | 6/6 (100%) |
| Event | Allopregnanolone | Placebo |
|---|---|---|
| Intreased intracranial pressureNervous system disorders | 6/7 | 6/6 |
| HypotensionCardiac disorders | 5/7 | 3/6 |
| Aspiration pneumoniaRespiratory, thoracic and mediastinal disorders | 0/7 | 3/6 |
| Acute respiratory distress syndromeRespiratory, thoracic and mediastinal disorders | 0/7 | 2/6 |
| Epidural hematomaNervous system disorders | 0/7 | 2/6 |
| Leg compartment syndromeMusculoskeletal and connective tissue disorders | 2/7 | 0/6 |
| HemorrhageBlood and lymphatic system disorders | 2/7 | 1/6 |
| HypoxiaRespiratory, thoracic and mediastinal disorders | 1/7 | 1/6 |
| Brain herniation (transtentorial and uncal)Nervous system disorders | 0/7 | 1/6 |
| Event | Allopregnanolone | Placebo |
|---|---|---|
| Intracranial pressure increaseNervous system disorders | 6/7 | 6/6 |
| Cerebral hypoperfusionInjury, poisoning and procedural complications | 5/7 | 4/6 |
| HypotensionVascular disorders | 5/7 | 3/6 |
| Electrocardiogram QTC interval prolongeInvestigations | 2/7 | 4/6 |
| PneumoniaRespiratory, thoracic and mediastinal disorders | 0/7 | 4/6 |
| Pneumonia aspirationRespiratory, thoracic and mediastinal disorders | 0/7 | 3/6 |
| HypertensionVascular disorders | 1/7 | 3/6 |
| AgitationPsychiatric disorders | 3/7 | 2/6 |
| AnemiaBlood and lymphatic system disorders | 0/7 | 2/6 |
| Pulmonary edemaCardiac disorders | 0/7 | 2/6 |
| Age, Continuous(years) | Allopregnanolone | Placebo | Total |
|---|---|---|---|
| Mean | 31.1 ± 13.1 | 26.2 ± 13.5 | 28.8 ± 13.0 |
| Sex: Female, Male(Participants) | Allopregnanolone | Placebo | Total |
|---|---|---|---|
| Female | 0 | 2 | 2 |
| Male | 7 | 4 | 11 |
| Ethnicity (NIH/OMB)(Participants) | Allopregnanolone | Placebo | Total |
|---|---|---|---|
| Hispanic or Latino | 1 | 3 | 4 |
| Not Hispanic or Latino | 6 | 3 | 9 |
| Unknown or Not Reported | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Allopregnanolone | Placebo | Total |
|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 |
| Asian | 0 | 0 | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 |
| Black or African American | 0 | 1 | 1 |
| White | 7 | 5 | 12 |
| More than one race | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 0 |
| TBI Severity(Participants) | Allopregnanolone | Placebo | Total |
|---|---|---|---|
| Moderate | 2 | 0 | 2 |
| Severe | 5 | 6 | 11 |
This study is completed, as verified in May 2017. You cannot join it, but the record below documents what was studied.
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