At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 13 enrolled
Drug / intervention
Allopregnanolone injection +1 moredrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Double-blind, Placebo-controlled, Randomized Clinical Trial of Allopregnanolone for the Treatment of Traumatic Brain Injury
In Brief
A Phase 2 clinical trial evaluating Allopregnanolone injection and Placebo injection for Traumatic Brain Injury and Posttraumatic Epilepsy. Completed, enrolled 13 participants across 1 site.
Detailed 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.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsTraumatic Brain Injury, Posttraumatic Epilepsy
CountriesUnited States
CollaboratorsUnited States Department of Defense
Timeline
Phase 2CompletedFinished
20132014201520162017201820192020202120222023202420252026
First PostedAug 2012
Enrollment StartApr 2013
Primary CompletionMay 2015
Study CompletionJul 2016
TodayJul 2026
First PostedAug 28, 2012
Enrollment StartApr 1, 2013
Primary CompletionMay 1, 2015
Study CompletionJul 1, 2016
TodayJul 2, 2026
Enrollment to primary: 2.1 yearsPosted 13.8 years ago
Interventions
Allopregnanolone injectiondrug
Allopregnanolone intravenous solution in 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium
Placebo injectiondrug
Placebo intravenous solution, 0.9% sodium chloride injection with 6% sulfobutyl ether β-cyclodextrin sodium