At a glance
ClinicalIndex Comparison RecordPhase 3Completed· 1,195 enrolled
Drug / intervention
Progesterone +1 moredrug
Likely dose
Progesterone 0.71mg/kgfrom 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 Randomized, Double-Blind, Placebo-Controlled Phase 3 Study to Investigate the Efficacy and Safety of Progesterone in Patients With Severe Traumatic Brain Injury
In Brief
A Phase 3 clinical trial evaluating Progesterone and Lipid emulsion without progesterone for Brain Injuries. Completed, enrolled 1,195 participants across 156 sites in 21 countries.
Detailed Summary
The SyNAPSe trial will study if giving intravenous (i.v.) progesterone within 8 hours of the injury for a total of 120 hours to severe traumatic brain injury patients improves their recovery.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBrain Injuries
CountriesArgentina, Austria, Belgium, China, Czechia, Finland, France, Germany, Hungary, Israel, Italy, Malaysia, Netherlands, Romania, Russia, Singapore, Spain, Taiwan, Thailand, United Kingdom, United States
CollaboratorsPRA Health Sciences, Syneos Health
Timeline
Phase 3CompletedFinished
20102011201220132014201520162017201820192020202120222023202420252026
Enrollment StartJun 2010
First PostedJun 2010
Primary CompletionMar 2014
TodayJul 2026
First PostedJun 14, 2010
Enrollment StartJun 1, 2010
Primary CompletionMar 1, 2014
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 16.1 years ago
Interventions
Progesteronedrug
Intravenous administration of 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.
Lipid emulsion without progesteronedrug
Intravenous administration equal to 0.71mg/kg/hr for 1hr followed by 0.5mg/kg/hr administered intravenously for an additional 119 hrs.