Phase 3
N=1,195
Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
Brain Injuries
Bottom Line
View on ClinicalTrials.gov: NCT01143064 ↗Enrolled (actual)
1,195
Serious AEs
37.2%
Results posted
Oct 2024
Primary outcome: Primary: Glasgow Outcome Scale (GOS) — 189; 183; 109; 114 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Progesterone (Drug); Lipid emulsion without progesterone (Drug)
- Age
- Pediatric, Adult, Older Adult · 16+ yrs
- Sex
- All
- Sponsor
- BHR Pharma, LLC
- Primary completion
- Mar 2014
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Glasgow Outcome Scale (GOS) |
189; 183; 109; 114; 162; 160 | — |
| SECONDARY Mortality at Month 1 |
0; 0; 0; 0; 500; 507 | — |
| SECONDARY Mortality at Month 6 |
0; 2; 0; 0; 463; 472 | — |
| SECONDARY Glasgow Outcome Scale at 3 Months |
103; 101; 103; 114; 224; 216 | — |
| SECONDARY Glasgow Outcome Scale - Extended (GOS-E) |
102; 88; 33; 49; 173; 165 | — |
| SECONDARY Short Form (36) Health Survey (SF-36) |
39.8; 40.6; 44.6; 45.1; 48.7; 48.5 | — |
| SECONDARY Potentially Clinically Important On-Treatment Cerebral Perfusion Pressure (CPP) and Summary of Maximum Therapy Therapeutic Intensity Level (TIL) |
130; 155; 297; 299; 448; 460 | — |
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.
Eligibility Criteria
Inclusion Criteria
- Male or female patients between the age of 16 and 70 years, inclusive
- Weight from 45 to 135 kg, inclusive
- Sustained a closed head trauma no more than 8 hours before start of study drug infusion
- TBI diagnosed by history and clinical examination
- Post-resuscitation Glasgow Coma Scale (GCS) score between 3 to 8, inclusive
- At least one reactive pupil (pinpoint pupils due to opioid pain treatment are considered reactive)
- Evidence of TBI confirmed by abnormalities consistent with trauma on CT scan upon admission (diffuse injury II-IV, evacuated and non-evacuated mass lesion, Marshall's CT Classification)
- Indication for ICP monitoring
Exclusion Criteria
- Life expectancy of less than 24 hours as determined by the Investigator
- Prolonged and/or uncorrectable hypoxia (Pa02< 60 mmHg) or hypotension (systolic blood pressure < 90 mmHg) at the time of randomization
- Any spinal cord injury
- Pregnancy
- Penetrating head injury
- Bilaterally fixed dilated pupils at the time of randomization
- Coma suspected to be primarily due to other causes (e.g. alcohol)
- Pure epidural hematoma
- Preexisting clinically significant disease or chronic condition that can be ascertained at the time of admission and could affect functional outcome
- Severe cardiac or hemodynamic instability prior to randomization
- Known treatment with another investigational drug therapy or procedure within 30 days of injury
- A history of allergic reaction to progesterone and related drugs or any of the components of the infusion
- Any disease, in the opinion of the Investigator, that is unstable or which could jeopardize the safety of the patient and his/her compliance in the study.
- Patients who, in the opinion of the Investigator, would not be able or willing to comply with the protocol through the final visit (6 months post-injury)
Data sourced from ClinicalTrials.gov (NCT01143064). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.