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NCT01143064 · ClinicalTrials.gov registry record · Phase 3
Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury
A Phase 3 study of Brain Injuries, sponsored by BHR Pharma.
- Completed
- Registry status
- Phase 3
- Development phase
- 1,195
- Enrollment target
- 20
- Study locations
NCT01143064: Completed Phase 3 study of Brain Injuries, sponsored by BHR Pharma.
NCT01143064 is a Phase 3 study of Brain Injuries that has completed, run by BHR Pharma. The registered enrollment target is 1,195 participants, above the 277-participant average among 22 other Brain Injuries trials with a reported enrollment target (331% higher). The trial reports 20 study locations across 13 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT01143064, a Phase 3 study of Brain Injuries, has completed, sponsored by BHR Pharma.
- COMPLETED
- Registry status
- Phase 3
- Development phase
- 1,195 participants
- Enrollment target
- 20
- Study locations
Study 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.
Primary Outcome
The GOS assesses mortality and disability in traumatic brain injury (TBI) patients according to the designation: Good Recovery, Moderate Disability, Severe Disability, Vegetative State or Dead.
Conditions Studied
Interventions
- DRUG Progesterone
- DRUG Lipid emulsion without progesterone
Study Locations (20)
Florida
- Delray Medical Center - Delray Beach
- Tallahassee Memorial Healthcare - Tallahassee
- Tampa General Hospital - Tampa
Illinois
- John H. Stroger Jr. Hospital of Cook County - Chicago
- Advocate Lutheran General Hospital - Park Ridge
- Saint John's Hospital - Springfield
California
- LAC+USC Medical Center - Los Angeles
- University of California San Diego Medical Center - San Diego
Indiana
- Wishard Health Services - Indianapolis
- Methodist Hospital - Indianapolis
Iowa
- Mercy Medical Center - Des Moines
- University of Iowa Hospitals and Clinics - Iowa City
Alabama
- University of South Alabama Medical Center - Mobile
Colorado
- Denver Health Medical Center - Denver
Delaware
- Christiana Care Health System Hospital - Newark
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 1,195 participants |
| Start Date | 2010-06 |
| Est. Completion | 2014-03 |
| Phase | Phase 3 |
What the finished NCT01143064 record still lists
NCT01143064 is an interventional study that assigns participants to a tested intervention. Its 1,195 participants enrollment target places it among the larger protocols in the corpus, above the 277-participant average among 22 other Brain Injuries trials with a reported enrollment target (331% higher).
The record links to 1 condition, with Brain Injuries appearing as the primary indexed condition, and to 2 interventions - of which Progesterone is the first listed.
NCT01143064 names 20 study sites across 13 states, led by Florida, Illinois, California.
Frequently Asked Questions
What is clinical trial NCT01143064 about?
NCT01143064 is a clinical study titled "Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury". 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.
What is the current status of trial NCT01143064?
This trial is currently completed. It is a Phase 3 study. The enrollment target is 1,195 participants. The study started on 2010-06. Estimated completion is 2014-03.
What conditions does trial NCT01143064 study?
This clinical trial studies the following conditions: Brain Injuries.
What interventions are being tested in trial NCT01143064?
The interventions under investigation include: Progesterone (DRUG), Lipid emulsion without progesterone (DRUG).
Who is sponsoring clinical trial NCT01143064?
This trial is sponsored by BHR Pharma, which has 3 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT01143064 being conducted?
This trial has 20 study locations across Alabama, California, Colorado, Delaware, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
Similar trials for Brain Injuries
Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.
Where NCT01143064's enrollment target sits among peer trials
1,195 2nd of 22 the highest of 22 other Brain Injuries trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Brain Injuries trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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