Efficacy and Safety Study of Intravenous Progesterone in Patients With Severe Traumatic Brain Injury

Completed · Phase 3

Conditions studied: Brain Injuries

In brief

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.

Key facts

Study ID

NCT01143064

Run by

BHR Pharma, LLC

People needed

1195

Starts

2010-06-01

Expected to finish

2014-03-01

Last updated by the study team

2024-10-02

Who can join

Age: 16 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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)

Where it is running

• LAC+USC Medical Center — Los Angeles, California, United States
• University of California San Diego Medical Center — San Diego, California, United States
• Denver Health Medical Center — Denver, Colorado, United States
• Christiana Care Health System Hospital — Newark, Delaware, United States
• Delray Medical Center — Delray Beach, Florida, United States
• Tallahassee Memorial Healthcare — Tallahassee, Florida, United States
• Tampa General Hospital — Tampa, Florida, United States
• Saint Alphonsus Regional Medical Center — Boise, Idaho, United States
• John H. Stroger Jr. Hospital of Cook County — Chicago, Illinois, United States
• Advocate Lutheran General Hospital — Park Ridge, Illinois, United States
• Saint John's Hospital — Springfield, Illinois, United States
• Wishard Health Services — Indianapolis, Indiana, United States
• Methodist Hospital — Indianapolis, Indiana, United States
• Mercy Medical Center — Des Moines, Iowa, United States
• University of Iowa Hospitals and Clinics — Iowa City, Iowa, United States
• University of Kansas Medical Center — Kansas City, Kansas, United States
• University of Louisville Hospital — Louisville, Kentucky, United States
• LSU Health - Shreveport — Shreveport, Louisiana, United States
• Eastern Maine Medical Center — Bangor, Maine, United States
• Maine Medical Center — Portland, Maine, United States
• Baystate Medical Center — Springfield, Massachusetts, United States
• University of Massachusetts Memorial Medical Center — Worcester, Massachusetts, United States
• Bronson Methodist Hospital — Kalamazoo, Michigan, United States
• St. Mary's of Michigan — Saginaw, Michigan, United States
• University of South Alabama Medical Center — Mobile, Alabama, United States

Full record on ClinicalTrials.gov

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