Talking points for the introduction to families regarding the study
- This study will involve randomly assigning treatment with a progesterone infusion or placebo for 5 days. A placebo looks like the active study drug but has no active ingredient. “Randomly assigned” means that the treatment you receive will be decided by chance (like flipping a coin).
- This is an investigational drug which means it is not approved by the U.S. Food and Drug Administration.
- This study drug, called BHR-100, may improve recovery by limiting damage to the brain and central nervous system. Progesterone is a naturally produced hormone in men and women and is an important agent affecting many functions in the central nervous system. It may play an important role in improving repair after a traumatic brain injury.
- Progesterone for the treatment of traumatic brain injury has been tested in three human studies. In these studies, the only side effect due to progesterone was inflammation of the vein at the IV site in one subject, and this did not require medical treatment. Benefits included: limit central nervous system damage, reduces loss of neural tissue and improves functional recovery.
- These three studies used various mixtures of progesterone. The mixture of progesterone in BHR-100 has not yet been studied in subjects with severe traumatic brain injury.
- All subjects will receive standard medical care during the study.
- The main goal of this study is to determine the degree of recovery 6 months following the brain injury.
- Another main goal of this study is to determine the safety of receiving BHR-100 after a traumatic brain injury.
- Your condition may or may not improve while you are in this study. Even if you receive no benefits, the results of this study may help people in the future who suffer from a traumatic brain injury.
BHR 100-301 Closed Head Trauma Study