Traumatic brain injury (TBI) is a major cause of premature death and disability worldwide. In the U.S. approximately 2 million Americans sustain a TBI, leading to 50,000 deaths and 235,000 hospitalizations annually. The economic toll exceeds 60 billion dollars per year. No therapy has been found to be effective for reducing mortality and improving functional outcomes. Recently, our team completed an NINDS-funded, Phase IIa double-blinded, placebo-controlled pilot clinical trial that examined the pharmacokinetics, safety, and activity of progesterone, a steroid found to have powerful neuroprotective effects in multiple animal models of brain injury. Our pilot study demonstrated a 50% reduction in death among severe TBI patients and less disability among moderate TBI patients treated with progesterone. Based on these promising results and supportive preclinical data, we are conducting a large, phase III clinical trial (ProTECT III) to definitively assess the safety and efficacy of this treatment for adults with moderate to severe acute TBI. The study is slated to begin August 2008.
- 1,500,000 mTBIs per year in the U.S.
- Leading cause of disability in soldiers from Iraq and Afghanistan
- 50,000 deaths
- 80,000 new cases of long-term disability
- 56 billion dollars annually
- No effective drug treatment