A clinical trial of a new neuroprotective drug for people with traumatic brain injuries will be offered to patients seen in UC Davis Medical Center's level-1 trauma center, through an $8 million grant funded by the Congressionally Directed Medical Research Program of the U.S. Department of Defense.
The study's primary aim is to determine whether the drug, a neuroactive steroid called allopregnanolone, would be an effective treatment for severe brain injuries such as those occurring in car crashes, sports and recreation accidents and falls. Active duty military personnel in war zones also experience severe brain injury as a result of blasts from the explosion of makeshift bombs or improvised explosive devices.
The study will take place over five years and will be led by Michael Rogawski, professor and chair of the Department of Neurology in the UC Davis School of Medicine, who is highly regarded for developing new drug treatments for patients with epilepsy.
"Allopregnanolone has never been tested in humans with brain injuries but it has been shown to be effective in animal models," Rogawski said. "We believe that this approach can provide patients with improved survival and cognition and better overall neurological outcomes. We also will be looking to see if it prevents the development of post-traumatic epilepsy."
"Post-traumatic epilepsy is a major complication of traumatic brain injury that is associated with psychosocial disability and may be a contributing factor to premature death after head injury," Rogawski said. "The incidence of post-traumatic epilepsy is 10 to 15 percent for adults with severe brain injuries and has been as high as 50 percent in the military."
Allopregnanolone is a steroid that protects against seizures and brain injury. It is produced in the body from the female sex hormone progesterone. Recently, progesterone has been studied and found promising for treating brain injury in humans. But it is difficult to formulate and administer and produces hormonal side effects, Rogawski said. In animals, allopregnanolone is more potent than progesterone in treating traumatic brain injury and it does not have progesterone's hormonal activity, he said.