Sex Hormone Now In Phase III Trials As Treatment For Traumatic Brain Injury
Traumatic Brain Injury (TBI), generally results from a severe blow to the head, brought on by hitting, being hit, or falling on one's head. Many soldiers, particularly in the Iraq and Afghanistan wars, are victims of TBI, as a result of being struck by projectiles in battle. When such a blow occurs, the brain is literally rattled for a time by the force of the impact.
Short-term, the disruption can affect thinking, language, learning, vision, hearing, motor skills, emotions, and can even bring on additional disorders of the brain, such as epilepsy. But these disturbances may become long-term and even worsen, if the patient is not treated immediately.
Several drugs are currently used to minimize the impact of TBI; the precise one(s) prescribed often depend on the symptoms expressed. But 25 years of research on a biologically available hormone, progesterone, is finally in Phase III trials, having shown promise for early-identified and early-treated TBI patients, regardless of the specific symptoms.
Progesterone, often called the "pregnancy hormone," plays a big role in menstruation, pregnancy, and the development of the fetus right through birth. But progesterone has other roles as well, including nurturing of the brain.
It was Emory University's Dr. Asa G. Candler, Professor of Emergency Medicine and Donald G. Stein, PhD, who first discovered the neuro-protective role of progesterone 25 years ago. Dr. David Wright, Associate Professor of Emergency Medicine, is also at Emory, and he and his team have continued research on progesterone, infusing it into the brains of TBI animal models and in a small sample of human TBI subjects.
In the latter study (ProTECT I) researchers found evidence that the form of progesterone injected was a safe and effective treatment for patients with TBI. It reduced patient mortality by 50 percent and reduced disabilities and functional outcomes for patients with moderate brain injury, something no other drug had done before.
Phase III, aka ProTECT III, will begin in March, 2010 at 17 medical centers across the country. Phase III clinical trials will be a randomized, double-blind study, involving approximately 1,140 patients over a three-to-six year period using the hormone progesterone to treat TBI. The National Institutes of Health (NIH) is funding the grant, which was awarded to Emory University.