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    Progesterone for Traumatic Brain Injury: Experimental Clinical Treatment: Phase III Clinical Trial

 

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Background of ProTECT III



The Problem: Every 15 seconds, a U.S. citizen sustains a significant traumatic brain injury (TBI). Every five minutes, someone is permanently disabled as a consequence of TBI. Between 1.5 to 2 million Americans sustain a TBI each year. In addition to the 50,000 deaths and 235,000 hospitalizations caused by TBI each year, more than 80,000 Americans are disabled. Approximately 17,000 of them require specialized care for life. Another 37,000 patients experience moderate disabilities. The CDC estimates that 5.3 million civilian Americans are living with some degree of disability from a previous traumatic brain injury. Survivors of severe brain injury (GCS 3-8) typically require 5 to 10 years of intensive therapy. The average per-person lifetime medical care costs of TBI are estimated as follows: moderate $80,800, severe $92,700, and very severe $324,400. However, a single victim of severe TBI can generate $4 million dollars in lifetime costs. Aggregate annual costs of TBI in the U.S. approached $60 billion in 2000.

TBI has been labeled the "signature injury" of the Iraq war. The number of military personnel who fall victim to blunt TBI has risen dramatically due to an increase in the use of concussive weapons coupled with use of body armor that reduces fatal penetrating injuries. In the Iraq/Afghan conflicts, approximately 20% of returning combat personnel have suffered a TBI in theater.

WHY Progesterone: Although progresterone is widely considered a "sex steroid", it is also a potent neurosteroid. Progesterone is naturally synthesized in the CNS. A large and growing body of animal studies indicate that early administration of progesterone after TBI reduces cerebral edema, neuronal loss, and behavioral deficits in laboratory animals. Certain properties of progesterone make it an ideal therapeutic candidate. First, in contrast to most drugs tested to date, progesterone rapidly enters the brain and reaches equilibrium with the plasma within an hour of administration. Second, unlike other experimental agents, progesterone has a long history of safe use in humans66-70. Finally, the findings of our pilot clinical trial (presented in the Preliminary Data Section, below) indicate that progesterone has consistent and predictable pharmacokinetic properties, is unlikely to produce harm, and may be efficacious for treating acute TBI in humans.

Important Papers
  • ProTECT I
  • Pharmacokinetics
  • Review of Progesterone for TBI


 

 

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