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Phase III Clinical Trial for using Progesterone in TBI treatment

Progerstone for TBI Tested in Phase III

The hormone progesterone will be used soon by seventeen medical centers all over the nation for the treatment of Traumatic Brain Injury patients. The treatment will be enrolling an estimated 1,140 TBI patients for 3 to 6 years and is a random Phase III clinical trail of the progesterone hormone. The National Institute of Health has given a grant for the funding

of this research to Emory University. Dr. David Wright of Emory University School of Medicine leads the research trial and the leading center for the trial is Grady Memorial Hospital in Atlanta.

There is a natural presence of the hormone progesterone in a small quantity in the human brain. Progesterone receptors are loaded in the tissues of the human brain. It has been found that the normal development of neurons and a protective shield to brain tissues that are damaged is dependant on progesterone. The researchers at Emory had conducted a three year trial of progesterone in 100 TBI patients and the conclusion that they found was administering the progesterone hormone in these patients was safe enough and reduced the danger of disability and death. This was the first clinical trial and was named as ProTECT I which stands for Progesterone for Traumatic Brain Injury – Experimental Clinical Treatment. Accordingly the name given to the latest trial is ProTECT III.

A head injury hits a random person in the United States every 15 seconds. Statistics show that 2 million people are affected by head injury annually resulting in 80,000 disabilities and 50,000 deaths. Dr. Wright said that not a single treatment for head injury has been passed to be perfect in the last 30 years. He also said that the previous trails of the progesterone treatment were successful and in the current trial the research hopes the conclusion that a simultaneous treatment of progesterone and the standard medical treatment for head injuries work much better to reduce the damage to the brain due to TBI than the standard treatment alone. Two professors from Emory, Michael Frankel, MD, and Jeffrey Salomone, MD, will act as the principal investigators. The University of Michigan coordinates a network called as Neurological Emergencies Treatment Trial (NETT) through which the trial will take place and Medical University of South Carolina will be doing the analysis of the data collected.

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Progesterone for Traumatic Brain Injury Tested in Phase III Clinical Trial

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