Methods for the treatment of a traumatic central nervous system injury

Abstract

Methods of treating a subject with a traumatic central nervous system injury, more particularly, a traumatic brain injury, are provided. The methods comprise a therapy comprising a constant or a two-level dosing regime of progesterone. In one method, a subject in need thereof is administered at least one cycle of therapy, wherein the cycle of therapy comprises administering a therapeutically effective two-level intravenous dosing regime of progesterone. The two-level dosing regime comprises a first time period, wherein a higher hourly dose of progesterone is administered to the subject, followed by a second time period, wherein a lower hourly dose of progesterone is administered to the subject.

1 .- 14 . (canceled) 
     
     
         15 . A method of providing neuroprotection to a human subject in need thereof, comprising administering to the subject a therapeutically effective amount of a pharmaceutical composition comprising progesterone or a synthetic progestin. 
     
     
         16 . The method of  claim 15 , wherein the pharmaceutical composition is administered by a route selected from the group consisting of oral, vaginal, rectal, topical, nasal, ophthalmic, and parenteral. 
     
     
         17 . The method of  claim 15 , wherein the pharmaceutical composition is administered by a route selected from the group consisting of systemic, intraperitoneal, intravenous (IV), intramuscular (IM), subcutaneous (SC), transdermal, buccal, and intracerebroventricular. 
     
     
         18 . The method of  claim 15 , wherein the pharmaceutical composition is in a form selected from the group consisting of a solid, a particulant, a powder, a solution, a suspension, and an emulsion. 
     
     
         19 . The method of  claim 15 , wherein the pharmaceutical composition comprises progesterone or a pharmaceutically acceptable salt thereof. 
     
     
         20 . The method of  claim 15 , wherein the pharmaceutical composition comprises a synthetic progestin or a pharmaceutically acceptable salt thereof. 
     
     
         21 . The method of  claim 15 , wherein the amount is effective to achieve a serum level of progesterone or synthetic progestin of about 100 ng/ml to about 2000 ng/ml. 
     
     
         22 . The method of  claim 15 , wherein the amount is effective to achieve a serum level of progesterone or synthetic progestin of about 200 ng/ml to about 450 ng/ml. 
     
     
         23 . The method of  claim 15 , wherein said amount is effective to achieve a serum level of progesterone or synthetic progestin of about 350 ng/ml to about 450 ng/ml.