Methods for the treatment of a traumatic central nervous system injury via a tapered administration protocol

Abstract

The present invention provides methods for the treatment or the prevention of neuronal damage in the CNS. Specifically, the methods of the invention provide for the administration of a therapeutically effective amount of a progestin or progestin metabolite following a traumatic or ischemic injury to the CNS such that, prior to termination of administration of the progestin or progestin metabolite the administration is tapered to avoid withdrawal. The drug taper employed can involve a linear taper, an exponential taper, progressively dividing administered doses by 50%, or can be determined based on the treating physician's assessment of the patient's response to therapy. The tapered administration methods of the present invention may be used in combination with any therapeutic protocol or regimen for the administration of a therapeutically effective amount of a progestin or progestin metabolite to treat a traumatic or ischemic CNS injury.

1 . A method of treating a traumatic central nervous system injury, said method comprising administering a therapeutically effective amount of progesterone to a subject in need thereof, wherein prior to termination of administration of progesterone said administration comprises a tapered administration dosing regimen. 
   
   
       2 . The method of  claim 1 , wherein said traumatic central nervous system injury is a traumatic brain injury. 
   
   
       3 . The method of  claim 2 , wherein said traumatic brain injury results from a blunt force contusion. 
   
   
       4 . The method of  claim 1 , wherein said tapered administration dosing regimen comprises progressively dividing administered doses of progesterone by 50%. 
   
   
       5 . The method of  claim 1 , wherein said tapered administration dosing regimen comprises a linear taper. 
   
   
       6 . The method of  claim 5 , wherein said linear taper is a 10% linear taper. 
   
   
       7 . The method of  claim 1 , wherein said tapered administration dosing regimen comprises an exponential taper. 
   
   
       8 . The method of  claim 1 , wherein said tapered administration dosing regimen is used in combination with administration of progesterone at least once a day. 
   
   
       9 . The method of  claim 1 , wherein said therapeutically effective amount of progesterone administered to said subject prior to the tapered administration dosing regime comprises a constant progesterone dosing regimen. 
   
   
       10 . The method of  claim 1 , wherein said therapeutically effective amount of progesterone administered to said subject prior to the tapered administration dosing regime comprises a two-level progesterone dosing regimen.