IP Library Granted Patent US 8,455,468
Granted Patent B2
US 8,455,468 · App. 13/045,180 · Granted Jun 4, 2013

Methods for the treatment of a traumatic central nervous system injury

Inventors: Stuart W. Hoffman (Atlanta, GA); Arthur L. Kellermann (Atlanta, GA); Donald G Stein (Atlanta, GA); David W. Wright (Atlanta, GA); Douglas W. Lowery-North (Atlanta, GA)
Assignee: Emory University
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Quick Facts
Patent No.
US 8,455,468
App. No.
13/045,180
Granted
Jun 4, 2013
Kind
B2
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.

Claims (17)

1. A method of treating a traumatic central nervous system injury in a human subject, comprising administering to said subject an amount of progesterone or synthetic progestin effective to achieve a serum level of progesterone or synthetic progestin of about 100 ng/ml to about 1600 ng/ml.

2. The method of claim 1 , comprising parenterally administering said progesterone or synthetic progestin.

3. The method of claim 1 , comprising administering said progesterone or synthetic progestin by intravenous infusion.

4. The method of claim 1 , wherein progesterone is administered.

5. The method of claim 1 , wherein synthetic progestin is administered.

6. The method of claim 1 , wherein said amount is effective to achieve a serum level of progesterone or synthetic progestin of about 100 ng/ml to about 1000 ng/ml.

7. The method of claim 1 , wherein said amount is effective to achieve a serum level of progesterone or synthetic progestin of about 200 ng/ml to about 450 ng/ml.

8. The method of claim 1 , 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.

9. The method of claim 1 , wherein said progesterone or synthetic progestin is administered at a rate of about 0.1 mg/kg/hr to about 7 mg/kg/hr, based on the subject's body weight.

10. The method of claim 1 , wherein said progesterone or synthetic progestin is administered at a rate of about 0.5 mg/kg/hr, based on the subject's body weight.

11. The method of claim 1 , wherein said progesterone or synthetic progestin is administered at a rate of about 12 mg/kg/day, based on the subject's body weight.

12. The method of claim 1 , wherein said progesterone or synthetic progestin is administered within 24 hours of the central nervous system injury.

13. The method of claim 1 , wherein said progesterone or synthetic progestin is administered within 8 hours of the central nervous system injury.

14. The method of claim 1 , wherein said progesterone or synthetic progestin is administered within 4 hours of the central nervous system injury.

15. A method of reducing or preventing neurodegeneration following a traumatic central nervous system injury in a human subject, comprising administering to said subject an effective amount of progesterone or synthetic progestin.

16. A method of effecting neuroprotection in a human subject in need thereof, comprising administering to said subject an effective amount of progesterone or synthetic progestin.

17. A method of treating a traumatic central nervous system injury in a human subject, comprising administrating to said subject an amount of progesterone or synthetic progestin effective to achieve a serum level of progesterone of synthetic progestin of about 100 ng/ml to about 2000 ng/ml.

Assignments (2)
CONFIRMATORY LICENSE Recorded Oct 19, 2015
From: EMORY UNIVERSITY
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 036897/0380 →
CONFIRMATORY LICENSE Recorded Jul 10, 2013
From: EMORY UNIVERSITY
To: NATIONAL INSTITUTES OF HEALTH (NIH), U.S. DEPT. OF HEALTH AND HUMAN SERVICES (DHHS), U.S. GOVERNMENT
Reel/Frame 030775/0951 →
Continuity (6)
Continuation 12117217 · May 8, 2008
Continuation 11527816 · Sep 27, 2006
Continuation In Part PCTUS2006010797 · Mar 24, 2006
Provisional Application 60664728 · Mar 24, 2005
Provisional Application 60729663 · Oct 24, 2005
Related Publication 20110224181A1 · Sep 15, 2011