Methods for the treatment of a traumatic central nervous system injury
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. A method of treating a traumatic brain injury in a human subject in need thereof, said method comprising administering to said subject at least one cycle of therapy, wherein said cycle of therapy comprises administering a therapeutically effective two-level intravenous dosing regimen of progesterone, said two-level dosing regimen comprising a first time period, wherein a higher hourly infusion dose of progesterone is administered to the subject, followed by a second time period, wherein a lower hourly infusion dose of progesterone is administered to said subject.
2. The method of claim 1 , wherein the first time period comprises an infusion dose of progesterone of about 0.1 mg/kg/hr to about 7 mg/kg/hr.
3. The method of claim 2 , wherein the first time period comprises an infusion dose of progesterone of about 0.5 mg/kg/hr to about 1 mg/kg/hr.
4. The method of claim 3 , wherein the first time period comprises an infusion dose of progesterone of about 0.7 mg/kg/hr.
5. The method of claim 1 , wherein the second time period comprises an infusion dose of progesterone of about 0.05 mg/kg/hr to about 5 mg/kg/hr.
6. The method of claim 5 , wherein the second time period comprises an infusion dose of progesterone of about 0.5 mg/kg/hr to about 1 mg/kg/hr.
7. The method of claim 6 , wherein the second time period comprises an infusion dose of about 0.5 mg/kg/hr.
8. The method of claim 1 , wherein the second time period comprises about a 24 hour to about a 120 hour period.
9. The method of claim 8 , wherein the second time period comprises about a 71 hour period.
10. The method of claim 1 , wherein the first time period comprises an infusion dose of progesterone of about 0.7 mg/kg/hr, the second time period comprises an infusion dose of about 0.5 mg/kg/hr, the first time period comprises about 1 hour, and the second time period comprises about a 71 hour period.
11. The method of claim 1 , wherein the two-level intravenous dosing regimen of progesterone results in a progesterone serum level in said subject of about 100 ng/ml to about 2000 ng/ml.
12. The method of claim 11 , wherein the progesterone serum level is about 100 ng/ml to about 1000 ng/ml.
13. The method of claim 12 , wherein the progesterone serum level is about 200 ng/ml to about 450 ng/ml.
14. The method of claim 12 , wherein the progesterone serum level is about 350 ng/ml to about 450 ng/ml.
15. The method of claim 1 , wherein the two-level intravenous dosing regimen of progesterone results in a progesterone serum level in said subject of less than 450 ng/ml.
16. The method of claim 1 , further comprising a third time period, wherein said third time period comprises a tapered administration of progesterone to the subject.
17. The method of claim 1 , wherein the first and the second time periods are continuous.
18. The method of claim 1 , wherein the first and the second time periods are discontinuous.
19. The method of claim 1 , wherein said first time period comprises a bolus injection.
20. A method for treating a traumatic brain injury in a human subject in need thereof comprising administering to said subject a therapeutically effective amount of progesterone.
21. The method of claim 20 , wherein said progesterone is administered intravenously.
22. The method of claim 21 , wherein said effective amount of progesterone comprises a daily dose of 12 mg/kg of body weight.
23. The method of claim 22 , wherein said daily dose is administered within 24 hours post injury.
24. The method of claim 20 , wherein said progesterone is in a cyclodextrin carrier.
25. The method of claim 21 , further comprising administering to said human subject a subsequent daily dose comprising an effective amount of progesterone, wherein the effective amount of progesterone in the subsequent daily dose is about 12 mg/kg of body weight.
26. The method of claim 21 , said method comprising administering to said subject at least one cycle of therapy, wherein said cycle of therapy comprises administering a therapeutically effective constant intravenous dosing regimen of progesterone.
27. The method of claim 26 , wherein the constant intravenous dosing regimen comprises an infusion dose of progesterone of about 0.1 mg/kg/hr to about 7 mg/kg/hr.
28. The method of claim 27 , wherein the constant intravenous dosing regimen comprises an infusion dose of progesterone of about 0.5 mg/kg/hr to about 1 mg/kg/hr.
29. The method of claim 28 , wherein the constant intravenous dosing regimen comprises an infusion dose of progesterone of about 0.7 mg/kg/hr.
30. The method of claim 26 , wherein the constant intravenous dosing regimen of progesterone results in a progesterone serum level in said subject of about 100 ng/ml to about 2000 ng/ml.
31. The method of claim 30 , wherein the progesterone serum level is about 100 ng/ml to about 1000 ng/ml.
32. The method of claim 31 , wherein the progesterone serum level is about 200 ng/ml to about 450 ng/ml.
33. The method of claim 31 , wherein the progesterone serum level is about 350 ng/ml to about 450 ng/ml.
34. The method of claim 26 , wherein the constant intravenous dosing regimen of progesterone results in a progesterone serum level in said subject of less than 450 ng/ml.