Ganaxolone for use in treating tuberous sclerosis complex
The disclosure to methods for treating tuberous sclerosis complex or tuberous sclerosis complex-related epilepsy, comprising administering to a subject in need thereof a therapeutically effective amount of a pharmaceutically acceptable pregnenolone neurosteroid, such as ganaxolone, to reduce one or more symptoms of tuberous sclerosis complex or tuberous sclerosis complex-related epilepsy.
1. A method for treating tuberous sclerosis-related epilepsy comprising administering to a subject in need thereof a therapeutically effective amount of ganaxolone.
2. The method of claim 1 , wherein the therapeutic effectively amount is administered orally three times per day.
3. The method of claim 1 , wherein ganaxolone is administered as an oral suspension.
4. The method of claim 1 , wherein ganaxolone is administered as an oral capsule.
5. The method of claim 1 , wherein ganaxolone is administered as a tablet.
6. The method of claim 1 , wherein the therapeutically effective amount is an amount sufficient to produce a ganaxolone plasma concentration of at least about 100 ng/ml for at least about 70% or more per day.
7. The method of claim 1 , wherein the therapeutically effective amount is no more than about 1800 mg per day.
8. The method of claim 7 , wherein the therapeutically effective amount is about 600 mg three times per day.
9. The method of claim 1 , wherein the therapeutically effective amount is no more than about 1500 mg per day.
10. The method of claim 9 , wherein the therapeutically effective amount is about 500 mg three times per day.
11. The method of claim 1 , wherein the therapeutically effective amount is no more than about 63 mg/kg per day.
12. The method of claim 11 , wherein the therapeutically effective amount is about 21 mg/kg three times per day.
13. A method for treating tuberous sclerosis-related epilepsy comprising administering to a subject in need thereof a therapeutically effective amount of ganaxolone that is sufficient to produce a ganaxolone plasma concentration of at least about 100 ng/ml over a period of at least about 70% of a day.
14. The method of claim 13 , wherein the subject is administered ganaxolone three times per day.
15. The method of claim 13 , wherein ganaxolone is administered orally.
16. The method of claim 15 , wherein ganaxolone is administered as an oral suspension.
17. The method of claim 15 , wherein ganaxolone is administered as an oral capsule.
18. The method of claim 17 , wherein ganaxolone is administered as a tablet.
19. The method of claim 13 , wherein ganaxolone is administered as an intravenous infusion.
20. The method of claim 13 , wherein the therapeutically effective amount is no more than about 1800 mg per day.
21. The method of claim 20 , wherein the therapeutically effective amount is about 600 mg three times per day.
22. The method of claim 13 , wherein the therapeutically effective amount is no more than about 1500 mg per day.
23. The method of claim 22 , wherein the therapeutically effective amount is about 500 mg three times per day.
24. The method of claim 13 , wherein the therapeutically effective amount is about 63 mg/kg per day.
25. The method of claim 24 , wherein the therapeutically effective amount is about 21 mg/kg three times per day.