Methods and compositions for treatment of epileptic disorders
Use of allosteric modulators and/or gaboxadol for the treatment of epileptic disorders in a subject in need thereof.
1. A method of treating Lennox-Gastaut syndrome comprising administering to a patient in need thereof a pharmaceutical composition comprising ganaxolone or a pharmaceutically acceptable salt thereof wherein the pharmaceutical composition is administered as an oral suspension.
2. The method of claim 1 , wherein the pharmaceutical composition provides an in vivo plasma profile having a Cmax less than about 500 ng/ml.
3. The method of claim 1 , wherein the pharmaceutical composition provides an in vivo plasma profile having a AUC of less than about 900 ng hr/ml.
4. The method of claim 1 , wherein the patient is provided improvement of at least one symptom for more than 4 hours after administration of the pharmaceutical composition to the patient.
5. The method of claim 1 , wherein the patient is administered ganaxolone or a pharmaceutically acceptable salt thereof once daily or twice daily or three times daily.
6. The method of claim 1 , wherein the patient is administered ganaxolone or a pharmaceutically acceptable salt thereof in an amount of up to 1,800 mg/day.
7. The method of claim 1 , wherein the pharmaceutical composition comprises 50 mg/ml ganaxolone or a pharmaceutically acceptable salt thereof.
8. The method of claim 1 , wherein the patient is administered 200-600 mg ganaxolone or a pharmaceutically acceptable salt thereof.
9. The method of claim 1 , wherein the pharmaceutical composition provides reduction in the frequency of seizures, the severity of seizures, or a combination thereof.
10. The method of claim 1 , wherein the patient is administered about 150 mg to 1000 mg/day ganaxolone.
11. A method of treating Lennox-Gastaut syndrome comprising administering to a human patient diagnosed with Lennox-Gastaut syndrome a pharmaceutical composition comprising ganaxolone or a pharmaceutically acceptable salt thereof.
12. The method of claim 11 , wherein the pharmaceutical composition provides an in vivo plasma profile having a Cmax less than about 500 ng/ml.
13. The method of claim 11 , wherein the pharmaceutical composition provides an in vivo plasma profile having a Cmax less than about 200 ng/ml.
14. The method of claim 11 , wherein the pharmaceutical composition provides an in vivo plasma profile having a AUC of less than about 900 ng hr/ml.
15. The method of claim 11 , wherein the pharmaceutical composition provides an in vivo plasma profile having a Cmax less than about 500 ng/ml and provides an in vivo plasma profile having a AUC of less than about 900 ng hr/ml.
16. The method of claim 11 , wherein the patient is provided improvement of at least one symptom for more than 4 hours after administration of the pharmaceutical composition to the patient.
17. The method of claim 11 , wherein the patient is provided improvement of at least one symptom for more than 8 hours after administration of the pharmaceutical composition to the patient.
18. The method of claim 11 , wherein the patient is administered ganaxolone or a pharmaceutically acceptable salt thereof once daily.
19. The method of claim 11 , wherein the patient is administered ganaxolone or a pharmaceutically acceptable salt thereof twice daily.
20. The method of claim 11 , wherein the patient is administered ganaxolone or a pharmaceutically acceptable salt thereof three times daily.
21. The method of claim 11 , wherein the patient is administered ganaxolone or a pharmaceutically acceptable salt thereof in an amount of up to 1,800 mg/day.
22. The method of claim 11 , wherein the pharmaceutical composition comprises 50 mg/ml ganaxolone or a pharmaceutically acceptable salt thereof.
23. The method of claim 11 , wherein the patient is administered 600 mg ganaxolone or a pharmaceutically acceptable salt thereof.
24. The method of claim 11 , wherein the patient is administered 50 mg ganaxolone or a pharmaceutically acceptable salt thereof.
25. The method of claim 11 , wherein the patient is administered 100 mg ganaxolone or a pharmaceutically acceptable salt thereof.
26. The method of claim 11 , wherein the patient is administered 200 mg ganaxolone or a pharmaceutically acceptable salt thereof.
27. The method of claim 11 , wherein the patient is administered 300 mg ganaxolone or a pharmaceutically acceptable salt thereof.
28. The method of claim 11 , wherein the patient is administered 400 mg ganaxolone or a pharmaceutically acceptable salt thereof.
29. The method of claim 11 , wherein the patient is administered 500 mg ganaxolone or a pharmaceutically acceptable salt thereof.
30. The method of claim 11 , wherein the patient is administered 200-600 mg ganaxolone or a pharmaceutically acceptable salt thereof.
31. The method of claim 11 , wherein the pharmaceutical composition provides reduction in the frequency of seizures, the severity of seizures, or a combination thereof.
32. The method of claim 11 , wherein the ganaxolone within the patient about 4 hours after administration of the pharmaceutical composition is between about 65% to about 85% of the administered dose.
33. The method of claim 11 , wherein the pharmaceutical composition comprises about 30 mg ganaxolone.
34. The method of claim 11 , wherein the patient is administered about 150 mg to 1000 mg/day ganaxolone.
35. The method of claim 11 , wherein the patient is administered about 500 mg to 1000 mg/day ganaxolone.
36. The method of claim 11 , wherein the patient is administered about 625 mg to 650 mg/day ganaxolone.
37. The method of claim 11 , wherein the patient is administered about 650 mg to 675 mg/day ganaxolone.
38. The method of claim 11 , wherein the patient is administered about 675 mg to 700 mg/day ganaxolone.
39. The method of claim 11 , wherein the patient is administered about 625 mg to 700 mg/day ganaxolone.
40. The method of claim 11 , wherein the patient is administered about 700 mg to 725 mg/day ganaxolone.
41. The method of claim 11 , wherein the patient is administered about 1025 mg to 1050 mg ganaxolone.