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 status epilepticus comprising administering to a human patient diagnosed with status epilepticus an effective amount of ganaxolone,
wherein the effective amount of ganaxolone is administered by a combination of a first intravenous dose and a second dose continuous infusion, and
wherein the effective amount provides a consistent ganaxolone plasma concentration of about 500 ng/ml and provides improvement of at least one symptom of the human patient for at least 8 hours after administration.
2. The method of claim 1 , wherein the first dose is an intravenous injection.
3. The method of claim 1 , wherein the first dose is an intravenous infusion.
4. The method of claim 1 , wherein the first dose is characterized by an immediate release profile and wherein the second dose is characterized by and extended release profile.
5. The method of claim 1 , wherein the administration of the first and second doses occurs within 2 hours.
6. The method of claim 1 , wherein the administration of the first and second doses occurs within 30 minutes.
7. The method of claim 1 , wherein the method provides improvement of at least one symptom the human patient for more than 12 hours after administration.
8. The method of claim 1 , wherein the method provides improvement of at least one symptom the human patient for more than 24 hours after administration.
9. The method of claim 1 , wherein the method provides improvement of at least one symptom the human patient for 8 hours to 24 hours after administration.
10. The method of claim 1 , wherein the first dose comprises about 1 mg to about 30 mg ganaxolone.
11. The method of claim 1 , wherein the first dose comprises about 30 mg ganaxolone.
12. The method of claim 1 , wherein the total amount of ganaxolone administered to the human patient in a 24-hour period is 1 mg to 2500 mg.
13. The method of claim 1 , wherein the total amount of ganaxolone administered to the human patient in a 24-hour period is less than about 1500 mg.
14. The method of claim 1 , wherein the total amount of ganaxolone administered to the human patient in a 24-hour period is less than about 1000 mg.
15. A method of treating status epilepticus comprising administering to a human patient diagnosed with status epilepticus an effective amount of ganaxolone,
wherein the effective amount of ganaxolone is administered by a combination of a first intravenous injection and a second dose continuous infusion, and
wherein the effective amount provides a consistent ganaxolone plasma concentration of at least about 500 ng hr/ml and provides improvement of at least one symptom of the human patient for 8 hours to 12 hours after administration.
16. The method of claim 15 , wherein the first dose is characterized by an immediate release profile and wherein the second dose is characterized by and extended release profile.
17. The method of claim 15 , wherein the administration of the first and second doses occurs within 2 hours.
18. The method of claim 15 , wherein the administration of the first and second doses occurs within 30 minutes.
19. A method of treating status epilepticus comprising administering to a human patient diagnosed with status epilepticus a pharmaceutical composition comprising ganaxolone or a pharmaceutically acceptable salt thereof wherein the pharmaceutical composition is administered intravenously to provide about 500 mg to 1000 mg/day ganaxolone and improves at least one symptom for more than 12 hours after administration of the pharmaceutical composition to the patient.
20. The method of claim 19 wherein the composition provides improvement of next day functioning of the patient after administration for more than about 8 hours.
21. The method of claim 19 wherein administration of the composition provides a plasma concentration of about 500 ng/ml for more than about 8 hours.