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 - 5 . (canceled)
6 . A method of treating CDKL5 deficiency disorder comprising administering to a patient in need thereof a pharmaceutical composition comprising ganaxolone or a pharmaceutically acceptable salt thereof wherein the patient is administered up to 1,800 mg of ganaxolone per day wherein the composition provides reduction in the frequency of seizures.
7 . The method of claim 6 , wherein the patient is administered ganaxolone two times daily.
8 . The method of claim 6 , wherein the patient is administered ganaxolone three times daily.
9 . The method of claim 6 , wherein the pharmaceutical composition is an oral capsule.
10 . The method of claim 6 , wherein the pharmaceutical composition is an oral suspension.
11 . The method of claim 6 , wherein the pharmaceutical composition comprises 200 mg ganaxolone.
12 . The method of claim 6 , wherein the pharmaceutical composition comprises 400 mg ganaxolone.
13 . The method of claim 6 , wherein the pharmaceutical composition comprises 450 mg ganaxolone.
14 . The method of claim 6 , wherein the pharmaceutical composition comprises 600 mg ganaxolone.
15 . The method of claim 6 , wherein the pharmaceutical composition comprises 900 mg ganaxolone.
16 . The method of claim 6 , wherein the pharmaceutical composition comprises 1800 mg ganaxolone.
17 . The method of claim 6 , wherein the patient is administered oral capsules comprising 200-600 mg ganaxolone twice daily.
18 . The method of claim 6 , wherein the composition provides a Cmax less than 300 ng/ml.
19 . The method of claim 6 , wherein the composition provides a Cmax less than 200 ng/ml.
20 . The method of claim 6 , wherein the composition provides a Cmax less than 100 ng/ml.
21 . The method of claim 6 , wherein the composition provides a Cmax between about 100 ng/ml and 200 ng/ml.
22 . The method of claim 6 , wherein the composition provides a Cmax between about 200 ng/ml and 300 ng/ml.
23 . The method of claim 6 , wherein the composition provides a dissolution of at least about 80% within the first 20 minutes of administration to the patient in need thereof.
24 . The method of claim 6 , wherein the average reduction in seizure frequency is about 40%.
25 . The method of claim 6 , wherein the average reduction in seizure frequency is about 40 to about 60%.
26 . The method of claim 6 , wherein the average reduction in seizure frequency is about 40% and the composition provides a Cmax less than 200 ng/ml.
27 . The method of claim 6 , wherein the average reduction in seizure frequency is about 40% and the composition provides a Cmax between about 100 ng/ml and 200 ng/ml.
28 . The method of claim 6 , wherein the average reduction in seizure frequency is about 40% to about 60% and the composition provides a Cmax between about 100 ng/ml and 200 ng/ml.
29 . A method of treating CDKL5 deficiency disorder comprising administering to a patient in need thereof three times daily a pharmaceutical composition comprising ganaxolone or a pharmaceutically acceptable salt thereof wherein the patient is administered up to 1,800 mg of ganaxolone per day wherein the composition provides reduction in the frequency of seizures.
30 . The method of claim 29 , wherein the pharmaceutical composition is an oral capsule.
31 . The method of claim 29 , wherein the pharmaceutical composition is an oral suspension.
32 . The method of claim 29 , wherein the pharmaceutical composition comprises 200 mg ganaxolone.
33 . The method of claim 29 , wherein the pharmaceutical composition comprises 400 mg ganaxolone.
34 . The method of claim 29 , wherein the pharmaceutical composition comprises 450 mg ganaxolone.
35 . The method of claim 29 , wherein the pharmaceutical composition comprises 600 mg ganaxolone.
36 . The method of claim 29 , wherein the pharmaceutical composition comprises 900 mg ganaxolone.
37 . The method of claim 29 , wherein the pharmaceutical composition comprises 1800 mg ganaxolone.
38 . The method of claim 29 , wherein the patient is administered oral capsules comprising 200-600 mg ganaxolone twice daily.
39 . The method of claim 29 , wherein the composition provides a Cmax less than 300 ng/ml.
40 . The method of claim 29 , wherein the composition provides a Cmax less than 200 ng/ml.
41 . The method of claim 29 , wherein the composition provides a Cmax less than 100 ng/ml.
42 . The method of claim 29 , wherein the composition provides a Cmax between about 100 ng/ml and 200 ng/ml.
43 . The method of claim 29 , wherein the composition provides a Cmax between about 200 ng/ml and 300 ng/ml.
44 . The method of claim 29 , wherein the composition provides a dissolution of at least about 80% within the first 20 minutes of administration to the patient in need thereof.
45 . The method of claim 29 , wherein the average reduction in seizure frequency is about 40%.
46 . The method of claim 29 , wherein the average reduction in seizure frequency is about 40% to about 60%.
47 . The method of claim 29 , wherein the average reduction in seizure frequency is about 40% and the composition provides a Cmax less than 200 ng/ml.
48 . The method of claim 29 , wherein the average reduction in seizure frequency is about 40% and the composition provides a Cmax between about 100 ng/ml and 200 ng/ml.
49 . The method of claim 29 , wherein the average reduction in seizure frequency is about 40% to about 60% and the composition provides a Cmax between about 100 ng/ml and 200 ng/ml.