| |
Placebo-ganaxolone
|
Ganaxolone-placebo
| |
|---|
|
Variable
|
N
|
Mean
|
SE
|
N
|
Mean
|
SE
|
p value
|
|---|
|
Age at visit 1
|
29
|
11.3
|
0.6
|
30
|
10.6
|
0.6
|
0.40
|
|
FSIQ standard score
|
23
|
54.3
|
4.5
|
26
|
48.4
|
2.3
|
0.24
|
| |
N
|
%
| |
N
|
%
| | |
|
Gender
|
|
Male
|
23
|
79.3
| |
27
|
90.0
| |
0.25
|
|
Female
|
6
|
20.7
| |
3
|
10.0
| | |
|
Race
| | | | | | |
|
Asian
|
2
|
6.9
| |
2
|
6.7
| |
0.23
|
|
Black or African American
|
0
|
0.0
| |
4
|
13.3
| | |
|
White
|
24
|
82.8
| |
22
|
73.3
| |
|
More than one race
|
3
|
10.3
| |
2
|
6.7
| |
|
Ethnicity
|
|
Hispanic or Latino
|
5
|
17.2
| |
5
|
16.7
| |
0.58
|
|
Not Hispanic or Latino
|
23
|
79.3
| |
25
|
83.3
| | |
|
Unknown/not reported
|
1
|
3.4
| |
0
|
0.0
| |
|
Concomitant medication
|
|
No
|
2
|
6.9
| |
2
|
6.9
| |
1.00
|
|
Yes
|
27
|
93.1
| |
27
|
93.1
| | |
|
Concomitant medication detailsa
|
|
Aripiprazole
|
4
|
13.8
| |
5
|
17.2
| |
0.72
|
|
Antioxidants
|
2
|
6.9
| |
1
|
3.4
| |
0.55
|
|
Minocycline (Dynacin/Minocin)
|
10
|
34.5
| |
8
|
27.6
| |
0.57
|
|
Ritalin/Concerta/Methylin/Metadate/Methylphenidate
|
3
|
10.3
| |
4
|
13.8
| |
0.69
|
|
Valproic acid (Depakote/Depakene/Epilim/Stavzor)
|
2
|
6.9
| |
3
|
10.3
| |
0.64
|
|
Sertraline (Zoloft)
|
7
|
24.1
| |
8
|
27.6
| |
0.76
|
|
Other medication
|
26
|
89.7
| |
23
|
79.3
| |
0.28
|
- Demographics of intention-to-treat population. There were no statistically significant differences between patients randomized to placebo-ganaxolone and ganaxolone-placebo treatment sequences
-
aConcomitant medication is based on 58 patients, 1 patient is completely missing concomitant medication information
-
SE standard error
