A randomized double-blind, placebo-controlled trial of ganaxolone in children and adolescents with fragile X syndrome

Table 1 Demographic and clinical characteristics of 59 participants, randomly assigned to placebo-ganaxolone and ganaxolone-placebo

	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 details^a
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

ISSN: 1866-1955