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

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

  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
  1. Demographics of intention-to-treat population. There were no statistically significant differences between patients randomized to placebo-ganaxolone and ganaxolone-placebo treatment sequences
  2. aConcomitant medication is based on 58 patients, 1 patient is completely missing concomitant medication information
  3. SE standard error