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Table 2 Demographics. Child study

From: Arbaclofen in fragile X syndrome: results of phase 3 trials

Group/characteristic

Placebo (N = 45)

Arbaclofen

Total (N = 169)

5 mg BID (N = 41)

10 mg BID (N = 41)

10 mg TID (N = 42)

Mean age (SD)

8.0 (2.20)

7.5 (1.86)

7.5 (1.81)

8.1 (2.02)

7.8 (1.99)

Gender (males)

38 (84.4%)

35 (83.3%)

35 (83.3%)

36 (83.7%)

144 (83.7%)

Race/ethnicity

 White non-hispanic

38 (84.4%)

29 (69.0%)

32 (76.2%)

36 (83.7%)

135 (78.5%)

 White hispanic

2 (4.4%)

2 (4.8%)

4 (9.5%)

3 (7.0%)

11 (6.4%)

 American Indian or Alaska Native

0

1 (2.4%)

0

0

1 (0.6%)

 African American

2 (4.4%)

2 (4.8%)

1 (2.4%)

1 (2.3%)

6 (3.5%)

 Asian

1 (2.2%)

3 (7.1%)

0

1 (2.3%)

5 (2.9%)

 Other

2 (4.4%)

5 (11.9%)

5 (11.9%)

2 (4.7%)

14 (8.1%)

Concomitant medications

 Any

33 (73.3%)

34 (81.0%)

28 (66.7%)

32 (74.4%)

127 (73.8%)

 Antipsychotics

12 (26.7%)

9 (21.4%)

4 (9.6%)

6 (14.0%)

31 (18.0%)

 None

12 (26.7%)

8 (19.0%)

14 (33.3%)

11 (25.6%)

45 (26.2%)

DSM-IV diagnosis of ASD

34 (75.6%)

32 (76.2%)

35 (83.3%)

35 (81.4%)

136 (79.1%)

Mean ABC-CFX Social Avoidance score (SD)

6.9 (3.49)

6.9 (2.84)

6.9 (3.03)

6.4 (2.92)

 
  1. BID twice daily, TID three times daily, SD standard deviation, ASD autism spectrum disorder, ABC-C FX Aberrant Behavior Checklist refactored for FXS