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) | Â |