Table 3

Efficacy analyses in subjects with ABC-LSW ≥8 at baseline.

STX209 (least squares mean ± SEM),
n = 27
Placebo (least squares mean ± SEM),
n = 27
P
BaselineEnd of treatmentBaselineEnd of treatment
ABC-LSW16.2 ± 1.2112.4 ± 1.4316.0 ± 1.3015.9 ± 1.450.07
ABC—Social Avoidance6.8 ± 0.604.6 ± 0.545.9 ± 0.626.4 ± 0.530.04
Vineland-Socialization raw score*80.1 ± 8.1099.6 ± 3.3883.1 ± 8.6587.8 ± 3.190.03
CGI-I2.5 ± 0.243.6 ± 0.250.02
CGI-S5.4 ± 0.224.4 ± 0.215.3 ± 0.225.2 ± 0.220.009
Blinded treatment preference (clinician)16/20 (80%)4/20 (20%)0.01
Blinded treatment preference (parent)16/20 (80%)4/20 (20%)0.01
Responders10/21 (47.6%)2/23 (8.7%)0.04

*Vineland-Socialization raw score only had data at the end of treatment and baseline; there were no data in the middle of period.

†This table reports on a subgroup of 27 subjects; only 20 subjects had data on these particular variables. Thus, seven subjects had missing data on these variables.

‡Responders were defined by a rating of “very much” or “much improved” on the CGI-I and improvement of at least 25% on the ABC-LSW. Not all 27 subjects had ABC-LSW raw score and CGI-I at the end of each treatment.