Table 2.
Behavioral Assessment Outcomes
| Assessment | Baseline (screen) | Visit 7 | Visit 8 | Visit 9a |
|---|---|---|---|---|
| CY-BOCS mean total scores ± SD | 22.10 ± 8.02 | 10.05 ± 8.53 | 8.52 ± 9.70 | 5.75 ± 8.53 |
| Percentage changeb | −54.52% | −61.45% | −71.01% | |
| Mean changeb | −12.05 | −13.58 | −14.08 | |
| CY-BOCS p valuesc | <0.0001 | 0.0002 | <0.0001 | |
| CGI-S mean scores ± SD | 4.67 ± 0.86 | 3.29 ± 1.35 | 2.62 ± 1.13 | 2.37 ± 1.30 |
| Percentage changeb | −29.55% | −43.90% | −46.23% | |
| Mean changeb | −1.38 | −2.05 | −2.04 | |
| CGI-S p valuesc | 0.0002 | <0.0001 | <0.0001 | |
| YGTSS mean scores ± SD | 36.81 ± 26.67 | 16.90 ± 19.16 | 12.29 ± 14.27 | 22.87 ± 26.46 |
| Percentage changeb | −54.09% | −66.61% | −44.70% | |
| Mean changeb | −19.91 | −24.52 | −18.50 | |
| YGTSS p valuesc | 0.0003 | 0.0005 | 0.0058 |
a
Subset of patients (n = 12) that participated in a late follow-up visit 29–46 weeks after Visit 8/final infusion and 55–72 weeks after baseline (screen). Percentage change and mean change were only calculated for the subset of participating patients.
b
Percentage and mean change calculated from baseline (screen).
c
p-Values <0.05 were considered statistically significant.
CGI, Clinical Global Impressions of Severity; CY-BOCS, Children's Yale-Brown Obsessive Compulsive Scale; SD, standard deviation; YGTSS, Yale Global Tic Severity Scale.