Table 1. Demographics and Baseline Characteristics—ITT Population.
| Demographics and Baseline Characteristics | Placebo | SPN-812 | Total | |||||
| 400-mg/day | 600-mg/day | |||||||
| n | 96 | 99 | 97 | 292 | ||||
| Age, years | ||||||||
| Mean (SD) | 13.8 (1.53) | 14.0 (1.74) | 13.7 (1.52) | 13.8 (1.60) | ||||
| Median (min, max) | 14.0 (12, 17) | 14.0 (12, 17) | 13.0 (12, 17) | 14.0 (12, 17) | ||||
| Age group, n (%) | ||||||||
| 12–14 years | 63 (65.6) | 61 (61.6) | 72 (74.2) | 196 (67.1) | ||||
| 15–17 years | 33 (34.4) | 38 (38.4) | 25 (25.8) | 96 (32.9) | ||||
| Gender, n (%) | ||||||||
| Male | 61 (63.5) | 66 (66.7) | 71 (73.2) | 198 (67.8) | ||||
| Female | 35 (36.5) | 33 (33.3) | 26 (26.8) | 94 (32.2) | ||||
| Ethnicity, n (%) | ||||||||
| Not Hispanic and not Latino | 63 (65.6) | 65 (65.7) | 66 (68.0) | 194 (66.4) | ||||
| Hispanic or Latino | 32 (33.3) | 34 (34.3) | 31 (32.0) | 97 (33.2) | ||||
| Not allowed to ask as per local regulations | 1 (1.0) | 0 | 0 | 1 (0.3) | ||||
| Race, n (%) | ||||||||
| White | 64 (66.7) | 63 (63.6) | 66 (68.0) | 193 (66.1) | ||||
| Black or African American | 25 (26.0) | 33 (33.3) | 27 (27.8) | 85 (29.1) | ||||
| Multiple | 6 (6.3) | 3 (3.0) | 2 (2.1) | 11 (3.8) | ||||
| American Indian or Alaska Native | 1 (1.0) | 0 | 1 (1.0) | 2 (0.7) | ||||
| Native Hawaiian or other Pacific Islander | 0 | 0 | 1 (1.0) | 1 (0.3) | ||||
| Weight (kg), mean (SD) | 56.39 (12.897) | 57.19 (11.883) | 55.67 (13.253) | 56.42 (12.657) | ||||
|
Body mass index
(kg/m2), mean (SD) |
21.07 (3.582) | 21.14 (3.512) | 20.99 (3.310) | 21.07 (3.458) | ||||
| ADHD-RS-5, mean (SD) | ||||||||
| Total score | 38.8 (8.06) | 41.2 (7.80) | 39.8 (8.34) | 39.9 (8.10) | ||||
| Inattention | 22.4 (3.59) | 22.5 (3.70) | 22.3 (3.82) | 22.4 (3.69) | ||||
| Hyperactivity/Impulsivity | 16.4 (6.36) | 18.7 (5.59) | 17.5 (6.49) | 17.6 (6.21) | ||||
| CGI-S, mean (SD) | 4.5 (0.66) | 4.8 (0.69) | 4.6 (0.69) | ND | ||||
ADHD-RS-5, ADHD Rating Scale-5; CGI-S, Clinical Global Impression-Severity of Illness; ITT, intent-to-treat; ND, not determined; SD, standard deviation.