Table 1.
Participant Demographics and Clinical Characteristics at Baseline (ITT Population).
| Parameter | Placebo (N = 24) | SPN-812 (mg/day) |
|||
|---|---|---|---|---|---|
| 100 (N = 45) | 200 (N = 46) | 300 (N = 47) | 400 (N = 44) | ||
| Age, years, median (range) | 9.0 (6-11) | 8.0 (6-12) | 9.0 (6-12) | 9.0 (6-12) | 9.0 (6-12) |
| Height, cm, median (range) | 134.2 (115-153) | 132.0 (116-169) | 138.8 (115-167) | 135.9 (117-172) | 136.8 (109-162) |
| Weight, kg, median (range) | 28.2 (21-49) | 29.1 (20-64) | 33.3 (21-66) | 33.1 (21-62) | 32.6 (20-59) |
| BMI, kg/m2, median (range) | 16.8 (14-22) | 17.0 (14-23) | 16.7 (13-26) | 17.7 (14-26) | 17.4 (13-24) |
| Sex, n (%) | |||||
| Male | 11 (45.8) | 27 (60.0) | 33 (71.7) | 36 (76.6) | 31 (70.5) |
| Female | 13 (54.2) | 18 (40.0) | 13 (28.3) | 11 (23.4) | 13 (29.5) |
| Race, n (%) | |||||
| White | 17 (70.8) | 22 (48.9) | 26 (56.5) | 24 (51.1) | 28 (63.6) |
| Black or African American | 7 (29.2) | 19 (42.2) | 16 (34.8) | 22 (46.8) | 15 (34.1) |
| American Indian or Alaska Native | 0 | 0 | 1 (2.2) | 1 (2.1) | 0 |
| Asian | 0 | 0 | 2 (4.3) | 0 | 0 |
| Multiple | 0 | 4 (8.9) | 1 (2.2) | 0 | 1 (2.3) |
| ADHD-RS-IV scores, M (SD) | |||||
| Total | 42.4 (7.8) | 42.4 (6.8) | 43.9 (7.5) | 41.3 (7.9) | 40.8 (7.9) |
| Hyperactivity/Impulsivity Subscale | 20.5 (4.4) | 20.3 (5.2) | 21.7 (5.1) | 19.4 (6.0) | 19.7 (4.4) |
| Inattention Subscale | 21.9 (4.7) | 22.1 (3.9) | 22.2 (3.6) | 21.8 (3.8) | 21.0 (4.7) |
| CGI-S Score, M (SD) | 4.7 (0.69) | 4.9 (0.59) | 4.9 (0.64) | 4.8 (0.70) | 4.8 (0.71) |
Note. ITT = intention-to-treat; BMI = body mass index; ADHD-RS-IV = ADHD Rating Scale-IV; M = mean; CGI-S = Clinical Global Impression-Severity Scale.