Table 1.
Participant Demographic and Baseline Clinical Characteristics, Safety Analysis Set
| |
Optimized LDX dose |
Total (N = 113) | ||||
|---|---|---|---|---|---|---|
| Characteristic | 5 mg (n = 1) | 10 mg (n = 12) | 15 mg (n = 21) | 20 mg (n = 26) | 30 mg (n = 53) | |
| Antecedent study age (years),a mean ± SD | 5.0 (—) | 4.7 ± 0.47 | 4.6 ± 0.51 | 4.6 ± 0.49 | 4.6 ± 0.49 | 4.6 ± 0.48 |
| Current age (years),b mean ± SD | 5.0 (—) | 4.8 ± 0.39 | 4.6 ± 0.59 | 4.7 ± 0.69 | 4.8 ± 0.67 | 4.8 ± 0.63 |
| Male, n (%) | 1 (100) | 9 (75.0) | 15 (71.4) | 18 (69.2) | 37 (69.8) | 80 (70.8) |
| Race, n (%) | ||||||
| White | 1 (100) | 7 (58.3) | 13 (61.9) | 16 (61.5) | 26 (49.1) | 63 (55.8) |
| Black/African American | 0 | 4 (33.3) | 7 (33.3) | 9 (34.6) | 22 (41.5) | 42 (37.2) |
| American Indian/Alaska native | 0 | 0 | 0 | 0 | 1 (1.9) | 1 (0.9) |
| Multiple | 0 | 1 (8.3) | 0 | 0 | 1 (1.9) | 2 (1.8) |
| Other | 0 | 0 | 1 (4.8) | 1 (3.8) | 3 (5.7) | 5 (4.4) |
| Weight (kg), mean ± SD | 18.2 (—) | 20.8 (1.51) | 20.2 (2.64) | 20.9 (2.46) | 21.3 (4.61) | 20.9 (3.60) |
| BMI (kg/m2),c mean ± SD | 15.0 (—) | 16.3 (0.96) | 16.5 (1.36) | 16.3 (1.44) | 16.6 (2.58) | 16.5 (2.00) |
| ADHD-RS-IV-PS score, mean ± SD | ||||||
| Totald | 52.0 (—) | 44.3 (6.77) | 45.0 (7.47) | 44.1 (6.90) | 43.1 (5.99) | 43.8 (6.54) |
| Inattentiond | 26.0 (—) | 21.8 (4.53) | 21.3 (4.14) | 21.0 (4.90) | 20.0 (3.69) | 20.7 (4.18) |
| Hyperactivity/impulsivityd | 26.0 (—) | 22.4 (2.87) | 23.7 (4.13) | 23.1 (3.76) | 23.1 (3.20) | 23.2 (3.45) |
| ADHD subtype, n (%) | ||||||
| Predominantly inattentive | 0 | 0 | 2 (9.5) | 0 | 0 | 2 (1.8) |
| Predominantly hyperactive/impulsive | 0 | 1 (8.3) | 0 | 0 | 3 (5.7) | 4 (3.5) |
| Combined | 1 (100) | 11 (91.7) | 19 (90.5) | 26 (100) | 49 (92.5) | 106 (93.8) |
| Missing | 0 | 0 | 0 | 0 | 1 (1.9) | 1 (0.9) |
| Peabody Picture Vocabulary Test standard score, mean ± SD | 112.0 (—) | 96.3 ± 11.64 | 101.5 ± 16.41 | 102.3 ± 15.36 | 103.2 ± 16.34 | 102.1 ± 15.59 |
| CGI-S score, mean ± SD | 6.0 (—) | 4.8 ± 0.72 | 5.0 ± 0.77 | 5.2 ± 0.54 | 4.9 ± 0.78 | 5.0 ± 0.73 |
| CGI-S, n (%) | ||||||
| Moderately ill | 0 | 4 (33.3) | 5 (23.8) | 2 (7.7) | 16 (30.2) | 27 (23.9) |
| Markedly ill | 0 | 6 (50.0) | 12 (57.1) | 18 (69.2) | 30 (56.6) | 66 (58.4) |
| Severely ill | 1 (100) | 2 (16.7) | 3 (14.3) | 6 (23.1) | 4 (7.5) | 16 (14.2) |
| Among the most extremely ill | 0 | 0 | 1 (4.8) | 0 | 3 (5.7) | 4 (3.5) |
Baseline was defined as the baseline value from the antecedent study (phase 2 study [NCT02402166]; phase 3 study [NCT03260205]) for antecedent participants or the last observation before the first dose of investigational product for directly enrolled participants.
Age was calculated as the difference between date of birth and date of informed consent for the antecedent study, truncated to years; n = 11 (10 mg); n = 16 (15 mg); n = 17 (20 mg); n = 41 (30 mg); n = 86 (total).
Current age was calculated as the difference between date of birth and date of informed consent for this study (NCT03260205), truncated to years.
BMI was calculated as [weight (kg)/height (m)2].
n = 20 (15 mg) and n = 112 (total).
ADHD, attention-deficit/hyperactivity disorder; ADHD-RS-IV-PS, ADHD Rating Scale-IV Preschool version; BMI, body mass index; CGI-S, Clinical Global Impressions–Severity; LDX, lisdexamfetamine dimesylate; SD, standard deviation.