Table 1.
Baseline Characteristics of the Modified Intent-to-Treat Population
| Characteristic | Placebo |
LDX 30 mg |
LDX 50 mg |
LDX 70 mg |
|
|---|---|---|---|---|---|
| (n = 19) | (n = 19) | (n = 18) | (n = 20) | p value | |
| Male gender, n (%) | 16 (84.2) | 16 (84.2) | 13 (72.2) | 18 (90.0) | 0.5576a |
| Age, years; mean (SD) | 9.9 (2.7) | 10.1 (3.1) | 10.0 (2.9) | 10.1 (2.5) | 0.9963b |
| Height, cm; mean (SD) | 138.2 (15.5) | 139.2 (17.4) | 135.0 (13.5) | 138.9 (13.7) | 0.8183b |
| Bodyweight, kg; mean (SD) | 34.9 (12.3) | 38.5 (15.9) | 33.1 (11.2) | 35.8 (11.7) | 0.6416b |
| Previous medical conditions; n (% pts) | 8 (42.1) | 2 (10.5) | 5 (27.8) | 3 (15.0) | 0.1091a |
| Concurrent medical conditions; n (% pts) | 14 (73.7) | 14 (73.7) | 12 (66.7) | 17 (85.0) | 0.6216a |
| Previous drug treatment; n (% pts) | 6 (31.6) | 7 (36.8) | 6 (33.3) | 5 (25.0) | 0.9024a |
| ADHD subtype; n (% pts) | 0.1217a | ||||
| Combined | 14 (73.7) | 10 (52.6) | 13 (72.2) | 11 (55.0) | |
| Predominantly inattentive | 3 (15.8) | 9 (47.4) | 5 (27.8) | 9 (45.0) | |
| Predominantly hyperactive/impulsive | 2 (10.5) | 0 (0.0) | 0 (0.0) | 0 (0.0) | |
| ADHD-RS-IV total score <40 at baseline; n (% pts) | 12 (63.2) | 12 (63.2) | 12 (66.7) | 12 (60.0) | 0.9610b |
| ADHD-RS-IV total score ≥40 at baseline; n (% pts) | 7 (36.8) | 7 (36.8) | 6 (33.3) | 8 (40.0) | |
| Baseline ADHD-RS-IV total score; mean (SD) | 37.9 (7.4) | 38.1 (6.7) | 37.1 (6.9) | 37.2 (7.8) |
a
Fisher's exact test.
b
One-way analysis of variance.
ADHD, attention-deficit/hyperactivity disorder; LDX, lisdexamfetamine; m-ITT, modified intent-to-treat; pts, patients; SD, standard deviation.