Table 1.
Baseline characteristics
| Placebo | Basmisanil | ||
|---|---|---|---|
| 120 mg (80 mg) | 240 mg (160 mg) | ||
| n = 58 | n = 55 | n = 57 | |
| Age (years) | |||
| Mean ± SD | 18.7 ± 5.2 | 18.3 ± 4.9 | 18.7 ± 5.4 |
| Median | 18.0 | 17.0 | 17.0 |
| Minimum to maximum | 12–30 | 12–28 | 12–29 |
| 12–17 years: n (%) | 28 (48%) | 28 (51%) | 29 (51%) |
| 18–30 years: n (%) | 30 (52%) | 27 (49%) | 28 (49%) |
| Sex | |||
| Males: n (%) | 33 (57%) | 32 (58%) | 38 (67%) |
| Females: n (%) | 25 (43%) | 23 (42%) | 19 (33%) |
| Ethnicity | |||
| Hispanic or Latino: n (%) | 11 (19.0%) | 13 (23.6%) | 10 (17.5%) |
| Not Hispanic or Latino: n (%) | 38 (65.5%) | 35 (63.6%) | 39 (68.4%) |
| Unknown: n (%) | 9 (15.5%) | 7 (12.7%) | 8 (14.0%) |
| Race: n (%) | |||
| American Indian or Alaska Native | 1 (1.7%) | 0 | 0 |
| Asian | 1 (1.7%) | 1 (1.8%) | 0 |
| Black or African American | 0 | 2 (3.6%) | 0 |
| Multiple: White/Asian | 2 (3.4%) | 0 | 0 |
| White | 45 (77.6%) | 44 (80.0%) | 49 (86.0%) |
| Unknown | 9 (15.5%) | 8 (14.5%) | 8 (14.0%) |
| Formulationa | |||
| Granules: n (%) | 10 (17%) | 10 (18%) | 12 (21%) |
| Tablets: n (%) | 48 (83%) | 45 (82%) | 45 (79%) |
| CGI-severity | |||
| Mean ± SD | 3.7 ± 1.0 | 3.8 ± 0.9 | 3.9 ± 0.9 |
| Median | 4.0 | 4.0 | 4.0 |
| Minimum to maximum | 1–5 | 1–5 | 1–6 |
| ≤ 3: n (%) | 18 (31%) | 16 (31%) | 12 (22%) |
| > 3: n (%) | 40 (69%) | 36 (69%) | 43 (78%) |
| CELF-4 (word classes 1): mean ± SD | |||
| Receptive | 15.2 ± 4.3 | 15.2 ± 3.9 | 14.7 ± 4.9 |
| Expressive | 9.7 ± 5.4 | 9.6 ± 4.2 | 9.8 ± 5.1 |
| CELF-4 (word classes 2): mean ± SD | |||
| Receptive | 3.5 ± 4.1 | 2.98 ± 3.4 | 2.8 ± 3.2 |
| Expressive | 1.8 ± 2.3 | 1.4 ± 1.7 | 1.5 ± 1.9 |
| Anxiety/mood (ADAMS): mean ± SD | |||
| Depressed mood | 2.5 ± 2.9 | 2.1 ± 2.0 | 2.5 ± 3.1 |
| Anxiety | 2.6 ± 2.3 | 2.5 ± 2.5 | 2.6 ± 2.9 |
| Manic/hyperactive | 3.2 ± 2.4 | 4.0 ± 3.1 | 3.1 ± 2.8 |
| Obsessive/compulsive | 1.9 ± 2.0 | 1.9 ± 1.8 | 1.7 ± 1.8 |
| Social avoidance | 3.8 ± 3.9 | 4.3 ± 3.7 | 3.8 ± 3.9 |
| IQb | |||
| Mean ± SD | 52.8 ± 13.6 | 55.2 ± 14.6 | 55.6 ± 13.9 |
| Median | 49 | 53 | 57 |
| Minimum to maximum | 32–93 | 32–93 | 32–80 |
Abbreviations: ADAMS Anxiety, Depression and Mood Abnormalities, CELF Clinical Evaluation of Language Fundamentals, CGI Clinical Global Impression, SD standard deviation
aA granule formulation was available for individuals with difficulties swallowing tablets (assessed in comparative bioavailability study WP28978 [NCT02194244])
bIQ assessed by Leiter International Performance Scale-revised: a non-verbal intelligence test