Table 1.
Demographic and Clinical Characteristics at Baseline (Safety Population)a
| MEM-MD-57A Part 2 (Double-blind) | MEM-MD-67 (Open-label extension) | |||
|---|---|---|---|---|
| Characteristic | Placebo (n = 61) | Mem (n = 60) | Placebo/Mem (n = 50) | Mem/Mem (n = 52) |
| Age, yearsb | 8.9 ± 2.2 | 9.0 ± 2.2 | 9.1 ± 2.3 | 9.1 ± 2.2 |
| Boys, n (%) | 49 (80.3) | 52 (86.7) | 41 (82.0) | 46 (88.5) |
| Race, n (%) | ||||
| White | 49 (80.3) | 50 (83.3) | 42 (84.0) | 44 (84.6) |
| Asian | 6 (9.8) | 5 (8.3) | 4 (8.0) | 5 (9.6) |
| Black | 3 (4.9) | 1 (1.7) | 1 (2.0) | 1 (1.9) |
| Other | 3 (4.9) | 4 (6.7) | 3 (6.0) | 2 (3.8) |
| Weight group distribution, n (%) | ||||
| Group A (≥60 kg) | 4 (6.6) | 5 (8.3) | n/a | n/a |
| Group B (40-59 kg) | 14 (23.0) | 17 (28.3) | n/a | n/a |
| Group C (20-39 kg) | 42 (68.9) | 37 (61.7) | n/a | n/a |
| Group D (<20 kg) | 1 (1.6) | 1 (1.7) | n/a | n/a |
| Education Status, n (%) | ||||
| Public School | 48 (78.7) | 48 (80.0) | n/a | n/a |
| Private School | 5 (8.2) | 5 (8.3) | n/a | n/a |
| Home School | 1 (1.6) | 2 (3.3) | n/a | n/a |
| Other | 6 (9.8%) | 5 (8.3) | n/a | n/a |
| K-BIT2 scoreb | ||||
| IQ composite | 75.7 ± 19.4 | 77.9 ± 23.1 | 75.9 ± 19.8 | 78.2 ± 23.8 |
| Verbal score | 36.4 ± 19.4 | 37.0 ± 16.2 | 35.6 ± 18.2 | 37.4 ± 16.3 |
| Nonverbal score | 32.1 ± 26.1 | 26.3 ± 18.1 | 31.6 ± 25.8 | 25.9 ± 17.8 |
| ADOS Scoreb | ||||
| Communication | 6.3 ± 2.1 | 6.3 ± 2.2 | n/a | n/a |
| Social interaction | 11.0 ± 2.8 | 10.3 ± 2.5 | n/a | n/a |
| Total | 17.3 ± 4.5 | 16.7 ± 4.2 | n/a | n/a |
| SRS, Total Raw Scoreb,c | 100.2 ± 21.4 | 101.3 ± 25.2 | 100.5 ± 19.7 | 102.2 ± 25.5 |
a
The safety population in trials MEM-MD-57A Part 2 and MEM-MD-67 included seven children with autism spectrum disorder who did not have autism.
b
Mean ± standard deviation.
c
MEM-MD-57A Part 2: Autism ITT population (placebo, n = 53, memantine, n = 54); MEM-MD-67: Autism safety population (placebo/memantine, n = 46; memantine/memantine, n = 47).
ADOS, Autism Diagnostic Observation Schedule; IQ, intelligence quotient; K-BIT2, Kaufman Brief Intelligence Test, Version 2; Mem, extended-release memantine; SRS, Social Responsiveness Scale.