Table 3 Secondary Efficacy Endpoints – ADHD RS Change from Baseline to Day 28 or 42 for Efficacy Population in Adolescent (N = 146) and Adult (N = 153) Samples
From: Two single arm trials of AKL-T01, a digital therapeutic for adolescents and adults with ADHD
Parameter | Statistic | Baseline | Day 28 (Adolescent) or 42 (Adult) | Change from baseline |
|---|---|---|---|---|
Adolescent ADHD-RS-5 Inattention subscale | n | 145 | 146 | 145 |
Mean (SD) | 18.91 (5.09) | 15.98 (5.61) | −2.99 (5.38) | |
Median | 20.0 | 16.0 | −3.0 | |
Interquartile range | 16.0, 23.0 | 12.0, 21.0 | −6.0, 0.0 | |
Min, max | 2, 27 | 2, 27 | −20, 10 | |
2-sided 95% CIa | −3.87, −2.10 | |||
P-valueb | <0.0001 | |||
Adolescent ADHD-RS-5 Total score | n | 144 | 146 | 144 |
Mean (SD) | 31.5 (9.17) | 27.0 (9.95) | −4.59 (8.14) | |
Median | 31.0 | 26.0 | −4.5 | |
Interquartile range | 25.5, 38.0 | 21.0, 35.0 | −10.0, 1.0 | |
Min, max | 8, 52 | 3, 51 | −32, 17 | |
2-sided 95% CIa | −5.93, −3.25 | |||
P-valueb | < 0.0001 | |||
Adult ADHD-RS-IV Inattention subscale | n | 153 | 153 | 153 |
Mean (SD) | 21.8 (3.26) | 16.7 (4.98) | −5.1 (4.78) | |
Median | 22.0 | 17.0 | −5.0 | |
Interquartile range | 20.0, 24.0 | 13.0, 20.0 | −8.0, −1.0 | |
Min, max | 12, 27 | 5, 27 | −20, 5 | |
2-sided 95% CIa | −5.86, −4.34 | |||
P-valueb | <0.0001 | |||
Adult ADHD-RS-IV Total score | n | 153 | 153 | 153 |
Mean (SD) | 38.2 (7.41) | 30.0 (9.40) | −8.3 (7.74) | |
Median | 38.0 | 29.0 | −8.0 | |
Interquartile range | 33.0, 43.0 | 24.0, 36.0 | −13.0, −3.0 | |
Min, max | 24, 54 | 9,5 3 | −32, 9 | |
2-sided 95% CIa | −9.51, −7.04 | |||
P-valueb | <0.0001 |
