STARS-ADHD Pivotal Study

Study Design

A randomized, double-blind, parallel-group, 4-week, controlled trial of AKL-T01* in children aged 8-12 years old with ADHD (not taking ADHD medications) and TOVA API baseline scores of ≤ −1.8, conducted at 20 sites in the USA. 348 subjects were randomly assigned to receive AKL-T01 (n=180) or control (n=168) for approximately 25 minutes per day, 5 days per week, for 4 weeks.

Objectives

The primary endpoint was mean change in TOVA API from pre- to post-intervention (baseline to 4 weeks). Secondary endpoints were mean changes in ADHD-RS (Total, Inattentive, Hyperactive), IRS, CGI-I, BRIEF (working memory, inhibit).

Results

The primary endpoint was achieved, mean change from baseline on the TOVA API was 0.93 in the AKL-T01 group versus 0.03 in the control group (p=0.006). The secondary endpoint within-group (baseline to post-treatment) changes were all significantly improved, and several mean changes numerically favored AKL-T01 over control (ADHD-RS Total, ADHD-RS Inattentive, IRS), however there was no statistically meaningful difference in a non-parametric analysis of the 7 secondary parental or clinical rating scales (Adjusted p=0.34 to 1.00). There were two notable responder analyses (56% of parents indicated the treatment improved their child’s attention and 48% were shown to improve their ADHD-related impairment as reported in the IRS).

Safety and Compliance

There were no serious adverse events or discontinuations. Treatment-related adverse events were mild and included frustration (5 [3%] of 180), headache (3 [2%] of 180) and emotional reaction (2 [1%] of 180). Patient compliance was a mean of 83 (83%) of 100 expected sessions played (SD, 29.2 sessions).

*EndeavorOTC was previously known as AKL-T01 during the clinical investigations.