ADHD Proof of Concept Study

Study Design

A 4-week, open-label study of AKL-T01* in children aged 8-12 years old, comparing 40 children with ADHD to 40 neurotypical children (healthy controls). The ADHD group were required to have an in-clinic diagnosis of ADHD, not be taking ADHD medications and have an ADHD-RS total score of  ≥24 at baseline (healthy controls were required to have an ADHD-RS ≤13). The study was conducted at 3 sites in the US.

Treatment

Subjects were instructed to complete approximately 25 minutes of AKL-T01 per day, 5 days per week for 4 weeks. 

Objectives: To explore whether subjects demonstrated improvements in attention function, as measured by TOVA and other measures. 

Results

Improvements were observed on TOVA API for the ADHD group (mean change=-1.43, p=0.033, d=0.35). There was no significant change for the healthy control group (mean change= -0.39, p=0.30, d=017).

Safety and Compliance

There were no treatment-related adverse events. 84% of treatment sessions were completed.

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