STARS-ADHD Adult Study

The STARS-ADHD Adult study used to generate data to support AKL-T01* enrolled 221 adults, 18 years and older, with ADHD for a six-week treatment period.

Study Design

An open label single arm 6 week trial of AKL-T01 in adults. 18 years and older, with ADHD, primarily inattentive or combined-type ADHD (either on or off ADHD medication) with a TOVA ACS baseline score ≤ -1.8, conducted at 14 sites in the USA.  The 221 participants were asked to engage with the treatment for approximately 25 minutes per day, 5 days per week, for 6 weeks.

Objectives

The primary endpoint was mean change in TOVA ACS from pre- to post-intervention (baseline to 6 weeks). Secondary endpoints were mean changes in ADHD-RS (Total score and Inattentive subscore). Exploratory endpoints were AAQoL total score, AAQoL Life Productivity Subscore, CAARS-S:S and TOVA results other than the API.

Results

The primary endpoint was achieved; mean change from baseline on the TOVA ACS was 6.46 (p=0001). Adults using AKL-T01 also showed significant improvement in their ADHD symptoms, as measured by the clinician-administered Attention Deficit Hyperactivity Disorder Rating Scale-5 (ADHD-RS). Following treatment, participants in the study showed significant improvement on both the inattention subscale and total score of the ADHD-RS (p<0.0001 for both). A prespecified responder analysis also showed that 32.7% of all participants in the study demonstrated at least a 30% reduction in total scores on the ADHD-RS. Nearly three-quarters (72.5%) of adults reported at least some improvement in their quality of life as measured by the validated Adult ADHD Quality of Life Scale (AAQoL), and nearly 50 percent (45.8%) of adults met a prespecified threshold for clinically meaningful improvement.

Safety and Compliance

Overall, 11 (5%) of the participants in the trial reported a treatment-emergent adverse device event, most commonly nausea (1.8%) and headache (1.4%). There were no serious adverse device events.

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