Positive topline results shown in clinical trial of adolescent ADHD treatment

A digital medicine company has revealed positive topline results of an expansionist study evaluating the efficacy and safety of a novel therapeutic device to treat adolescents with ADHD.

According to a release from Akili Inc., the study achieved its primary efficacy outcome by demonstrating statistically significant improvement in attentional functioning after 4 weeks of treatment. EndeavorRx treatment was also generally well-tolerated, with no serious device-related adverse events reported.

The multicenter, open-label study, called STARS-ADHD-Adolescents, enrolled 162 adolescents aged 13 to 17 years with inattentive or combined-type ADHD. In the study, AKL-T01 demonstrated a statistically significant improvement in the Test of Variables of Attention-Attention Comparison Score (ACS) of sustained and selective attention from baseline after 1 month of treatment, the release said.

Per the release, the change from baseline on the TOVA ACS was nearly three times as large as the changes seen in STARS-ADHD, a large randomized controlled trial of children aged 8 to 12 years with ADHD, that served as the basis for EndeavorRx’s FDA authorization in that age group.

In the STARS-ADHD-Adolescents study, 66% of trial participants met the prespecified definition of clinical response on the TOVA ACS — a computerized test cleared by the FDA to assess attention deficits and evaluate the effects of interventions in ADHD — and 24.7% moved into the non-clinical, or normative, range.

“The results of this study extend the already substantial evidence base to support the efficacy of EndeavorRx for improving attentional functioning in patients with ADHD, and most importantly show the ability of this safe treatment to help teenagers, who have been significantly impacted by the current mental health crisis,” Akili chief medical officer Scott Kollins, PhD, said in the release.

Akili stated in the release that it plans to present full data from the study at a future medical meeting, and the company will file for EndeavorRx label expansion with the FDA later this year.