FDA Cleared First Video Game to Treat Children with ADHD

Endeavor: Digital Therapeutic (the First Prescription Non-Drug Treatment) to Improve Attention in Children with ADHD Delivered Through an Action Video Game

The US Food and Drug Administration (FDA) cleared the first digital prescription attention treatment device (EndeavorRx™: prescription-only game-based device) to improve attention in pediatric patients ages 8 to 12 years old  with attention deficit hyperactivity disorder (ADHD) delivered through a video game.

Indication

EndeavorRx is indicated to improve attention function as measured by computer-based testing in children ages 8-12 years old with primarily inattentive or combined-type ADHD, who have a demonstrated attention issue. Patients who engage with EndeavorRx demonstrate improvements in a digitally assessed measure Tests of Variables of Attention (TOVA) of sustained and selective attention and may not display benefits in typical behavioral symptoms, such as hyperactivity. EndeavorRx should be considered for use as part of a therapeutic program that may include: clinician-directed therapy, medication, and/or educational programs, which further address symptoms of the disorder.

Regulatory Pathway

The device (EndeavorRx) was cleared through the De Novo premarket review pathway because there was no legally marketed device (predicate device) to demonstrate substantial equivalence.  The De Novo is a regulatory pathway for low- to moderate-risk devices of a new type, creating a new regulatory classification.  The said new regulatory classification means that subsequent devices of the same type with the same intended use may go through the FDA’s 510(k) premarket notification process, whereby devices can obtain marketing clearance by demonstrating substantial equivalence to a predicate device (EndeavorRx).

The EndeavorRx is manufactured by Akili Interactive.

Clinical Trials

The FDA’s clearance for EndeavorRx was based on multiple (5) clinical studies (listed below) in more than 600 children diagnosed with ADHD, including a prospective, randomized, controlled study published* in The Lancet Digital Health journal, which showed EndeavorRx improved objective measures of attention in children with ADHD. After four weeks of EndeavorRx treatment, one-third of children no longer had a measurable attention deficit on at least one measure of objective attention.  Further, about half of parents saw a clinically meaningful change in their child’s day-to-day impairments after one month of treatment with EndeavorRx; this increased to 68% after a second month of treatment. Improvements in ADHD impairments following a month of treatment with EndeavorRx were maintained for up to a month.

The Endeavor treatment (AKL-T01) has been studied in over 600 children with ADHD across 5 clinical studies. 3 studies in ADHD (STARS-ADHD, STARS-Adjunct and ADHD-POC) and 2 pilot studies in ADHD with different comorbidities (Sensory Processing Disorder and Autism Spectrum Disorder).

  1. STARS-ADHD Pivotal Study: 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.
  2. STARS-Adjunct Study: a multicenter, 12-week, open-label study of Endeavor (AKL-T01) in 206 children aged 8-14 years with ADHD, consisting of 2 cohorts: 1) Subjects currently treated with ADHD medication (On Stimulants, n=130) and 2) Subjects not on any ADHD medication (No Stimulants, n=76). Subjects required an IRS score of ≥3 at baseline and both cohorts received AKL-T01 for approximately 25 minutes per day, 5 days per week, over two 4 week treatment periods, separated by a 4-week treatment pause. There was no digital control in this study.
  3. ADHD Proof of Concept Study: A 4-week, open-label study of EndeavorRx (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 ADHDRS 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.
  4. Sensory Processing Disorder (SPD): a pilot study of EndeavorRx (AKL-T01) in children ages 8-12 with SPD only (n=13), SPD+ADHD (n=20) and Healthy Controls (n=24). There was improvement in objective attention measures comparable to STARS-ADHD and the SPD+ADHD group showed a decrease in parent-reported ADHD-inattentive symptoms (-4.5 / SD=4.7).
  5. Autism Spectrum Disorder (ASD): a randomized, double-blind, controlled study of EndeavorRx (AKL-T01) in 19 children ages 9-13 years old with ASD and comorbid ADHD, 11 randomized to AKL-T01 and 8 to digital control. AKL-T01 group improved in TOVA API (1.86 / SD=3.66) while the Control group worsened (-0.82 / SD=3.4). AKL-T01 group improved in ADHD symptoms (ADHD-RS-Total, -6.72 / SD=5.6). Both groups had high compliance with their intervention. There
    was one non-serious AE (decreased frustration tolerance) in the AKL-T01 group.

Improvements in attention function were measured by the Test of Variables of Attention (TOVA), academic performance measures, and other assessment tools.  No serious adverse events were reported. The most common adverse events observed with EndeavorRx are:

  • frustration
  • headache
  • dizziness
  • emotional reaction
  • aggression

*: access link in PDF at https://www.thelancet.com/action/showPdf?pii=S2589-7500%2820%2930017-0

“We’re proud to make history today with FDA’s decision”, said Eddie Martucci, Ph.D., chief executive officer of Akili. “With EndeavorRx, we’re using technology to help treat a condition in an entirely new way as we directly target neurological function through medicine that feels like entertainment. Families are looking for new ways to help their children with ADHD. With today’s decision by FDA, we’re excited to offer families a first-of-its-kind non-drug treatment option and take an important first step toward our goal to help all people living with cognitive issues.”

“The EndeavorRx device offers a non-drug option for improving symptoms associated with ADHD in children and is an important example of the growing field of digital therapy and digital therapeutics,” said Jeffrey Shuren, M.D., J.D., director of the FDA’s Center for Devices and Radiological Health. “The FDA is committed to providing regulatory pathways that enable patients timely access to safe and effective innovative digital therapeutics.”

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Last Updated: 2020-06-25

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