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EndeavorRx

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Monthly starting September, 2021

Clinically proven. Kid-approved.

EndeavorRx has been evaluated in over 600 children with ADHD across 5 clinical studies.¹

Key findings

In our initial clinical trial, patients aged 8-12 played for ~25 minutes per day, 5 days per week for 4 weeks — and a more recent trial demonstrated that a second month of treatment can lead to increased benefits.

68% of parents reported improvement in ADHD-related impairments after two months of treatment.²

1 in 3 children no longer had an attention deficit on at least one measure of attention³

73% of children said they could more easily pay attention after one month of treatment⁴

¹Kollins et al, Lancet Digital Health, 2020. Kollins et al, npj digital medicine, 2021. Proof of concept study: Davis et al, PLOS One, 2018. Pilot studies: Anguera et al., PLOS One, 2017. Yerys et al., J Autism Dev Disord, 2019

²Kollins et al, npj digital medicine, 2021.

³Kollins et al, Lancet Digital Health, 2020

⁴Kollins et al, npj digital medicine, 2021. Data taken from a “Yes-No” Exit Survey.

A closer look at the data

In the STARS-ADHD* pivotal trial, EndeavorRx achieved the primary endpoint, with a mean change in the TOVA® API** (Attention Performance Index) of 0.93, significant compared to a digital control (p=0.006)*

In the STARS-Adjunct open-label study, 206 children aged 8-14 years with ADHD were studied in 2 cohorts: 1) children treated with ADHD stimulant medication (on stimulants, n=130) & 2) children not treated with any ADHD medication (no stimulants, n=76)

Mean change in objective measurement of attention (TOVA API)

*STARS-ADHD 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 (indicating impaired attention function) conducted at 20 sites in the USA. 348 subjects were randomly assigned to receive EndeavorRx (AKL-T01) (n=180) or digital control (n=168) for approximately 25 minutes per day, 5 days per week, for 4 weeks.

**The TOVA® – Test of Variables of Attention – is an FDA-cleared objective, computerized continuous performance test measuring attention and inhibitory control, and can aid in the diagnosis and treatment evaluation of ADHD. The TOVA® API (Attention Performance Index) (also known as TOVA® ACS: Attention Composite Score) is a composite measure that captures attentional functioning at a broad scale, including aspects of sustained and selective attention.

A meaningful impact

In the STARS-Adjunct open-label study, 206 children aged 8-14 years with ADHD were studied in 2 cohorts: 1) children treated with ADHD stimulant medication (on stimulants, n=130) & 2) children not treated with any ADHD medication (no stimulants, n=76)

Both groups were instructed to play EndeavorRx for approximately 25 minutes per day, 5 days per week, over two 4-week treatment periods, separated by a 4-week treatment pause.

After the first 4-week treatment, IRS* overall severity score was significantly improved for both the On Stimulants (-0.7, p<0.001) and No Stimulants (-0.5, p<0.001) cohorts compared to baseline. ADHD-RS** (Total, Inattentive and Hyperactive subscales) and CGI-I were also significantly improved for both cohorts compared to baseline at day 28 and further improved with an additional treatment month (baseline to after the second 4-week treatment).

Treatment with EndeavorRx demonstrated consistent improvements in ADHD symptoms (as measured by ADHD-RS) across our 5 clinical studies, with responder rates (based on a threshold of clinically meaningful change) ranging from 23-36% for one month of treatment to 45% after two months of treatment.

Of 538 participants using EndeavorRx in clinical trials, 50 participants (9.3%) experienced treatment-related adverse events, most commonly frustration (6.1%), headache (1.3%), dizziness (0.6%), emotional reaction (0.4%), nausea (0.4%), and aggression (0.2%). All adverse events were generally transient and there were no serious adverse events reported.

* The IRS: Impairment Rating Scale measures parent-reported ADHD-related impairment across domains such as social functioning, academic progress, and self-esteem, including an overall impairment.

** ADHD-Rating Scale (ADHD-RS), is a ADHD symptoms rating scale. It consists of 18 questions corresponding directly to the DSM symptom criteria for ADHD and offers subscales for the assessment of inattention/hyperactivity-impulsivity.

Interested in the research?

You can take a closer look at our clinical research findings by visiting our publications page.

View publications

Safety Indications

View and download our safety overviews to determine if EndeavorRx is right for your patients.

How To Prescribe

Learn how to identify potential patients + issue prescriptions through our partner pharmacy.

Learn how to prescribe

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EndeavorRx:

Indications, Safety and Cautions

Indications:
EndeavorRx is a digital therapeutic 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, Test 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.

Safety:
Of 538 participants using EndeavorRx, 50 participants (9.3%) experienced treatment-related adverse events (probable, likely), and three participants experienced treatment-related adverse events with the digital control, in studies where a control was used. EndeavorRx associated adverse events included frustration (6.1%), headache (1.3%), dizziness (0.6%), emotional reaction (0.4%), nausea (0.4%), and aggression (0.2%). There were no serious adverse events. All adverse events were generally transient. Only 3 events led to device discontinuation, and no subject reported lasting or irreversible effects after discontinuation.

Cautions:
Rx only: Federal law restricts this device to sale by or on the order of a physician. EndeavorRx should only be used by the patient for whom the prescription was written. For medical questions, please contact your child’s healthcare provider. If you are experiencing a medical emergency, please dial 911. EndeavorRx is not intended to be used as a stand-alone therapeutic and is not a substitution for your child’s medication.

If your child experiences frustration, emotional reaction, dizziness, nausea, headache, eye-strain, or joint pain while playing EndeavorRx pause the treatment. If the problem persists contact your child’s healthcare provider. If your child experiences a seizure stop the treatment and contact your child’s healthcare provider.

EndeavorRx may not be appropriate for patients with photo-sensitive epilepsy, color blindness, or physical limitations that restrict use of a mobile device; parents should consult with their child’s healthcare provider.

Please follow all of your mobile device manufacturer’s instructions for the safe operation of your mobile device. For example, this may include appropriate volume settings, proper battery charging, not operating the device if damaged, and proper device disposal. Contact your mobile device manufacturer for any questions or concerns that pertain to your device.