Meet the First and Only FDA-cleared Video Game Treatment for Inattention in Children with ADHD
To learn more about this treatment, please join us for a live webinar at one of the available options listed below.
Treating Pediatric ADHD with a Novel Prescription Digital Therapeutic
Thursday, September 30, 6:00PM PT, 7:00PM MT, 8:00PM CT, 9:00PM ET, Raun Melmed, MD
Tuesday, October 26, 6:00PM PT, 7:00PM MT, 8:00PM CT, 9:00PM ET, Raun Melmed, MD
Don't miss out. Register today!
It's time to change the way medicine is designed, delivered and experienced. At Akili, we believe effective medicine for serious illnesses can also be fun and engaging. We're creating a new class of digital medicines for people living with cognitive impairment, delivered through captivating video game experiences.
EndeavorRx: Indications, Cautions and Safety
Indications for Use:
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.
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.
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.
Akili, EndeavorRx, Akili Care, ADHD Insight, and Insight, as well as the logos for each, are trademarks or registered trademarks of Akili Interactive Labs, Inc. Other trademarks are trademarks or registered trademarks of their respective owners.