Sunovion taps Empatica for Phase 4 drug trial -- and two other digital health projects targeting epilepsy

By Jonah Comstock
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Marlborough, Massachusetts-based pharma company Sunovion will use the Empatica Embrace, a wearable device for seizure detection, in a phase 4 clinical study of Aptiom, a drug meant to reduce seizures in people with epilepsy.

“We believe that incorporating digital health technologies into traditional treatment paradigms has the potential to inform and enhance best practices and further empower people living with serious medical conditions and their families,” Dr. Antony Loebel, executive vice president and chief medical officer at Sunovion, said in a statement. “We look forward to sharing the results of this study and continue to look for opportunities for Sunovion to leverage advances in digital health.”

The Empatica Embrace is the latest version of a wearable developed by Rosalind Picard, an MIT professor who formerly co-founded a company called Affectiva. Back in late 2011, Affectiva launched an emotional arousal wearable called the Q-sensor based on Picard's research with children with epilepsy at Boston Children's Hospital. In April 2013, though, as MobiHealthNews reported at the time, Affectiva discontinued the Q-sensor and refocused the company on emotional analysis for advertising focus groups. Picard left the company and joined up with Empatica, a company founded by Italians Matteo Lai and Simone Tognetti focused on creating a similar wearable. Empatica was crowdfunding the Embrace in January 2015.

The use of wearables and digital health to treat or manage epilepsy seems to be having a moment. For instance, Poole Hospital in Dorset England is working with Microsoft to detect patient seizures using the Microsoft Band.

"Using the Microsoft Band, in conjunction with software on the patient’s mobile phone, the Epilepsy Care Alliance have harnessed machine learning powered by Microsoft Azure to track patients’ daily activities and detect when they are experiencing a seizure," Microsoft writes in a news post. "The app on their mobile device can be used to alert their next of kin and to send details to their NHS clinical team so that their care can be adjusted accordingly. The Alliance are rolling this program out across Dorset and hope to help around 2,000 patients in the County to manage their condition more effectively and help them to lead fuller lives."

A program at the University of Illinois at Chicago, meanwhile, is using digital health technology to help people with epilepsy self-manage their condition. It's called PAUSE, or "Personalized Internet Assisted Underserved Self-management for Epilepsy".

“The PAUSE program is based on the coordinated care model,” Dr. Dilip Pandey, associate professor of neurology and rehabilitation in the UIC College of Medicine and a lead investigator on the PAUSE project, said in a statement. “The health care provider identifies information the patient can use to build self-management skills, and also asks each patient what they want to learn about their epilepsy, whether it’s medication management, avoiding seizure triggers, issues around driving – whatever they want to know about. Then, we program the PAUSE tablet to include the corresponding educational modules, containing information provided by the Epilepsy Foundation website. This allows us to create a personalized self-management education program for each patient.”