Clinical Trial Uses Wearable Device in Medication Study for Adults with Partial-Onset Seizures

At the American Epilepsy Society 70th Annual Meeting, Sunovion Pharmaceuticals announced that it plans to start enrollment for a Phase 4 clinical study of adults with uncontrolled partial-onset seizures. The study will investigate the use of APTIOM^® (eslicarbazepine acetate) as add-on therapy for partial-onset seizures in adults.

Unique to this study is the use of the Embrace watch to detect and record partial-onset seizures subjectively identified by patients or caregivers. Made by Empatica, the Embrace is a wearable device that monitors physiological stress, arousal, sleep, and physical activity. Separately, it is being studied to determine its long-term effectiveness for detecting and alerting wearers and caregivers to convulsive seizures.

Sunovion’s multicenter, open-label, non-randomized Phase 4 trial of APTIOM will enroll approximately 190 adults with partial-onset seizures. The study will evaluate the outcomes among patients with uncontrolled partial-onset seizures taking APTIOM, as either first add-on therapy to levetiracetam or lamotrigine monotherapy or as later add-on therapy for people with treatment-resistant epilepsy requiring additional therapeutic options. Impact on seizure frequency (both subjective and objective), safety, mood, and quality of life measures will also be evaluated during the study.

“At the Epilepsy Therapy Project of the Epilepsy Foundation, we support novel approaches and nourish partnerships that have the potential of improving the lives of people living with epilepsy," said Daniel Fischer, director of the Epilepsy Therapy Project. "We are encouraged by the recent partnership between Empatica and Sunovion to use the Embrace seizure-tracking device in a phase 4 clinical study of the drug Aptiom. This partnership could lead to more accurate methods for data collection in epilepsy clinical trials and eventually result in better treatments for people with epilepsy.”

The Embrace was the beneficiary of an Epilepsy Foundation Indiegogo crowdfunding campaign in 2014. It was also a People’s Choice Award winner in the 2013 Shark Tank Competition and a Judge’s Choice Award winner in 2015 Shark Tank Competition. Sunovion is an active partner and supporter of the Epilepsy Foundation.