Sunovion Pharmaceuticals said today that it will soon begin enrollment for a Phase IV study of its anti-epileptic drug Aptiom with Empatica‘s Embrace watch. The Marlborough, Mass.-based company touted its study as the 1st to incorporate a wearable seizure device with an anti-epileptic drug into the design of a clinical trial for partial-onset seizures.
The Embrace watch is an investigational device that will be used in the study to detect and record partial-onset seizures as they are identified by patients or caregivers. Aptiom (eslicarbazepine acetate) is approved in the U.S. as a stand-alone or adjunctive therapy for partial-onset seizures.
The clinical trial is open-label, non-randomized and is slated to enroll 190 adults with partial-onset seizures. The 2 treatment groups will both receive Aptiom, but 1 will be treated with it as a 1st line of defense after a primary therapy fails. The 2nd treatment arm will receive Aptiom as a later add-on therapy for patients with treatment-resistant epilepsy that requires additional therapeutic options. Impact on seizure frequency, which will be measured with the help of the wearable watch, as well as safety, mood and quality of life will be evaluated throughout the study.
“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,” executive VP & chief medical officer Dr. Antony Loebel said in prepared remarks. “We look forward to sharing the results of this study and continue to look for opportunities for Sunovion to leverage advances in digital health.”