Sunovion Pharmaceuticals announced Monday plans to initiate enrollment for a Phase IV trial of the company's antiepileptic drug Aptiom (eslicarbazepine acetate) that will include the use of Empatica's experimental Embrace watch "to detect and record partial-onset seizures subjectively identified by patients or caregivers." Sunovion said "this is the first time that a wearable seizure detection device has been incorporated into the trial design of an anti-epileptic drug for partial-onset seizures."
Antony Loebel, Sunovion's executive vice president, remarked 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." Loebel added we "continue to look for opportunities for Sunovion to leverage advances in digital health."
Sunovion noted that the study is "designed to obtain data in real-world clinical settings supporting the use of Aptiom as adjunctive therapy for partial-onset seizures." The therapy is approved in the US for partial-onset seizures as monotherapy or adjunctive therapy.
Specifically, the 093-701 study will enroll around 190 adults with partial-onset seizures to evaluate patient outcomes from taking Aptiom, as either first add-on therapy following failure of levetiracetam or lamotrigine as monotherapy or as later add-on for patients with treatment-resistant epilepsy requiring additional treatment options. The study's primary endpoint is the proportion of patients completing 24 weeks of treatment.
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