Sunovion Pharmaceuticals has announced plans to initiate enrollment for a Phase 4 clinical study (Study 093-701) of Aptiom (eslicarbazepine acetate).
The clinical study will include the use of the Embrace watch by Empatica, an investigational wearable device with unique proprietary technology that will be used to detect and record partial-onset seizures subjectively identified by patients or caregivers.
This is the first time that a wearable seizure detection device has been incorporated into the trial design of an anti-epileptic drug (AED) for partial-onset seizures such as APTIOM.
This study is designed to obtain data in real-world clinical settings supporting the use of APTIOM as adjunctive therapy for partial-onset seizures. APTIOM is approved in the U.S. for partial-onset seizures as monotherapy or adjunctive therapy.
“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,” said Antony Loebel, M.D., Executive Vice President and Chief Medical Officer, Sunovion.
“We look forward to sharing the results of this study and continue to look for opportunities for Sunovion to leverage advances in digital health.”
Study 093-701 is a multicenter, open-label, non-randomized Phase 4 trial of APTIOM with two treatment groups, which 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 to AEDs for participants who have previously been treated with another add-on therapy.
The first treatment group will receive APTIOM as first add-on therapy following failure of monotherapy with either lamotrigine or levetiracetam. The second treatment group will receive APTIOM as later add-on therapy for patients with treatment-resistant epilepsy requiring additional therapeutic options.
The primary endpoint is the proportion of patients completing 24 weeks of treatment. Impact on seizure frequency (both subjective and objective), safety, mood and quality of life measures will also be evaluated during the study.