Professor of Neurology University of California San Francisco San Francisco, California
Rationale: Wearable technology has demonstrated the potential to detect seizures, and cell phone applications (apps) are often used to record seizures. Eslicarbazepine acetate (ESL) is a once-daily, oral antiseizure drug (ASD) for focal seizures. Here, we report the concordance in daily seizure frequency between a traditional paper seizure diary versus an electronic seizure diary or a wearable seizure detection watch, in a study of ESL in a real-world clinical setting. Methods: Seizure frequency was analyzed during a Phase IV, prospective, open-label, non-randomized study of adjunctive ESL in patients aged ≥ 18 years with focal seizures, conducted in the USA and Canada (NCT03116828). The study included two arms: Arm 1 – ESL taken as a first adjunctive therapy with levetiracetam or lamotrigine monotherapy; and Arm 2 – ESL taken as a later adjunctive therapy, following current or prior use of adjunctive therapy. The trial included screening (one to two weeks), titration (two weeks), maintenance (24 weeks), and ESL taper/safety follow-up (four weeks) periods. Electronic methods of seizure data capture were the Mate phone app and the Embrace seizure detection watch, both from Empatica Inc. Mean proportion of concordance (MPC) in daily seizure frequency was calculated as the number of days in which daily seizure frequency was concordant between the paper seizure diary and the Mate app or Embrace watch, divided by the total number of days that seizure frequency was documented via the paper seizure diary, during the 24-week maintenance period. Results: The analysis population included 41 patients in Arm 1 and 55 patients in Arm 2. Overall, 1,635 seizures were recorded in paper seizure diaries compared with 1,401 in the Mate app, and the Embrace watch detected 4,376 seizures; focal impaired awareness was the most common seizure type. The MPC (95% CI) in daily seizure frequency between the paper seizure diary and Mate app was 93.0% (88.6%, 97.5%) in Arm 1 and 88.2% (82.6%, 93.7%) in Arm 2. The MPC was ≥ 89.5% (83.5%, 95.4%) for all seizure types (focal aware, focal impaired awareness, focal to bilateral tonic-clonic, and other), in both arms. In comparison, the MPC (95% CI) in daily seizure frequency was lower between the paper seizure diary and Embrace watch: 62.1% (51.0%, 73.3%) in Arm 1 and 61.2% (52.4%, 69.9%) in Arm 2. Conclusions: In this real-world, open-label study of ESL in patients with focal seizures, stronger concordance in daily seizure frequency was observed between paper and electronic seizure diaries compared with a paper diary and seizure detection watch. Funding: Please list any funding that was received in support of this abstract.: Study funded by Sunovion Pharmaceuticals Inc.
