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Objective: Our study assessed perampanel monotherapy in patients (aged ≥12 years) with focal‐onset seizures (FOS) with or without focal to bilateral tonic‐clonic seizures (FBTCS) in Japan and South Korea. Methods: Study 342 (NCT03201900; FREEDOM) is a single‐arm, open‐label, Phase III study. Patients initially received perampanel in a 32‐week 4‐mg/d Treatment Phase (6‐week Titration; 26‐week Maintenance Periods). If they experienced a seizure during the 4‐mg/d Maintenance Period, they could be up‐titrated to 8 mg/d across an additional 30‐week Treatment Phase (4‐week Titration; 26‐week Maintenance Periods). Primary endpoint was the seizure‐freedom rate during the Maintenance Period (4 mg/d and last evaluated dose [4 or 8 mg/d]). Secondary endpoints included time to first seizure onset and to withdrawal during Maintenance. Treatment‐emergent adverse events (TEAEs) were monitored. Results: At data cutoff (February 28, 2019), 89 patients with FOS (84 [94.4%] with newly diagnosed epilepsy and 5 [5.6%] with recurrence of epilepsy after a period of remission) had received ≥1 perampanel dose; 16 patients discontinued during the 4‐mg/d Titration Period, meaning 73 patients entered the 4‐mg/d Maintenance Period and were included in the primary analysis set for efficacy. Seizure‐freedom rate in the 26‐week Maintenance Period was 46/73 (63.0%; 95% confidence interval [CI]: 50.9‐74.0) at 4 mg/d and 54/73 (74.0%; 95% CI: 62.4‐83.5) at 4 or 8 mg/d. Cumulative probability of seizure‐onset and withdrawal rates during Maintenance was 30.8% (95% CI: 21.5‐43.0) and 23.7% (95% CI: 15.4‐35.3) at 4 mg/d, and 18.2% (95% CI: 11.0‐29.3) and 23.3% (95% CI: 15.2‐34.8) at 4 or 8 mg/d. Perampanel was generally well tolerated, and the most common TEAE was dizziness. Significance: Perampanel monotherapy (4 to 8 mg/d) was efficacious and consistent with the known safety profile up to 26 weeks in patients (≥12 years) with primarily newly diagnosed FOS with or without FBTCS. [ABSTRACT FROM AUTHOR]

We developed and evaluated a preliminary scintillating fiber-based real-time dose monitoring system (SRDMS) for brachytherapy. The SRDMS consisted of a detector section with 10 scintillating fibers (BCF-12, Saint Gobain Inc., S.A. France) inserted into a long barrel cylinder and a readout system comprising a photo-multiplier tube (PMT H12428-203 MOD, Hamamatsu Photonics, Shizuoka, Japan) and National Instrument Measurement & Automation Explorer (NI MAX, National Instruments, TX, USA). Basic system performance was estimated by measuring the dwell position and time for various patterns of source motion. Signal output response with data sampling, linearity, and reproducibility was also evaluated. In addition, dwell position and time measurement via the SRDMS were compared across three treatment plans, which were applied to a silicone-based human phantom to evaluate the system's response to more complex and realistic situations. The difference between the measured source dwell position and plan was -0.52 ± 0.53 mm. The difference between the measured dwell time and plan was 7 ± 5 ms. For signal output verification, the signal-to-SD ratio was less than 1.5%. The signal output linearity was maintained at -0.43 ± 0.50%, and reproducibility was 1.35 ± 1.44%. In this study, we demonstrated that the SRDMS can accurately detect relative dwell positions and dwell times. In further studies, we plan to verify the accuracy of relative source strength, and update the SRDMS with real-time monitoring. The SRDMS could be used for real-time dose monitoring during brachytherapy. [ABSTRACT FROM AUTHOR]