Tolerability and Efficacy of Adjunctive Brivaracetam in Japanese and Chinese Patients With Focal Seizures: Phase 3, Open-Label Extension Trial
Abstract number :
3.286
Submission category :
4. Clinical Epilepsy / 4C. Clinical Treatments
Year :
2025
Submission ID :
69
Source :
www.aesnet.org
Presentation date :
12/8/2025 12:00:00 AM
Published date :
Authors :
Presenting Author: Ayataka Fujimoto, MD – Seirei Hamamatsu General Hospital, Shizuoka, Japan
Bing Qin, MD – The First Affiliated Hospital of Jinan University, Guangdong, China
Juliane Koch, MD – UCB, Monheim am Rhein, Germany
Brian Moseley, MD – UCB
Tomonobu Sano, MS – UCB, Tokyo, Japan
Tadaharu Soma, . – UCB, Tokyo, Japan
Weiwei Sun, M.Med – UCB, Shanghai, China
Dong Zhou, MD – West China Hospital of Sichuan University, Sichuan, China
Yushi Inoue, MD – National Epilepsy Center, National Hospital Organization Shizuoka Institute of Epilepsy and Neurological Disorders, Shizuoka, Japan
Rationale: This trial evaluated long-term safety, tolerability, and maintenance of efficacy of adjunctive brivaracetam (BRV) in Japanese and Chinese patients aged ≥ 16 years with focal seizures.
Methods: EP0085 (NCT03250377) was an open-label, long-term follow-up trial of adjunctive BRV 50–200 mg/day in Japanese and Chinese patients. The primary safety outcome was the incidence of treatment-emergent adverse events (TEAEs). Efficacy outcomes included median percentage reduction in focal seizure frequency/28 days from baseline (BL) to the evaluation period, 50% responder rate (≥50% reduction in focal seizure frequency from BL), seizure freedom (from focal seizures and all epileptic seizures [focal, generalized, unclassified]) during the evaluation period, and the proportion of patients continuously seizure-free from focal seizures and all seizure types for ≥ 6 and ≥ 12 months during the evaluation period (in those exposed to BRV for ≥ 6 and ≥ 12 months, respectively). For patients who rolled over into EP0085, BL was the BL period of the core trial (EP0083/NCT03083665 or N01358/NCT01261325). For direct enrollers, the BL period for seizure outcomes was the 8 weeks before first BRV administration. For all other outcomes, the BL period was trial days on or after the EP0085 screening visit and before the start of the evaluation period in EP0085.
Results: 207 patients enrolled (Japan: 132 [63.8%]; China: 75 [36.2%]); of these, 135 (65.2%) completed the trial, and 72 (34.8%) discontinued. Mean age was 36.7 (SD 14.1) years, and 107 (51.7%) patients were female. The mean (SD) epilepsy duration was 17.16 (13.10) years (n=206). The total duration of BRV exposure was 558.1 patient-years. The mean duration of BRV exposure was 984.7 days (SD 633.9 days; median 710.0 days; range 5–2630 days), with a median modal dose of 200.0 mg/day (range 25.0–200.0 mg/day). TEAEs were reported by 194 (93.7%) patients, drug-related TEAEs by 74 (35.7%), serious TEAEs by 40 (19.3%), and discontinuations due to TEAEs by 10 (4.8%) (Table). Most TEAEs were mild or moderate in intensity, and no deaths were reported. Median focal seizure frequency per 28 days decreased from 7.59 (IQR 4.39, 20.00) during BL to 4.17 (IQR 1.61, 10.46) during the evaluation period. The median percentage reduction in focal seizure frequency/28 days from BL to the evaluation period was 48.2%, and the 50% responder rate was 49.3%. The proportion of patients free from focal seizures and from all seizure types during the entire evaluation period was 5.8% (12 patients) each. In patients exposed to BRV for ≥ 6 months, 19.6% (37/189) were continuously seizure-free from focal seizures and from all seizure types for ≥ 6 months. In patients exposed to BRV for ≥ 12 months, 13.3% (23/173) were continuously seizure-free from focal seizures and from all seizure types for ≥ 12 months.
Conclusions: Long-term adjunctive BRV 50–200 mg/day was well-tolerated and efficacious in Japanese and Chinese patients with focal seizures. No new safety signals were observed.
Funding: UCB-sponsored
Clinical Epilepsy