Long-Term Safety, Tolerability, and Efficacy of Brivaracetam in Patients With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
Abstract number :
2.334
Submission category :
7. Anti-seizure Medications / 7B. Clinical Trials
Year :
2025
Submission ID :
760
Source :
www.aesnet.org
Presentation date :
12/7/2025 12:00:00 AM
Published date :
Authors :
Presenting Author: Madalina Leanca, MD – Centrul National Clinic de Recuperare Neuropsihomotorie Copii - Doctor Nicolae Robanescu, Bucuresti, Romania
Sophia Bakhtadze, MD, PhD – Tbilisi State Medical University, Givi Zhvania Pediatric University Clinic, Tbilisi, Georgia
Christoph Reichel, PhD – UCB, Monheim am Rhein, Germany
Fiona Brock, MSc – UCB, Slough, United Kingdom
Carrie McClung, MS – UCB, Morrisville, NC, United States
Brian Moseley, MD – UCB
Rationale: Childhood absence epilepsy (CAE) and juvenile absence epilepsy (JAE) have limited treatment options. Long-term safety, tolerability, and efficacy of brivaracetam (BRV) were assessed in patients with CAE or JAE aged 2-26 yrs who had participated in the ongoing core Phase 3 trial N01269 (NCT04666610).
Methods: Phase 3, open-label, multicenter, single-arm, long-term follow-up (LTFU) trial (EP0132/NCT05109234; 3/30/2022-3/18/2025) of BRV (tablet/oral solution administered twice daily in equal doses [50-200 mg/day; or equivalent dose of 1-4 mg/kg/day for patients weighing < 50 kg]). The primary endpoints were treatment-emergent adverse events (TEAEs) and TEAEs leading to BRV discontinuation. The secondary endpoints were absence seizure freedom (ASF) during 1-h electroencephalogram (EEG) at trial visits, and ASF per patient daily seizure diary records by 3‑month time intervals and over the evaluation period (entry visit [day 1]-final visit [month 24]/early discontinuation visit for those who completed trial/prematurely discontinued). Most patients completed the trial before month 24 and transitioned to a new ongoing BRV LTFU trial (EP0224/NCT06315322) or post-trial access program.
Results: Of 84 patients who received ≥ 1 BRV dose (Safety Set), 64 (76.2%) had CAE (57.8% female; mean [SD] age: 9.56 [2.49] yrs) and 20 (23.8%) had JAE (55.0% female; mean [SD] age: 13.93 [1.64] yrs). Patients had been living with absence epilepsy for a mean (SD) of 1.59 (2.31) yrs (CAE: 1.72 [2.47] yrs; JAE: 1.19 [1.64] yrs). 27 (32.1%) patients had concomitant antiseizure medications (ASMs; ≥ 1 day in common with BRV) (CAE: 21 [32.8%]; JAE: 6 [30.0%]). 64 (76.2%) patients completed the trial (CAE: 50 [78.1%]; JAE: 14 [70.0%]); the most common primary reasons for discontinuation (≥ 5% of patients) were consent withdrawn by parent/legal guardian (8.3%) and lack of efficacy (6.0%). During the evaluation period, patients were on BRV for a median (range) of 16.18 (0.4, 31.0) months (CAE [n=64]: 14.60 [0.4, 31.0] months; JAE [n=20]: 20.60 [6.4, 29.0] months). 38 (45.2%) patients had TEAEs (CAE: 27 [42.2%]; JAE: 11 [55.0%]), 6 (7.1%) had drug‑related TEAEs (CAE: 4 [6.3%]; JAE: 2 [10.0%]), and 4 (4.8%) discontinued BRV due to TEAEs (CAE: 2 [3.1%]; JAE: 2 [10.0%]). The most common TEAE (≥ 10% of patients) was petit mal epilepsy (16.7%). On EEG, 52.6%/43.1%/42.3%/24.4% of patients had ASF at months 6/12/18/24 (Fig 1). Per daily seizure diary records, 34.5%/43.0%/43.1%/43.3%/40.3%/41.8%/34.0%/25.0%/28.6% had ASF between months 1-3/4-6/7-9/10-12/13-15/16-18/19-21/22-24/during the evaluation period (Fig 2).
Conclusions: Long-term BRV was well-tolerated and potentially efficacious in patients aged 2-26 yrs with CAE or JAE, and the results were consistent with the overall BRV safety profile. Further studies, including the completion of the ongoing core Phase 3 trial N01269, are needed to confirm the efficacy of BRV for treating CAE and JAE.
Funding: UCB-sponsored
Anti-seizure Medications