Trial reportAdvances in therapy2025
Safety, Tolerability, and Efficacy of Adjunctive Brivaracetam in Japanese and Chinese Patients with Focal-Onset Seizures: Interim Analysis of a Phase 3 Open-Label Extension Trial.
Trial report in Advances in therapy, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03250377 (An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization), which is not on this map. Cited by 2 papers.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
An Open-Label, Multicenter, Follow-up Study to Evaluate the Long-Term Safety and Efficacy of Brivaracetam Used as Adjunctive Treatment in Subjects >=16 Years of Age With Partial Seizures With or Without Secondary Generalization
Who cites it
2 citing papers in PubMed.
- Safety, Tolerability, and Efficacy of Adjunctive Brivaracetam in Japanese and Chinese Patients with Focal-Onset Seizures: Interim Analysis of a Phase 3 Open-Label Extension Trial.Advances in therapy · 2025Trial
- First-year Experience with Brivaracetam in Japan: Real-world Data from Juntendo Epilepsy Center.Neurologia medico-chirurgica · 2026Article
Corrections and comments
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Authors and funding
11 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
introductionThis trial evaluated long-term safety, tolerability, and maintenance of efficacy of adjunctive brivaracetam (BRV) in Japanese and Chinese patients aged ≥ 16 years with focal-onset seizures (FOS).
methodsInterim analysis of data from EP0085 (NCT03250377), a long-term follow-up trial of adjunctive BRV 50-200 mg/day in Japanese and Chinese patients. Post hoc analyses assessed efficacy for 12- and 24-month completers and BRV retention.
resultsAt data cutoff (June 1, 2023), 207 patients had enrolled; of these, 157 (75.8%) were ongoing and 50 (24.2%) had discontinued. Overall, 137 patients were 12-month completers and 63 were 24-month completers. Mean age was 36.7 years and 107 (51.7%) patients were female (100 [48.3%] male). Mean duration of epilepsy was 17.16 years. At data cutoff, total duration of BRV exposure was 378.5 patient-years. Mean duration of BRV exposure was 667.8 days (median 427.0 days), with a median modal dose of 200.0 mg/day (range 25.0-200.0 mg/day). Kaplan-Meier-estimated BRV retention rates at 12, 24, and 36 months were 85%, 76%, and 68%, respectively. Treatment-emergent adverse events (TEAEs) were reported by 184 (88.9%) patients, drug-related TEAEs by 60 (29.0%), serious TEAEs by 29 (14.0%), and 8 (3.9%) discontinued as a result of TEAEs. Median FOS frequency/28 days decreased from 7.59 during baseline to 4.11 during the evaluation period. For the overall evaluation period, 12-month, and 24-month completers, median percentage reductions from baseline in FOS frequency/28 days were 42.4%, 44.0%, and 38.9%, respectively, and 50% responder rates were 46.4%, 46.7%, and 38.1%.
conclusionBased on this interim and post hoc analysis, long-term adjunctive BRV was well tolerated and efficacious in Japanese and Chinese patients with FOS. The efficacy response was maintained over time in those completing 12 and 24 months of trial participation. Overall, 68% of patients remained on BRV treatment for 3 years.
trial registrationClinicalTrials.gov NCT03250377. Graphical abstract available for this article.
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