UCB SA — Briviact (in Italy: Nubriveo) EMA EPAR variation assessment report (EMEA/H/C/003898, 2016)
UCB SA · 2016 · EMA EPAR variation assessment report · company profile →
Report summary
This report summarizes the findings of the non-interventional prospective study EP0099, evaluating Brivaracetam (Briviact/Nubriveo) as an adjunctive therapy for partial-onset seizures in pediatric patients (4 to <18 years). Conducted in mid-European countries, the 12-month study assessed long-term utilization, effectiveness, and safety. Key findings include high brivaracetam retention rates, reasons for discontinuation, seizure freedom rates, and the percentage of patients achieving at least 50% seizure frequency reduction. Safety data, including treatment-emergent and drug-related adverse events, were consistent with brivaracetam's known safety profile.
Key findings — cited to the page
| Percentage of pediatric patients out of total recruited | 7 % | EP0099 · p.7 |
| Number of pediatric patients enrolled (APD Set) | 56 | EP0099 · p.6 |
| Median 28-day Baseline POS frequency (SS) | 3.33 | EP0099 · p.9 |
| Mean age of pediatric patients at Visit 1 (SS) | 11.9 years | EP0099 · p.7 |
| Percentage of pediatric patients aged 13 to <18 years (SS) | 51.8 % | EP0099 · p.7 |
| Percentage of pediatric patients discontinuing study prematurely due to lack of efficacy | 100.0 % | EP0099 · p.16 |
| Percentage of pediatric patients discontinuing brivaracetam treatment prematurely due to lack of efficacy | 77.8 % | EP0099 · p.16 |
| Brivaracetam retention rate | 83.9 % | EP0099 · p.17 |
| Brivaracetam retention rate (PPS) | 78.6 % | EP0099 · p.17 |
| Percentage of patients with lack of efficacy as reason for brivaracetam initiation | 89.3 % | EP0099 · p.15 |
| Percentage of pediatric patients completing 12-month study (SS) | 91.1 % | EP0099 · p.16 |
| brivaracetam retention rate | 96.4 % | EP0099 · p.18 |
Source: UCB SA ↗ · License: EMA - reuse permitted with acknowledgement. Summary and findings are extracted from the published document; every figure cites its page. Informational only — not investment advice. Explore the Neurology library →