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A multicenter, open-label, single-arm study to evaluate long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
EU CTIS
Registry ID
CTIS2023-508095-11-00
Acronym
EP0224
Enrollment
31
Registered
2024-07-19
Start date
2024-11-27
Completion date
Unknown
Last updated
2025-08-05

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Childhood Absence Epilepsy, Juvenile Absence Epilepsy

Brief summary

- Incidence of treatment-emergent adverse events (TEAEs) during the study - Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of investigational medicinal product (IMP) during the study

Detailed description

- Incidence of serious adverse events (SAEs) during the study - Incidence of IMP related TEAEs during the study

Interventions

DRUGbrivaracetam

Sponsors

UCB Biopharma
Lead SponsorINDUSTRY

Eligibility

Sex/Gender
All
Age
0 Years to 64 Years

Design outcomes

Primary

MeasureTime frame
- Incidence of treatment-emergent adverse events (TEAEs) during the study - Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of investigational medicinal product (IMP) during the study

Secondary

MeasureTime frame
- Incidence of serious adverse events (SAEs) during the study - Incidence of IMP related TEAEs during the study

Countries

Italy, Romania, Slovakia, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026