A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participant
The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy.
| Condition(s) | Childhood Absence Epilepsy, Juvenile Absence Epilepsy |
|---|---|
| Status | Recruiting |
| Phase | Phase 3 |
| Study type | Interventional |
| Summary | The purpose of the study is to investigate the long-term safety and tolerability of brivaracetam in study participants with childhood absence epilepsy or juvenile absence epilepsy. |
| Who can participate | Inclusion Criteria: * Participants who previously participated in EP0132 (NCT05109234) and/or N01269 (NCT04666610) and qualify for entry into EP0224 as per the EP0132 or N01269 protocol with a confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE) * Participants for whom a reasonable benefit from long-term administration of Brivaracetam (BRV) is expected in the opinion of the Investigator * Male and female A male participant must agree to use contraception during the treatment period and for at least 2 days after the final dose of investigational medicinal product (IMP) and refrain from donating sperm during this period. A female participant is eligible to participate if she is not pregnant, not breastfeeding, and at least 1 of the following conditions a |
| Ages | 2 Years |
| Sex | All |
| Lead sponsor | UCB Biopharma SRL |
| Locations | Birmingham, Alabama, United States; Orange, California, United States; Miami, Florida, United States; New Brunswick, New Jersey, United States; Winston-Salem, North Carolina, United States; Tbilisi, Georgia (+17 more sites) |
| Start date | 2024-07-10 |
| NCT ID | NCT06315322 |
| Official listing | https://clinicaltrials.gov/study/NCT06315322 |