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
UCB Biopharma SRL
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.
Eligibility
- Age range
- 2+ years
- Sex
- All
- Healthy volunteers
- No
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…
Interventions
- DrugBrivaracetam Film-coated tablet
Drug: Brivaracetam Film-coated tablet Pharmaceutical form: Film-coated tablet Route of administration: Oral use Brivaracetam film-coated tablet \[10, 25 or 50 mg\] will be administered twice per day in equal doses.
- DrugBrivaracetam oral solution
Pharmaceutical form: Oral solution Route of administration: Oral use Brivaracetam oral solution \[10 mg/mL\]) will be administered twice per day in equal doses.
Locations (23)
- Ep0224 50140Birmingham, Alabama
- Ep0224 50639Orange, California
- Ep0224 50268Miami, Florida
- Ep0224 50638New Brunswick, New Jersey
- Ep0224 50640Winston-Salem, North Carolina
- Ep0224 20321Tbilisi