A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy

Conditions

• Childhood Absence Epilepsy
• Juvenile Absence Epilepsy

Eligibility Criteria

Sex

ALL

Age

2 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Brivaracetam Film-coated tablet — DRUG
  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.
• Brivaracetam oral solution — DRUG
  Pharmaceutical form: Oral solution Route of administration: Oral use Brivaracetam oral solution \[10 mg/mL\]) will be administered twice per day in equal doses.

Study Details

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.

Key Dates

Start date

Jul 10, 2024

Status verified

Apr 2026

Primary completion

Mar 1, 2030

Completion

Mar 1, 2030

Study Design

Enrollment

120 participants (estimated)

Allocation

NA

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Arms

• Experimental: Brivaracetam arm
  Subjects in this arm will receive various brivaracetam doses as oral solution or film-coated tablet twice per day.

Primary Outcome Measure

Incidence of treatment-emergent adverse events (TEAEs) during the study [ Time Frame: From Entry Visit up to the Safety Visit (up to 3 years) ]

Central Contacts

• UCB Cares
  1-844-599-2273 (USA)
  [email protected]
• UCB Cares
  001 844 599 2273
  [email protected]

Locations (5)

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