Actively Recruiting
A Multicenter, Open-Label, Single-Arm Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam in Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
Led by UCB Biopharma SRL · Updated on 2026-04-13
120
Participants Needed
23
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying the long-term safety and tolerability of brivaracetam in children and young people diagnosed with childhood absence epilepsy or juvenile absence epilepsy. This Phase 3 trial is open-label and single-arm, focusing on participants who have previously been involved in related studies and are expected to benefit from continued brivaracetam treatment. The study is sponsored by UCB Biopharma SRL and will run until March 2030. Participants will receive brivaracetam either as an oral solution or film-coated tablet, taken twice daily in equal doses. The study involves one treatment arm where various doses of brivaracetam are administered continuously. The treatment period can last up to three years, allowing researchers to observe the long-term effects of the medication. During the study, participants will be monitored for treatment-emergent adverse events, including serious side effects and any events leading to stopping the medication. Safety assessments will take place from the initial visit through up to three years of follow-up. The study will collect data on the frequency and nature of adverse events to evaluate the safety profile of brivaracetam over extended use in this young population.
CONDITIONS
Brief Title
A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study Participants With Childhood Absence Epilepsy or Juvenile Absence Epilepsy
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Participants must have previously taken part in EP0132 (NCT05109234) and/or N01269 (NCT04666610) and be eligible for this study as per those protocols
- Confirmed diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)
- Investigator expects a reasonable benefit from long-term brivaracetam use
- Male participants agree to use contraception during treatment and for 2 days after last dose and avoid sperm donation during this time
- Female participants must not be pregnant, not breastfeeding, and either not of childbearing potential or agree to use contraception during treatment and for 2 days after last dose
- Participants (or their parent/legal representative/caregiver if minors) provide informed consent or assent and agree to comply with study requirements
You will not qualify if you...
- History or presence of paroxysmal nonepileptic seizures
- Severe medical, neurological, or psychiatric disorders or lab abnormalities that could affect safe participation
- Hepatic impairment (Child Pugh Score A, B, or C) as assessed by the Investigator
- Active suicidal thoughts before study entry, as shown by specific assessment questions or clinical judgment
- Any medical or psychiatric condition that may compromise the ability to participate
- Known fructose intolerance or allergy to brivaracetam or similar drugs
- Use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin
- Use of other investigational drugs or devices alongside brivaracetam
- Ongoing serious adverse event or meeting withdrawal criteria from prior studies
- Poor compliance with study visits or medication intake in previous studies
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 3 years
Participants receive brivaracetam orally twice per day in various doses as either oral solution or film-coated tablets to evaluate long-term safety and tolerability.
Regular visits during treatment as per study schedule
Trial Site Locations
Total: 23 locations
1
Ep0224 50140
Birmingham, Alabama, United States, 35233-2110
Actively Recruiting
2
Ep0224 50639
Orange, California, United States, 92868
Actively Recruiting
3
Ep0224 50268
Miami, Florida, United States, 33155
Actively Recruiting
4
Ep0224 50638
New Brunswick, New Jersey, United States, 08901
Actively Recruiting
5
Ep0224 50640
Winston-Salem, North Carolina, United States, 27157
Actively Recruiting
6
Ep0224 20321
Tbilisi, Georgia
Actively Recruiting
7
Ep0224 20322
Tbilisi, Georgia
Actively Recruiting
8
Ep0224 20323
Tbilisi, Georgia
Active, Not Recruiting
9
Ep0224 20324
Tbilisi, Georgia
Active, Not Recruiting
10
Ep0224 40144
Abbiategrasso, Italy
Actively Recruiting
11
Ep0224 40765
Messina, Italy
Actively Recruiting
12
Ep0224 40764
Pavia, Italy
Actively Recruiting
13
Ep0224 40629
Roma, Italy
Completed
14
Ep0224 40766
Roma, Italy
Actively Recruiting
15
Ep0224 40763
Verona, Italy
Actively Recruiting
16
Ep0224 40767
Bucharest, Romania
Actively Recruiting
17
Ep0224 40769
Bucharest, Romania
Active, Not Recruiting
18
Ep0224 40768
Iași, Romania
Actively Recruiting
19
Ep0224 40770
Timișoara, Romania
Active, Not Recruiting
20
Ep0224 40771
Bardejov, Slovakia
Actively Recruiting
21
Ep0224 40772
Dubnica nad Váhom, Slovakia
Active, Not Recruiting
22
Ep0224 40453
Terrassa, Spain
Withdrawn
23
Ep0224 20328
Uzhhorod, Ukraine
Actively Recruiting
Research Team
U
UCB Cares
U
UCB Cares
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
Frequently Asked Questions
Have more questions? Get in touch with our team for quick support
Not the Right Trial for You?
Explore thousands of other clinical trials that might be a better match.
Sign up to get personalized trial recommendations delivered to your inbox.
Already have an account? Log in here