Actively Recruiting
A Study to Test the Long-term Safety and Tolerability of Brivaracetam in Study 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
294 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official 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 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 participants
- Male participants must agree to use contraception during treatment and for at least 2 days after the last dose and avoid donating sperm during this period
- Female participants must not be pregnant or breastfeeding and either not be of childbearing potential or agree to use contraception during treatment and for at least 2 days after the last dose
- Participants must be capable of and provide informed consent/assent, with parent/legal representative consent for minors, including compliance with study requirements
You will not qualify if you...
- History or presence of paroxysmal nonepileptic seizures
- Severe medical, neurological, or psychiatric disorders or lab values that may affect safe participation
- Hepatic impairment (Child Pugh Score A, B, or C) as assessed by Investigator
- Active suicidal ideation before study entry as indicated by Columbia-Suicide Severity Rating Scale or clinical judgment
- Any medical or psychiatric condition that could compromise participation
- Known fructose intolerance or hypersensitivity to brivaracetam or similar drugs
- Concomitant use of carbamazepine, felbamate, gabapentin, oxcarbazepine, phenobarbital, phenytoin, tiagabine, or vigabatrin
- Use of other investigational drugs or experimental devices in addition to brivaracetam
- Meeting mandatory withdrawal criteria from prior studies or ongoing serious adverse events
- Poor compliance with visit schedule or medication intake in prior studies as judged by Investigator
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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
CONTACT
U
UCB Cares
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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