A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
Recruiting · NCT04715646 · Interventional (participants receive a specific treatment) · Lead sponsor: UCB Biopharma SRL
View the official record on ClinicalTrials.gov →Interventions studied
Brivaracetam
What this trial is about
The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.
Who can take part
Age range
1 Month and older
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Phase 3
Study type
Interventional (participants receive a specific treatment)
Inclusion criteria
- Inclusion criteria for long-term follow-up (LTFU) study participants only
- Study participants ≥ 1 month of age with a confirmed diagnosis of epilepsy who participated in core study N01266 \[NCT01364597\] and/or N01349 \[NCT03325439\]
- Inclusion criteria for directly enrolled (DE) study participants in Japan only
- Study participant is ≥ 4 years to \< 16 years of age
- Study participant has presence of an electroencephalogram (EEG) reading compatible with the diagnosis of focal epilepsy within the last 10 years
- Study participant has uncontrolled partial-onset seizure (POS) after an adequate course of treatment with at least 1 antiepileptic drug (AED)
- Study participant had at least 1 POS during the 4-week Screening Period
Exclusion criteria
- Exclusion criteria for all study participants
- Severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant
- Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV).
- Exclusion criteria for long-term follow-up (LTFU) study participants only
- \- Study participant ≥ 6 years of age has a lifetime history of suicide attempt or has suicidal ideation in the past 6 months as indicated on the Columbia Suicide Severity Rating Scale (C-SSRS)
- Exclusion criteria for directly enrolled (DE) study participants in Japan only
- Study participant has a history of primary generalized epilepsy, psychogenic non-epileptic seizures, or febrile seizures
- Study participant has a history of status epilepticus in the 30 days prior to the Screening Visit (ScrV) or during the Screening Period
- Study participant has any clinically significant illness
- Study participant has clinically significant laboratory abnormality that may increase the risk associated with study participation or may interfere with the interpretation of study results
- Study participant has a clinically significant ECG abnormality
- Study participant had major surgery within 6 months prior to the ScrV
Where it is running
36 locations listed across 2 US states.
- Ep0156 259 - Hawthorne, New York, United States
- Ep0156 237 - Durham, North Carolina, United States
- Ep0156 223 - Aguascalientes, Mexico
- Ep0156 210 - Budapest, Hungary
- Ep0156 247 - Budapest, Hungary
- Ep0156 803 - Bunkyō City, Japan
- Ep0156 808 - Chūō, Japan
- Ep0156 609 - Culiacán, Mexico
- Ep0156 209 - Freiburg im Breisgau, Germany
- Ep0156 800 - Gifu, Japan
- Ep0156 603 - Guadalajara, Mexico
- Ep0156 807 - Hiroshima, Japan
- Ep0156 406 - Kielce, Poland
- Ep0156 815 - Kodaira-shi, Japan
- Ep0156 402 - Krakow, Poland
- Ep0156 806 - Kyoto, Japan
- Ep0156 813 - Kōshi, Japan
- Ep0156 204 - Leuven, Belgium
- Ep0156 207 - Loos, France
- Ep0156 232 - Miskolc, Hungary
- Ep0156 811 - Nagoya, Japan
- Ep0156 812 - Niigata, Japan
- Ep0156 817 - Osaka, Japan
- Ep0156 401 - Poznan, Poland
- Ep0156 240 - Prague, Czechia
- Ep0156 230 - Roma, Italy
- Ep0156 805 - Sapporo, Japan
- Ep0156 816 - Sendai, Japan
- Ep0156 248 - Seville, Spain
- Ep0156 809 - Shimotsuke, Japan
- Ep0156 814 - Shizuoka, Japan
- Ep0156 804 - Tokyo, Japan
- Ep0156 810 - Yokohama, Japan
- Ep0156 802 - Yonago, Japan
- Ep0156 818 - Ōbu, Japan
- Ep0156 819 - Ōmura, Japan