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A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures
A Study to Test the Safety and Tolerability of Brivaracetam in Children and Adolescents With Seizures

NCT04715646

RecruitingPhase 3

Sponsor: UCB Biopharma SRL

Conditions: Epilepsy

Interventions: Brivaracetam

Countries: United States, Belgium, Czechia, France, Germany, Hungary, Italy, Japan

The purpose of the study is to evaluate the long-term safety and tolerability of brivaracetam.

Eligibility overview

Sex: ALL

Age: 1 Month to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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
Locations (36)
  • Hawthorne, New York, United States
  • Durham, North Carolina, United States
  • Leuven, Belgium
  • Prague, Czechia
  • Loos, France
  • Freiburg im Breisgau, Germany
  • Budapest, Hungary
  • Budapest, Hungary
  • Miskolc, Hungary
  • Roma, Italy
  • Bunkyō City, Japan
  • Chūō, Japan
  • Gifu, Japan
  • Hiroshima, Japan
  • Kodaira-shi, Japan
  • Kōshi, Japan
  • Kyoto, Japan
  • Nagoya, Japan
  • Niigata, Japan
  • Osaka, Japan
  • Ōbu, Japan
  • Ōmura, Japan
  • Sapporo, Japan
  • Sendai, Japan
  • Shimotsuke, Japan
  • Shizuoka, Japan
  • Tokyo, Japan
  • Yokohama, Japan
  • Yonago, Japan
  • Aguascalientes, Mexico
  • + 6 more on CT.gov