A Study to Test the Safety and Tolerability of Brivaracetam in Pediatric Study Participants With Seizures

  • STATUS
    Recruiting
  • End date
    Apr 1, 2025
  • participants needed
    100
  • sponsor
    UCB Biopharma SRL
Updated on 4 August 2021
Investigator
UCB Cares
Primary Contact
Ep0156 232 (0.0 mi away) Contact
+21 other location
seizure
electroencephalogram
antiepileptics
brivaracetam

Summary

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

Description

EP0156 is designed to assess the long-term safety and tolerability of brivaracetam (BRV) from pediatric study participants with epilepsy who participated in the study in neonates, N01349 [NCT03325439], and/or the ongoing, open-label, long-term, follow-up study in pediatric study participants, N01266 [NCT01364597], who have the opportunity to continue BRV treatment by participating in EP0156.

EP0156 is also designed to assess the long-term safety and tolerability of BRV from directly enrolled (DE) Japanese pediatric study participants with partial-onset seizures (POS) recruited in Japan. In the DE study participants only, pharmacokinetic (PK) data will be evaluated in addition to the safety and tolerability of BRV.

Details
Condition Epilepsy, Seizure Disorders (Pediatric), Seizure Disorders, epileptic, seizure disorder, epilepsia, epileptics
Treatment Brivaracetam
Clinical Study IdentifierNCT04715646
SponsorUCB Biopharma SRL
Last Modified on4 August 2021

Eligibility

Yes No Not Sure

Inclusion Criteria

Inclusion criteria for long-term follow-up (LTFU) study participants only
Study participants with a confirmed diagnosis of epilepsy who participated in core study N01266 [NCT01364597] and/or N01349 [NCT03325439] and for whom a reasonable benefit from long-term administration of brivaracetam (BRV) is expected
Inclusion criteria for directly enrolled (DE) study participants 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 (in the opinion of the Investigator) with at least 1 antiepileptic drug (AED)
Study participant had at least 1 POS during the 4-week Screening Period
Study participant is taking at least 1 AED. Vagal nerve stimulator will be counted as a concomitant AED

Exclusion Criteria

Exclusion criteria for all study participants
Study participant has, in the Investigator's opinion, severe medical, neurological, or psychiatric disorders or laboratory values, which may have an impact on the safety of the study participant
Study participant has any medical condition including chronic liver disease, which in the Investigator's opinion, warrants exclusion
Study participant is currently participating in another study of an investigational medication (or a medical device) other than brivaracetam (BRV). The use of antiepileptic drugs (AEDs) marketed for adults but not approved for pediatric use is not considered to be "investigational" for the purposes of this study
Sensitivity to any of the study interventions, or components thereof, or drug or other allergy that, in the opinion of the Investigator or medical monitor, contraindicates participation in the study
Exclusion criteria for long-term follow-up (LTFU) study participants only
Study participant had poor compliance with the visit schedule or medication intake in the BRV core study
Study participant 6 years of age has a lifetime history of suicide attempt (including an actual attempt, interrupted attempt, or aborted 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 only
Study participant has a history of primary generalized epilepsy
Study participant has a history of status epilepticus in the 30 days immediately prior to the Screening Visit (ScrV) or during the Screening Period
Study participant has history or presence of known psychogenic nonepileptic seizures
Study participant has experienced febrile seizures exclusively. The occurrence of febrile seizures in addition to other unprovoked seizures is not exclusionary
Study participant has any clinically significant acute or chronic illness as determined during the physical examination or from other information available to the Investigator (eg, bone marrow suppression, chronic hepatic disease, severe renal impairment, psychiatric disorder as per Investigator assessment)
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, according to the judgment of the Investigator
Study participant has a clinically significant ECG abnormality according to the Investigator
Study participant had major surgery within 6 months prior to the ScrV
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