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Open-Label, Single-Arm, Multicenter Study to Evaluate Long-Term Safety and Tolerability of Brivaracetam Used as Adjunctive Treatment in Pediatric Study Participants With Epilepsy (An open-label, long-term safety and tolerability study of brivaracetam as adjunctive treatment in pediatric study participants with epilepsy)

A study to test the safety and tolerability of brivaracetam in pediatric study participants with seizures

Pyko Ilya

ICON Clinical Research GK

Sumitomo ShinToranomon Bldg. 4-3-9 Toranomon, Minato-ku, Tokyo 105-0001, Japan

ilya.pyko@iconplc.com

Global Clinical Science & Operation

UCB Japan Co., Ltd.

8-17-1 Nishi-shinjuku, Shinjuku-ku, Tokyo, 160-0023

+81-3-6864-7587

CTR_SCC_UCBJapan@UCB.com

Recruiting

Jan. 27, 2021

Interventional

single arm study

open(masking not used)

uncontrolled control

single assignment

treatment purpose

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] 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 >= 1 month 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 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 end-stage kidney disease requiring dialysis or any medical condition including chronic liver disease (Child Pugh Score A, B, or C), 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

Both

Epilepsy

Brivaracetam (BRV) tablets or oral solution will be administered twice daily (bid) in 2 equally divided doses.
Tablets
Concentration: 10 mg, 25 mg, 50 mg
Route of administration: oral
Oral solution
Concentration: 10 mg/ml
Route of administration: oral

1. Incidence of treatment-emergent adverse events (TEAEs) during the study
2. Incidence of treatment-emergent serious adverse events (SAEs) during the study
3. Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study

+81-58-246-1111

Dec. 14, 2020

Yes

Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe, or global development is discontinued, and 18 months after trial completion. Investigators may request access to anonymized individual patient-level data and redacted trial documents which may include: analysis-ready datasets, study protocol, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed. All documents are available in English only, for a prespecified time, typically 12 months, on a password protected portal. This plan may change if the risk of re-identifying trial participants is determined to be too high after the trial is completed; in this case and to protect participants, individual patient-level data would not be made available. IPD Time Frame : Data from this trial may be requested by qualified researchers six months after product approval in the US and/or Europe or global development is discontinued, and 18 months after trial completion. IPD Access Criteria : Qualified researchers may request access to anonymized IPD and redacted study documents which may include: raw datasets, analysis-ready datasets, study protocol, blank case report form, annotated case report form, statistical analysis plan, dataset specifications, and clinical study report. Prior to use of the data, proposals need to be approved by an independent review panel at www.Vivli.org and a signed data sharing agreement will need to be executed.All documents are available in English only, for a pre-specified time, typically 12 months, on a password protected portal.

BEL/CZE/FRA/DEU/HUN/ITA/IRL /MEX/POL /ESP/GBR/USA