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

UCB

Status and phase: Enrolling; Phase 3

Conditions: Epilepsy

Treatments: Drug: Brivaracetam

Study type: Interventional

Funder types: Industry

Identifiers

NCT04715646

EP0156

2020-003664-29 (EudraCT Number)

Details and patient eligibility

About

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

Full description

EP0156 is designed to assess the long-term safety and tolerability of BRV in pediatric study participants with epilepsy who participated in the neonatal study N01349 [NCG03325439] and/or have participated in the open-label, long-term, follow-up pediatric study N01266 [NCT01364597]. EP0156 will also assess the long-term safety and tolerability of BRV in Japanese pediatric study participants with partial-onset seizures who will be directly enrolled into the study in Japan. Pharmacokinetic data will also be evaluated in Japanese study participants.

Enrollment: 70 estimated patients

Sex: All

Ages: 1+ month old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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70 participants in 1 patient group

Brivaracetam

Experimental group

Description:

LTFU study participants: Up to 5mg/kg/day (for study participants weighing 11kg to less than 20kg) and up to 4mg/kg/day (for study participants weighing 20kg to less than 50kg) and no more than 200mg/day Directly enrolled (DE) study participants: 1mg/kg/day to 4mg/kg/day and no more than 200mg/day.

Treatment:

Drug: Brivaracetam