A study to test the safety and tolerability of brivaracetam in pediatric study participants withseizures.
- Conditions
- EpilepsyMedDRA version: 21.0Level: PTClassification code 10015037Term: EpilepsySystem Organ Class: 10029205 - Nervous system disordersTherapeutic area: Diseases [C] - Nervous System Diseases [C10]
- Registration Number
- EUCTR2020-003664-29-PL
- Lead Sponsor
- CB Biopharma SR
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- All
- Target Recruitment
- 79
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
Are the trial subjects under 18? yes
Number of subjects for this age range: 79
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 4
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range
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 (CSSRS)
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
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Main Objective: To evaluate the long-term safety and tolerability of BRV<br>;Secondary Objective: Not applicable<br>;Primary end point(s): 1. Incidence of treatment-emergent adverse events (TEAEs) during the study;<br>2. Incidence of treatment-emergent serious adverse events (SAEs) during the study;<br>3. Incidence of treatment-emergent adverse events (TEAEs) leading to discontinuation of study drug during the study.;Timepoint(s) of evaluation of this end point: 1-3. From Entry Visit (Day 1) until Safety Visits (up to 5 years)
- Secondary Outcome Measures
Name Time Method Secondary end point(s): Not applicable;Timepoint(s) of evaluation of this end point: Not applicable