Childhood absence epilepsy and juvenile absence epilepsy
Conditions
Interventions
Trade Name: Briviact
Pharmaceutical Form: Oral solution
INN or Proposed INN: BRIVARACETAM
CAS Number: 357336-20-0
Current Sponsor code: BRV
Other descriptive name: ucb 34714
Concentration unit: mg/ml
Sponsors
UCB Biopharma SRL
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: -Study participant is 2 to 25 years of age inclusive, at the time of signing the informed consent. No study participants from 2 to =65 years) no F.1.3.1 Number of subjects for this age range 0
Exclusion criteria
Exclusion criteria: -Study participant has a history of nonfebrile seizures other than absence seizures (eg, generalized tonic-clonic seizures or myoclonic seizures) -Study participant has a history of absence status epilepticus -Study participant has a history or presence of paroxysmal nonepileptic seizures -Study participant has a clinically relevant electrocardiogram (ECG) abnormality in the opinion of the Principal Investigator -Study participant has hepatic impairment (Child Pugh Score A, B, or C) based on the Investigator’s assessment -Study participant has a history of major psychiatric disease or any clinically significant medical condition that would preclude appropriate study participation -Study participant has active suicidal ideation prior to study entry as indicated by a positive response (“Yes”) to either Question 4 or Question 5 of the Columbia-Suicide Severity Rating Scale (C-SSRS; for study participants 6 years or older) or clinical judgement (for study participants younger than 6 years). The study participant should be referred immediately to a Mental Healthcare Professional -Study participant has a lifetime history of suicide attempt (including an active attempt, interrupted attempt, or aborted attempt). The study participant should be immediately evaluated by a Mental Healthcare Professional to address safety concerns -Study participant with known fructose intolerance or hypersensitivity of any of the ingredients in brivaracetam oral solution -Study participant has end-stage kidney disease requiring dialysis -Concomitant use of rifampicin/rifampin; prior use must have been stopped at least 2 months before randomization -Concomitant use of strong CYP2C19 inhibitors like fluconazole, fluoxetine and fluvoxamine, prior use must have been stopped at least 1 week before randomization -Study participant has participated in another study of an investigational medicinal product (IMP; and/or an investigational device) within the previous 30 days prior to informed consent -Study participant has clinical or EEG findings not consistent with a diagnosis of childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Investigate the efficacy of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive, with childhood absence epilepsy (CAE) or juvenile absence epilepsy (JAE);Secondary Objective: Evaluate the safety and tolerability of brivaracetam monotherapy in study participants 2 to 25 years of age inclusive, with CAE or JAE;Primary end point(s): Percentage of participants who met the criteria for absence seizure freedom within 4 days prior to or during the 24-hour ambulatory electroencephalogram (EEG) at Day 14 ;Timepoint(s) of evaluation of this end point: Day 14 | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1. Percentage of participants who met the criteria for absence seizure freedom during the randomized withdrawal (RDW) period as determined by electroencephalogram (EEG) 2. Percent change from Baseline to Day 14 in number of absence seizures on 24-hour ambulatory electroencephalogram (EEG) 3. Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Day 14 4. Percentage of participants who met the criteria for absence seizure freedom on 24-hour ambulatory electroencephalogram (EEG) at Week 12 5. Percentage of participants who met the criteria for absence seizure freedom based on diary during the 4 days prior to the visit at Week 12 6. Percentage of participants with treatment-emergent adverse events (TEAEs) during the study 7. Percentage of participants with treatment-emergent adverse events (TEAEs) leading to discontinuation of study treatment 8. Percentage of participants with serious adverse events (SAEs) during the study 9. Percentage of participants with drug-related treatment-emergent adverse events (TEAEs) during the study;Timepoint(s) of evaluation of this end point: 1. From Week 13 to Week 17 2. From Baseline to Day 14 3. Day 14 4.; 5. Week 12 6.; 9.: From Day 1 until End of Safety Follow-Up (up to Week 23) 7. From Day 1 until End of Down Titration Period (up to Week 21) 8. From Screening Period (Day -14 to Day -2) until End of Safety Follow-Up (up to Week 23) | — |
Countries
Australia, Belgium, Georgia, Italy, Poland, Romania, Slovakia, Spain, Ukraine, United States
Contacts
Public ContactClin Trial Reg & Results Disclosure
UCB BIOSCIENCES GmbH
Outcome results
None listed