A Randomized, Double-blind, Placebo-controlled, Multicenter, Parallel-group Study to Evaluate the Efficacy and Safety of Adjunctive Brivaracetam Subjects (>=16 to 80 Years of Age) With Partial Seizures With or Without Secondary Generalizatio
- Conditions
- Epilepsy and epilepsy syndrome
- Registration Number
- JPRN-jRCT2080223559
- Lead Sponsor
- CB Japan Co., Ltd.
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 444
Well-characterized focal epilepsy/epileptic syndrome according to the 1989 International League Against Epilepsy (ILAE) classification
- Presence of an electroencephalogram (EEG) reading compatible with the clinical diagnosis of focal epilepsy within the last 5 years
- Presence of a brain magnetic resonance imaging (MRI)/computed tomography (CT) scan performed within the last 2 years
- Subjects having at least 8 partial seizures (according to the 1981 ILAE classification) during the 8-Week Baseline Period with at least 2 partial seizures during each 4-week interval of the Baseline Period
- Subjects having at least 2 partial seizures whether or not secondary generalization per month during the 3 months preceding Visit 1
- Subjects uncontrolled while treated by 1 or 2 permitted concomitant antiepileptic drug [AED](s). Vagal Nerve Stimulation (VNS) is allowed and will be counted as a concomitant AED
- Permitted concomitant AED(s) and VNS being stable and at optimal dosage for the subject from at least 4 weeks (12 weeks for phenobarbital, phenytoin, and primidone) before Visit 1 and expected to be kept stable during whole study period
- Subject has history or presence of status epilepticus during the year preceding Visit 1 or during Baseline
- Subject has history of cerebrovascular accident, including transient ischemic attack, in the last 24 weeks
- Subject has history or presence of known psychogenic nonepileptic seizures
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>efficacy<br>- Partial seizure frequency per 28 days during the 12-week Treatment Period <br>Partial (Type I) seizures can be classified into one of the following three groups: Simple partial seizures, Complex partial seizures, Partial seizures evolving to secondarily generalized seizures.<br>- Adverse events (AEs)
- Secondary Outcome Measures
Name Time Method efficacy<br>pharmacokinetics<br>- 50% responder rate based on percent change in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period. <br>- Percent change in partial seizure frequency per 28 days from Baseline to the 12-week Treatment Period.<br>- Categorized percent change in partial seizures frequency per 28 days from Baseline to the 12-week Treatment Period.<br>- All seizure frequency (partial, generalized, and unclassified epileptic seizures) per 28 days during the 12-week Treatment Period.<br>- Percentage of subjects who are seizure free (partial, all epileptic seizures) during the 12-week Treatment Period.<br>- Brivaracetam plasma concentration