Focal Onset Seizures MedDRA version: 21.0 Level: PT Classification code 10015037 Term: Epilepsy System Organ Class: 10029205 - Nervous system disorders MedDRA version: 21.1 Level: LLT Classification code 10065337 Term: Focal epilepsy System Organ Class: 10029205 - Nervous system disorders
Conditions
Interventions
Product Name: JNJ-40411813
Product Code: JNJ-40411813
Pharmaceutical Form: Tablet
INN or Proposed INN: not applicable
CAS Number: 1127498-036
Current Sponsor code: JNJ-40411813
Other descriptive name:
Sponsors
Janssen-Cilag International NV
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Participants must be men or women, 18 to 69 years of age, inclusive. 2. Body Mass Index (BMI) between 18 and 35 kg/m2 inclusive (BMI=weight/height2). Minimum body weight should be 40 kg. 3. Established diagnosis of focal epilepsy, for at least 1 year using the International League Against Epilepsy (ILAE) criteria (Fisher 2017). 4. Must have had a neuroimaging procedure within 10 years, including a computed tomography (CT) scan or magnetic resonance imaging (MRI), that excluded a progressive neurologic disorder. 5. Cohort 1: Current treatment with at least 1 and up to 4 AEDs (including levetiracetam), administered at the appropriate dosage(s) and for a sufficient treatment period before screening, these AEDs must remain unchanged throughout the pretreatment. Cohort 2 and beyond: Current treatment with at least 1 and up to 4 AEDs (including levetiracetam or brivaracetam), administered at the appropriate dosage(s) and for a sufficient treatment period before screening. These AEDs must remain unchanged throughout the pretreatment and double-blind treatment periods (with the exception of dosage reductions of concomitant AEDs because of suspected elevated AED levels or side effects). Important note: screening of patients receiving Brivaracetam will start when enrolling for Cohort 2. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 100 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 60
Exclusion criteria
Exclusion criteria: 1. Have a generalized epileptic syndrome. 2. Diagnosis of Lennox-Gastaut Syndrome. 3. Currently experiencing seizures that cannot be counted accurately. 4. History of any current or past nonepileptic seizures, including psychogenic seizures. 5. Recently initiated vagus nerve stimulation, deep brain and cortical stimulation.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: The primary objective of this study is to evaluate the efficacy of adjunctive JNJ 40411813 compared to placebo in participants with focal onset seizures who are receiving levetiracetam or brivaracetam and up to 3 other anti-epileptic drugs (AEDs);Secondary Objective: -To evaluate the overall safety and tolerability of adjunctive JNJ-40411813 compared to placebo in participants with focal onset seizures who are receiving levetiracetam or brivaracetam and up to 3 other AEDs. -To evaluate the efficacy of adjunctive JNJ-40411813 compared to placebo in participants with focal onset seizures. -To evaluate the efficacy of JNJ-40411813 over the double-blind period -To evaluate the pharmacokinetics (PK) of JNJ-40411813;Primary end point(s): Time to baseline monthly seizure count.;Timepoint(s) of evaluation of this end point: Baseline, up to 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1-Adverse events, significant changes in vital signs, ECG and safety laboratory results. 2-Percent reduction in the double-blind monthly seizure count. 3-Percent participants with seizure freedom and percent responders (>50% seizure rate reduction). 4-Plasma concentrations of JNJ-40411813. ;Timepoint(s) of evaluation of this end point: 1-Full study period. 2-Baseline, up to 12 weeks. 4-Various timepoints over treatment period. | — |
Countries
Belgium, Germany, Korea, Republic of, Poland, Russian Federation, Spain, Ukraine, United States
Contacts
Public ContactClinical Registry Group
Janssen-Cilag International NV
Outcome results
None listed