A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy
Focal Onset Seizures
About this trial
This is an interventional treatment trial for Focal Onset Seizures
Eligibility Criteria
Inclusion Criteria:
- Body mass index (BMI) between 18 and 35 kilogram per meter square (kg/m^2, inclusive (BMI = weight/height^2). Minimum body weight should be 40-kilogram (kg)
- Established diagnosis of focal epilepsy, for at least 1 year using the International League Against Epilepsy (ILAE) criteria. Participants should not be enrolled if they are known to have had fewer than 3 or more than 100 seizures in any monthly period in the past 6 months. It is preferred that participants have experience in maintaining a seizure e-diary
- 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; these procedures may be performed within the 8-week baseline period
- Cohort 1: Current treatment with at least 1 and up to 4 anti-epileptic drugs (AEDs) (including levetiracetam), administered at stable dosage(s) for at least 1 month before screening, and no new AEDs added for the previous 2 months; 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) 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 participants receiving brivaracetam will start when enrolling for Cohort 2
- Currently showing inadequate response to levetiracetam, administered at the appropriate dosage(s) and for a sufficient treatment period, based on the judgment of the investigator
- Healthy based on clinical laboratory tests, physical examination, medical history, vital signs, and 12-lead ECG
- Men or women between 18 and 69 years old
Exclusion Criteria:
- Have a generalized epileptic syndrome
- Diagnosis of Lennox-Gastaut Syndrome
- Currently experiencing seizures that cannot be counted accurately
- History of any current or past nonepileptic seizures, including psychogenic seizures
- Known allergies, hypersensitivity, or intolerance to placebo, JNJ-40411813 or its excipients
- Current treatment with vagus nerve stimulation, deep brain and cortical stimulation for 1 year or less
- Planned epilepsy surgery within the next 6 months or completed epilepsy surgery less than (<) 6 months ago
- Current treatment with vigabatrin
- History of malignancy within 5 years before screening (exceptions are squamous and basal cell carcinomas of the skin and carcinoma in situ of the cervix, or malignancy, which is considered cured with minimal risk of recurrence)
- Current or past (within the past year) major psychotic disorder, such as schizophrenia, bipolar disorder, or other psychotic conditions, recent (within the past 6 months) interictal psychosis, and major depressive disorder (MDD) with psychotic features
- Exacerbation of MDD within the past 6 months; antidepressant use is allowed
- Has a current or recent history of clinically significant suicidal ideation within the past 6 months, corresponding to a score of 4 (active suicidal ideation with some intent to act, without specific plan) or 5 (active suicidal ideation with specific plan and intent) for ideation on the Columbia Suicide Severity Rating Scale (C-SSRS), or a history of suicidal behavior within the past 1 year, as validated by the CSSRS at screening
- Has a history of at least mild drug or alcohol use disorder according to Diagnostic and Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 1 year before Screening
Sites / Locations
- Tucson Neuroscience Research
- Research Institution of Orlando, LLC
- Accel Research Sites
- Maine Medical CenterRecruiting
- Mid-Atlantic Epilepsy and Sleep CenterRecruiting
- Thomas Jefferson University HospitalRecruiting
- University of Virginia
- AZ Sint-JanRecruiting
- Cliniques Universitaires Saint-LucRecruiting
- UZ AntwerpenRecruiting
- Az GroeningeRecruiting
- UZ LeuvenRecruiting
- CHU UCL Namur - Site GodinneRecruiting
- Vivantes Humboldt Klinikum
- Krankenhaus Mara - BethelRecruiting
- Universitatsklinikum Bonn
- Universitaetsklinik Erlangen
- Universitaetsklinikum Frankfurt
- Diakonie Kork - EpilepsiezentrumRecruiting
- Universitaetsklinikum Giessen und Marburg GmbHRecruiting
- Chungnam National University Hospital
- Seoul National University HospitalRecruiting
- Severance Hospital, Yonsei University Health SystemRecruiting
- Konkuk University Medical CenterRecruiting
- Asan Medical CenterRecruiting
- Samsung Medical CenterRecruiting
- Centrum Medyczne Neuromed Sp z o. o.Recruiting
- Copernicus Podmiot Leczniczy Sp. z o.oRecruiting
- NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'Recruiting
- Centrum Terapii SMRecruiting
- NEURO-MEDIC Janusz Zbrojkiewicz Poradnia WielospecjalistycznaRecruiting
- Specjalistyczne Gabinety LekarskieRecruiting
- Centrum Leczenia Padaczki i Migreny. NZOZ
- Centrum Opieki Zdrowotnej Orkan-med Stec-Michalska sjRecruiting
- Clinical Best Solutions Sp. z o.o., Sp. K.Recruiting
- Twoja Przychodnia - Centrum Medyczne Nowa SolRecruiting
- Clinical Research Center sp. z o.o MEDIC-R s.k.
- NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partnerska LekarzyRecruiting
- MTZ Clinical Research Powered by PratiaRecruiting
- NeurospheraRecruiting
- Institute of Psychiatry and NeurologyRecruiting
- Centrum Medyczne OporowRecruiting
- ProNeuro Centrum MedyczneRecruiting
- Republic Clinical Hospital
- Research Medical Center Your Health
- Specialized clinical psychiatric hospital #1
- Clinical City Hospital #1
- Nizny Novgorod clinical psychiatric hospital 1
- SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky
- Smolensk Regional Clinical Hospital
- Psychoneurological Dispensary of Frunzensky District
- St-Petersburg Bekhterev Psychoneurological Research Institute
- Yaroslavl State Medical University
- Hosp. Del MarRecruiting
- Hosp. Univ. Vall D HebronRecruiting
- Hosp. Clinic I Provincial de BarcelonaRecruiting
- Hosp. de La Santa Creu I Sant PauRecruiting
- Hosp. Univ. de La PrincesaRecruiting
- Hosp. Regional Univ. de MalagaRecruiting
- Centro Neurologia Avanzada SevillaRecruiting
- Hosp. Mutua TerrassaRecruiting
- Centro de Inv. Avanzada NeurocienciasRecruiting
- Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
- Medical Center of Private Enterprise Neuron
- Cnce of Lviv Regional Council 'Lviv Regional Clinical Hospital'
- Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'
- Mnce 'Ternopil Regional Clinical Psychoneurology Hospital' of Trb
- Llc Diamed Medical Center
- Cnpe 'Vinnytsia Regional Clinical Psycho-Neurological Hospital N.A. Ac. O.I. Yushchenko' of Vrc
Arms of the Study
Arm 1
Arm 2
Experimental
Placebo Comparator
JNJ-40411813
Placebo
Participants will receive JNJ-40411813 twice a day (bid) up to 12 weeks in double blind period. Up to 3 different doses (low, medium, high) of JNJ-40411813 will be administered in this study. Participants will also receive concomitant anti-epileptic drugs (AEDs) one of which must include levetiracetam or brivaracetam. Immediately after the last study drug intake by the participants in the double-blind period, participants will enter into a 2-year open label extension (OLE) period and continue receiving JNJ-40411813 as well as the AEDs during OLE period.
Participants will receive JNJ-40411813 matching placebo (bid) up to 12 weeks. Participants will also receive concomitant AEDs one of which must include levetiracetam or brivaracetam during double blind period. Participants who had been receiving placebo in double blind period will start with the JNJ-40411813 dose in the OLE period.