Phase
Condition
N/ATreatment
Placebo
JNJ-40411813
Clinical Study ID
Ages 18-69 All Genders
Study Summary
Eligibility Criteria
Inclusion
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 InternationalLeague Against Epilepsy (ILAE) criteria. Participants should not be enrolled if theyare known to have had fewer than 3 or more than 100 seizures in any monthly periodin the past 6 months. It is preferred that participants have experience inmaintaining a seizure e-diary
Must have had a neuroimaging procedure within 10 years, including a computedtomography (CT) scan or magnetic resonance imaging (MRI), that excluded aprogressive neurologic disorder; these procedures may be performed within the 8-weekbaseline 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 monthbefore screening, and no new AEDs added for the previous 2 months; these AEDs mustremain unchanged throughout the pretreatment and double-blind treatment periods (with the exception of dosage reductions of concomitant AEDs because of suspectedelevated AED levels or side effects) Cohort 2 and beyond: Current treatment with atleast 1 and up to 4 AEDs (including levetiracetam or brivaracetam), administered atthe appropriate dosage(s) and for a sufficient treatment period before screening.These AEDs must remain unchanged throughout the pretreatment and double-blindtreatment periods (with the exception of dosage reductions of concomitant AEDsbecause of suspected elevated AED levels or side effects). Important note: screeningof participants receiving brivaracetam will start when enrolling for Cohort 2
Currently showing inadequate response to levetiracetam, administered at theappropriate dosage(s) and for a sufficient treatment period, based on the judgmentof 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
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 itsexcipients
Current treatment with vagus nerve stimulation, deep brain and cortical stimulationfor 1 year or less
Planned epilepsy surgery within the next 6 months or completed epilepsy surgery lessthan (<) 6 months ago
Current treatment with vigabatrin
History of malignancy within 5 years before screening (exceptions are squamous andbasal cell carcinomas of the skin and carcinoma in situ of the cervix, ormalignancy, which is considered cured with minimal risk of recurrence)
Current or past (within the past year) major psychotic disorder, such asschizophrenia, bipolar disorder, or other psychotic conditions, recent (within thepast 6 months) interictal psychosis, and major depressive disorder (MDD) withpsychotic features
Exacerbation of MDD within the past 6 months; antidepressant use is allowed
Has a current or recent history of clinically significant suicidal ideation withinthe past 6 months, corresponding to a score of 4 (active suicidal ideation with someintent to act, without specific plan) or 5 (active suicidal ideation with specificplan 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 bythe CSSRS at screening
Has a history of at least mild drug or alcohol use disorder according to Diagnosticand Statistical Manual of Mental Disorders (5th edition) (DSM-5) criteria within 1year before Screening
Study Design
Study Description
Connect with a study center
AZ Sint-Jan
Brugge, 8000
BelgiumSite Not Available
Cliniques Universitaires Saint Luc
Bruxelles, 1200
BelgiumSite Not Available
Cliniques Universitaires Saint-Luc
Bruxelles, 1200
BelgiumSite Not Available
UZ Antwerpen
Edegem, 2650
BelgiumSite Not Available
Az Groeninge
Kortrijk, 8500
BelgiumSite Not Available
UZ Leuven
Leuven, B-3000
BelgiumSite Not Available
CHU UCL Namur - Site Godinne
Yvoir, 5530
BelgiumSite Not Available
Vivantes Humboldt Klinikum
Berlin, 13509
GermanySite Not Available
Krankenhaus Mara - Bethel
Bielefeld, 33617
GermanySite Not Available
Universitatsklinikum Bonn
Bonn, 53127
GermanySite Not Available
Universitaetsklinik Erlangen
Erlangen, 91054
GermanySite Not Available
Universitaetsklinikum Frankfurt
Frankfurt, 60590
GermanySite Not Available
Universitaetsmedizin Greifswald
Greifswald, 17475
GermanySite Not Available
Evangelisches Krankenhaus Alsterdorf gGmbH
Hamburg, 22337
GermanySite Not Available
Diakonie Kork - Epilepsiezentrum
Kehl-Kork, 77694
GermanySite Not Available
Universitaetsklinikum Giessen und Marburg GmbH
Marburg, 35043
GermanySite Not Available
Klinikum Großhadern der Ludwig-Maximilians-Universität
München, 81377
GermanySite Not Available
Chungnam National University Hospital
Daejeon, 35015
Korea, Republic ofSite Not Available
Asan Medical Center
Seoul, 05505
Korea, Republic ofSite Not Available
Konkuk University Medical Center
Seoul, 05030
Korea, Republic ofSite Not Available
Samsung Medical Center
Seoul, 06351
Korea, Republic ofSite Not Available
Seoul National University Hospital
Seoul, 03080
Korea, Republic ofSite Not Available
Severance Hospital Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
Severance Hospital, Yonsei University Health System
Seoul, 03722
Korea, Republic ofSite Not Available
Centrum Medyczne Neuromed Sp z o. o.
Bydgoszcz, 85-163
PolandSite Not Available
Copernicus Podmiot Leczniczy Sp. z o.o
Gdansk, 80-803
PolandSite Not Available
Centrum Terapii SM
Katowice, 40-571
PolandSite Not Available
MA LEK AM Maciejowscy Spolka Cywilna Centrum Terapii SM
Katowice, 40 571
PolandSite Not Available
NEURO MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna
Katowice, 40 686
PolandSite Not Available
NEURO-MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna
Katowice, 40-686
PolandSite Not Available
NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'
Katowice, 40-123
PolandSite Not Available
Centrum Leczenia Padaczki i Migreny NZOZ
Krakow, 31 209
PolandSite Not Available
Specjalistyczne Gabinety Lekarskie
Krakow, 31 156
PolandSite Not Available
Centrum Leczenia Padaczki i Migreny. NZOZ
Kraków, 31-209
PolandSite Not Available
Centrum Opieki Zdrowotnej Orkan Med Stec Michalska sj
Ksawerow, 95 054
PolandSite Not Available
Centrum Opieki Zdrowotnej Orkan-med Stec-Michalska sj
Ksawerów, 95-054
PolandSite Not Available
Clinical Best Solutions Sp. z o.o., Sp. K.
Lublin, 20-078
PolandSite Not Available
Twoja Przychodnia - Centrum Medyczne Nowa Sol
Nowa Sol, 67-100
PolandSite Not Available
Clinical Research Center sp z o o MEDIC R s k
Poznan, 61 731
PolandSite Not Available
Clinical Research Center sp. z o.o MEDIC-R s.k.
Poznan, 61-731
PolandSite Not Available
NZOZ NEURO KARD Ilkowski i Partnerzy Sp Partnerska Lekarzy
Poznan, 61 853
PolandSite Not Available
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partnerska Lekarzy
Poznan, 61-853
PolandSite Not Available
Clinical Research Center sp. z o.o MEDIC-R s.k.
Poznań, 60-848
PolandSite Not Available
Institute of Psychiatry and Neurology
Warszawa, 02-957
PolandSite Not Available
MTZ Clinical Research Powered by Pratia
Warszawa, 02-172
PolandSite Not Available
Neurosphera
Warszawa, 02-952
PolandSite Not Available
Centrum Medyczne Oporow
Wroclaw, 52 416
PolandSite Not Available
Centrum Medyczne Oporow
Wrocław, 52 416
PolandSite Not Available
ProNeuro Centrum Medyczne
Zory, 44-240
PolandSite Not Available
Republic Clinical Hospital
Kazan, 420064
Russian FederationSite Not Available
Research Medical Center Your Health
Kazan, 420097
Russian FederationSite Not Available
Specialized clinical psychiatric hospital #1
Krasnodar, 350007
Russian FederationSite Not Available
Clinical City Hospital #1
Moscow, 119049
Russian FederationSite Not Available
Nizny Novgorod clinical psychiatric hospital 1
Nizny Novgorod, 603155
Russian FederationSite Not Available
SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky
Saratov, 410028
Russian FederationSite Not Available
Smolensk Regional Clinical Hospital
Smolensk, 214018
Russian FederationSite Not Available
Psychoneurological Dispensary of Frunzensky District
St-Petersburg, 190013
Russian FederationSite Not Available
St-Petersburg Bekhterev Psychoneurological Research Institute
St-Petersburg, 192109
Russian FederationSite Not Available
Yaroslavl State Medical University
Yaroslavl, 150000
Russian FederationSite Not Available
Hosp Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hosp Univ Vall D Hebron
Barcelona, 08035
SpainSite Not Available
Hosp. Clinic I Provincial de Barcelona
Barcelona, 08036
SpainActive - Recruiting
Hosp. Clinic de Barcelona
Barcelona, 08036
SpainSite Not Available
Hosp. Del Mar
Barcelona, 08003
SpainSite Not Available
Hosp. Univ. Vall D Hebron
Barcelona, 08035
SpainSite Not Available
Hosp. de La Santa Creu I Sant Pau
Barcelona, 08041
SpainSite Not Available
Hosp. de la Santa Creu i Sant Pau
Barcelona, 08041
SpainActive - Recruiting
Hosp. Univ. de La Princesa
Madrid, 28006
SpainSite Not Available
Hosp Regional Univ de Malaga
Malaga, 29010
SpainSite Not Available
Hosp. Regional Univ. de Malaga
Malaga, 29010
SpainSite Not Available
Hosp. Regional Univ. de Malaga
Málaga, 29010
SpainSite Not Available
Centro Neurologia Avanzada Sevilla
Sevilla, 41013
SpainSite Not Available
Hosp. Mutua Terrassa
Terrassa, 08222
SpainSite Not Available
Centro de Inv. Avanzada Neurociencias
Zaragoza, 50001
SpainSite Not Available
Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
Dnipro, 49005
UkraineSite Not Available
Medical Center of Private Enterprise Neuron
Kharkiv, 61091
UkraineSite Not Available
Cnce 'Kyiv City Psychoneurological Hospital #2' of Executive Body of Kyiv City Council (Kcsa)
Kyiv, 02192
UkraineSite Not Available
Cnce of Lviv Regional Council 'Lviv Regional Clinical Hospital'
Lviv, 79010
UkraineSite Not Available
Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'
Nove Settlement, 25491
UkraineSite Not Available
Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'
Nove Settlement, Kropyvnytskyi, 25491
UkraineSite Not Available
Mnce 'Ternopil Regional Clinical Psychoneurology Hospital' of Trb
Ternopil, 46027
UkraineSite Not Available
Llc Diamed Medical Center
Uzhhorod, 88000
UkraineSite Not Available
Cnpe 'Vinnytsia Regional Clinical Psycho-Neurological Hospital N.A. Ac. O.I. Yushchenko' of Vrc
Vinnytsya, 21037
UkraineSite Not Available
Tucson Neuroscience Research
Tucson, Arizona 85710
United StatesSite Not Available
Accel Research Sites
DeLand, Florida 32720
United StatesSite Not Available
University of Miami
Miami, Florida 33136
United StatesSite Not Available
Research Institution of Orlando, LLC
Orlando, Florida 32806
United StatesSite Not Available
Accel Research Sites
Port Orange, Florida 32127
United StatesSite Not Available
Emory University School of Medicine
Atlanta, Georgia 30307
United StatesSite Not Available
Ascension Medical Group
Wichita, Kansas 67214
United StatesSite Not Available
Maine Medical Center
Scarborough, Maine 04074
United StatesSite Not Available
John Hopkins Hospital
Baltimore, Maryland 21287
United StatesSite Not Available
Mid-Atlantic Epilepsy and Sleep Center
Bethesda, Maryland 20817
United StatesSite Not Available
Clinical Research Professionals
Chesterfield, Missouri 63005
United StatesSite Not Available
Thomas Jefferson University Hospital
Philadelphia, Pennsylvania 19107
United StatesSite Not Available
Vanderbilt University Medical Center
Nashville, Tennessee 37212
United StatesSite Not Available
University of Virginia
Charlottesville, Virginia 22903
United StatesSite Not Available
Not the study for you?
Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.