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NCT04836559CompletedPhase 2

A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy

A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Multicenter Study to Evaluate the Efficacy, Safety, and Tolerability of JNJ-40411813 as Adjunctive Therapy in Subjects With Focal Onset Seizures With Suboptimal Response to Levetiracetam or Brivaracetam

Source: ClinicalTrials.gov · Last updated 3 Jul 2025

Brief summary (registry, in English)

The purpose of this study is to evaluate the efficacy of up to 3 dose levels of adjunctive JNJ-40411813 compared to placebo based on the time to baseline monthly seizure count in participants with focal onset seizures who are receiving levetiracetam or brivaracetam and up to 3 other anti-epileptic drugs (AEDs) (double-blind treatment period) and to evaluate the long-term efficacy and safety of adjunctive therapy with JNJ-40411813 in participants with epilepsy (open-label extension \[OLE\] period).

Status (registry)
Completed
Phase (registry)
Phase 2
Study type
Interventional
Enrollment
110 (actual)
First submitted
24 Mar 2021
Start date
18 May 2021
Primary completion date
8 Feb 2024
Lead sponsor
Janssen Research & Development, LLC
Diseases
Epilepsy
NCT number
NCT04836559
EudraCT number
2020-003698-24

What you commit to

  • Study type: Interventional · Phase 2
  • Participants enrolled: 110
  • From 18 May 2021 to the primary completion date, 8 Feb 2024
  • 69 sites in 8 countries
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Current treatment with vagus nerve stimulation, deep brain and cortical stimulation for 1 year or less
  • Current treatment with vigabatrin

Other illness

  • 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
  • Planned epilepsy surgery within the next 6 months or completed epilepsy surgery less than (\<) 6 months ago
  • 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
  • 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

Other

  • Exacerbation of MDD within the past 6 months; antidepressant use is allowed

Who the study is looking for

  • 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

Age in the registry: 18 years to 69 years · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (69)

Sites in registry order. Pick your city on the disease page to sort them by distance.

SiteCityCountrySite status
AZ Sint Jan
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BrugesBelgiumUnknown status
Cliniques universitaires Saint-Luc
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BrusselsBelgiumUnknown status
UZ Antwerpen
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EdegemBelgiumUnknown status
AZ Groeninge
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KortrijkBelgiumUnknown status
UZ Leuven
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LeuvenBelgiumUnknown status
CHU UCL Namur - Site Godinne
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YvoirBelgiumUnknown status
Vivantes Humboldt-Klinikum
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BerlinGermanyUnknown status
Krankenhaus Mara - Bethel
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BielefeldGermanyUnknown status
Universitätsklinikum Bonn
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BonnGermanyUnknown status
Universitaetsklinik Erlangen
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ErlangenGermanyUnknown status
Universitaetsklinikum Frankfurt
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FrankfurtGermanyUnknown status
Diakonie Kork - Epilepsiezentrum
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Kehl-KorkGermanyUnknown status
Universitaetsklinikum Giessen und Marburg GmbH
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MarburgGermanyUnknown status
Hosp. Del Mar
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BarcelonaSpainUnknown status
Hosp Clinic de Barcelona
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BarcelonaSpainUnknown status
Hosp. de La Santa Creu I Sant Pau
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BarcelonaSpainUnknown status
Hosp Univ Vall D Hebron
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BarcelonaSpainUnknown status
Hosp. Univ. de La Princesa
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MadridSpainUnknown status
Hosp Regional Univ de Malaga
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MálagaSpainUnknown status
Centro Neurologia Avanzada Sevilla
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SevilleSpainUnknown status
Hosp. Mutua Terrassa
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TerrassaSpainUnknown status
Centro de Inv. Avanzada Neurociencias
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ZaragozaSpainUnknown status
Chungnam National University Hospital
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DaejeonSouth KoreaUnknown status
Asan Medical Center
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SeoulSouth KoreaUnknown status
Seoul National University Hospital
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SeoulSouth KoreaUnknown status
Konkuk University Medical Center
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SeoulSouth KoreaUnknown status
Severance Hospital, Yonsei University Health System
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SeoulSouth KoreaUnknown status
Samsung Medical Center
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SeoulSouth KoreaUnknown status
Centrum Medyczne Neuromed Sp. z.o.o.
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BydgoszczPolandUnknown status
Copernicus Podmiot Leczniczy Sp. z o.o
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GdanskPolandUnknown status
NEURO MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna
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KatowicePolandUnknown status
MA LEK AM Maciejowscy Spolka Cywilna Centrum Terapii SM
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KatowicePolandUnknown status
NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis"
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KatowicePolandUnknown status
Specjalistyczne Gabinety Lekarskie
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KrakowPolandUnknown status
Centrum Leczenia Padaczki i Migreny NZOZ
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KrakowPolandUnknown status
Centrum Opieki Zdrowotnej Orkan Med Stec Michalska sj
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KsawerówPolandUnknown status
Clinical Best Solutions Sp. z o.o., Sp. K.
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LublinPolandUnknown status
Twoja Przychodnia Centrum Medyczne Nowa Sól
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Nowa SólPolandUnknown status
NZOZ NEURO KARD Ilkowski i Partnerzy Sp Partnerska Lekarzy
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PoznanPolandUnknown status
Clinical Research Center sp z o o MEDIC R s k
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PoznanPolandUnknown status
MTZ Clinical Research powered by Pratia
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WarsawPolandUnknown status
Institute of Psychiatry and Neurology
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WarsawPolandUnknown status
Neurosphera
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WarsawPolandUnknown status
Centrum Medyczne Oporow
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WroclawPolandUnknown status
ProNeuro Centrum Medyczne
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ZoryPolandUnknown status
Research Medical Center Your Health
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Kazan'RussiaUnknown status
Republic Clinical Hospital
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Kazan'RussiaUnknown status
Specialized clinical psychiatric hospital #1
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KrasnodarRussiaUnknown status
Clinical City Hospital #1
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MoscowRussiaUnknown status
Nizny Novgorod clinical psychiatric hospital 1
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Nizny NovgorodRussiaUnknown status
St-Petersburg Bekhterev Psychoneurological Research Institute
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Saint PetersburgRussiaUnknown status
Psychoneurological Dispensary of Frunzensky District
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Saint PetersburgRussiaUnknown status
SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky
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SaratovRussiaUnknown status
Smolensk Regional Clinical Hospital
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SmolenskRussiaUnknown status
Yaroslavl State Medical University
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YaroslavlRussiaUnknown status
Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
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DniproUkraineUnknown status
Medical Center of Private Enterprise Neuron
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KharkivUkraineUnknown status
Cnce of Lviv Regional Council 'Lviv Regional Clinical Hospital'
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LvivUkraineUnknown status
Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'
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Nove SettlementUkraineUnknown status
Mnce 'Ternopil Regional Clinical Psychoneurology Hospital' of Trb
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TernopilUkraineUnknown status
Llc Diamed Medical Center
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UzhhorodUkraineUnknown status
Cnpe 'Vinnytsia Regional Clinical Psycho-Neurological Hospital N.A. Ac. O.I. Yushchenko' of Vrc
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VinnytsiaUkraineUnknown status
Mid-Atlantic Epilepsy and Sleep Center
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BethesdaUnited StatesUnknown status
University of Virginia
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CharlottesvilleUnited StatesUnknown status
Research Institution of Orlando, LLC
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OrlandoUnited StatesUnknown status
Thomas Jefferson University Hospital
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PhiladelphiaUnited StatesUnknown status
Accel Research Sites
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Port OrangeUnited StatesUnknown status
Maine Medical Center
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ScarboroughUnited StatesUnknown status
Tucson Neuroscience Research
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TucsonUnited StatesUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.