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

Primary Purpose

Focal Onset Seizures

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
JNJ-40411813
Placebo
Sponsored by
Janssen Research & Development, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focal Onset Seizures

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Arm Type

Experimental

Placebo Comparator

Arm Label

JNJ-40411813

Placebo

Arm Description

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.

Outcomes

Primary Outcome Measures

Time to Baseline Monthly Seizure Count up to the end of the 12-week Double-blind Treatment Period
Time to baseline monthly seizure count is defined, for each participant, as the number of days until the participants experienced the number of seizures equal to baseline monthly seizure count, up to the end of the 12-week double-blind treatment period. Baseline monthly seizure count will be defined as the number of observable focal onset seizures recorded during the baseline period, multiplied by 28/ XBL, where XBL is the number of days comprising the baseline.
Open Label Extension (OLE) Period: Seizure Count
Seizure count will be reported. Seizure count per 28 days will be calculated as (28/the number of days between visits)*(seizures counted between the visits).
OLE Period: Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
OLE Period: Number of Participants with Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in vital signs including blood pressure and oral or tympanic temperature will be reported.
OLE Period: Number of Participants with Clinically Significant Changes in Laboratory Assessments
Number of participants with clinically significant changes in laboratory assessments including hematology, serum chemistry, serology, and urinalysis will be reported.

Secondary Outcome Measures

Double Blind Treatment Period: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
Double Blind Treatment Period: Number of Participants with Clinically Significant Changes in Laboratory Results
Number of participants with clinically significant changes in laboratory results related to hematology, serum chemistry, serology, and urinalysis will be reported.
Double Blind Treatment Period: Number of Participants with Clinically Significant Changes in Vital Signs
Number of participants with clinically significant changes in vital signs including blood pressure and oral or tympanic temperature will be reported.
Double Blind Treatment Period: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results
Number of participants with clinically significant changes in ECG results will be reported.
Double Blind Treatment Period: Percent reduction in the Double-blind Monthly Seizure Count
Percent reduction in the double-blind monthly seizure count is defined as the double-blind monthly seizure count minus the baseline monthly seizure count, divided by the baseline monthly seizure count. The double-blind monthly seizure count is defined as the total number of observable focal onset seizures occurring during the 12-week double blind treatment period, multiplied by 28/XDB, where XDB is the number of days comprising the double-blind period. Observable seizures that will be counted during baseline and throughout the study include focal aware seizures with motor signs, focal impaired awareness seizures and focal to bilateral tonic-clonic seizures. Focal aware seizures without motor signs, myoclonic, or other generalized seizures will not be counted.
Double Blind Treatment Period: Percentage of Participants with no Seizures During Double-blind Period and who Achieve a More than (>) 50 Percent (%) Reduction in Monthly Seizure Count Relative to Baseline Monthly Seizure Count
Percentage of participants with no seizures during double-blind period and who achieve a > 50% reduction in monthly seizure count relative to baseline monthly seizure count will be reported.
Double Blind Treatment Period: Plasma Concentration of JNJ-40411813
Plasma samples will be analyzed to determine concentration of JNJ-40411813 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC -MS/MS) methods.
Double Blind Treatment Period: Plasma Concentration of Levetiracetam or Brivaracetam
Plasma samples will be analyzed to determine concentration of levetiracetam or brivaracetam using a validated, specific, and sensitive LC -MS/MS methods.
OLE Period: Plasma Concentration of JNJ-40411813
Plasma samples will be analyzed to determine concentration of JNJ-40411813 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC -MS/MS) methods.
OLE Period: Plasma Concentration of Anti-epileptic Drugs (AEDs)
Plasma samples will be analyzed to determine concentration of AEDs using a validated, specific, and sensitive LC-MS/MS methods.
OLE Period: Plasma Concentration of Levetiracetam or Brivaracetam
Plasma samples will be analyzed to determine concentration of levetiracetam or brivaracetam using a validated, specific, and sensitive LC MS/MS methods.

Full Information

First Posted
March 24, 2021
Last Updated
October 10, 2023
Sponsor
Janssen Research & Development, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT04836559
Brief Title
A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
May 18, 2021 (Actual)
Primary Completion Date
April 1, 2024 (Anticipated)
Study Completion Date
April 15, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Janssen Research & Development, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief Summary
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).
Detailed Description
JNJ-40411813 is a positive allosteric modulator (PAM) of the metabotropic glutamate receptor-2 (mGlu2), which is abundantly expressed in the forebrain and cerebellum. The mGlu2 receptor functions as a presynaptic auto-receptor that, upon activation, decreases the release of the excitatory neurotransmitter glutamate. Positive allosteric modulation of a receptor will result in the direct enhancement of the agonist-induced signal while PAMs themselves have generally no or low intrinsic activity at the receptor. The net effect of JNJ-40411813 is hypothesized to be a normalization of hyper-glutamatergic transmission. JNJ-40411813 is being evaluated for the treatment of disorders of the central nervous systems (CNS), such as epilepsy, and has been evaluated in schizophrenia and anxious depression. This study will consist of 1 to a maximum of 3 cohorts. In each cohort, for each participant the study consists of a screening period (up to minus [-] 8 weeks), an 8-week prospective pretreatment baseline period, an up to 12-week double-blind treatment period and a 2-year OLE period or a follow-up telephone visit 2 weeks after the last dose of study intervention. Safety assessments including physical and neurological examination, vital signs, 12 lead electrocardiogram (ECG), clinical chemistry, hematology, and urinalysis will be performed. The total maximal duration of the study is up to 2 years and 5 months.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Onset Seizures

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
160 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
JNJ-40411813
Arm Type
Experimental
Arm Description
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.
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
JNJ-40411813
Intervention Description
JNJ-40411813 will be administered orally.
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo will be administered orally.
Primary Outcome Measure Information:
Title
Time to Baseline Monthly Seizure Count up to the end of the 12-week Double-blind Treatment Period
Description
Time to baseline monthly seizure count is defined, for each participant, as the number of days until the participants experienced the number of seizures equal to baseline monthly seizure count, up to the end of the 12-week double-blind treatment period. Baseline monthly seizure count will be defined as the number of observable focal onset seizures recorded during the baseline period, multiplied by 28/ XBL, where XBL is the number of days comprising the baseline.
Time Frame
Baseline to 12 weeks
Title
Open Label Extension (OLE) Period: Seizure Count
Description
Seizure count will be reported. Seizure count per 28 days will be calculated as (28/the number of days between visits)*(seizures counted between the visits).
Time Frame
Up to 2 years in OLE period
Title
OLE Period: Number of Participants with Adverse Events (AEs)
Description
An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
Time Frame
Up to 2 years in OLE period
Title
OLE Period: Number of Participants with Clinically Significant Changes in Vital Signs
Description
Number of participants with clinically significant changes in vital signs including blood pressure and oral or tympanic temperature will be reported.
Time Frame
Up to 2 years in OLE period
Title
OLE Period: Number of Participants with Clinically Significant Changes in Laboratory Assessments
Description
Number of participants with clinically significant changes in laboratory assessments including hematology, serum chemistry, serology, and urinalysis will be reported.
Time Frame
Up to 2 years in OLE period
Secondary Outcome Measure Information:
Title
Double Blind Treatment Period: Number of Participants with Adverse Events (AEs) as a Measure of Safety and Tolerability
Description
An AE is any untoward medical occurrence in a clinical study participant administered an investigational or non-investigational medicinal product. An AE does not necessarily have a causal relationship with the treatment.
Time Frame
Up to 22 weeks
Title
Double Blind Treatment Period: Number of Participants with Clinically Significant Changes in Laboratory Results
Description
Number of participants with clinically significant changes in laboratory results related to hematology, serum chemistry, serology, and urinalysis will be reported.
Time Frame
Up to 12 weeks
Title
Double Blind Treatment Period: Number of Participants with Clinically Significant Changes in Vital Signs
Description
Number of participants with clinically significant changes in vital signs including blood pressure and oral or tympanic temperature will be reported.
Time Frame
Up to 12 weeks
Title
Double Blind Treatment Period: Number of Participants with Clinically Significant Changes in Electrocardiogram (ECG) Results
Description
Number of participants with clinically significant changes in ECG results will be reported.
Time Frame
Up to 12 weeks
Title
Double Blind Treatment Period: Percent reduction in the Double-blind Monthly Seizure Count
Description
Percent reduction in the double-blind monthly seizure count is defined as the double-blind monthly seizure count minus the baseline monthly seizure count, divided by the baseline monthly seizure count. The double-blind monthly seizure count is defined as the total number of observable focal onset seizures occurring during the 12-week double blind treatment period, multiplied by 28/XDB, where XDB is the number of days comprising the double-blind period. Observable seizures that will be counted during baseline and throughout the study include focal aware seizures with motor signs, focal impaired awareness seizures and focal to bilateral tonic-clonic seizures. Focal aware seizures without motor signs, myoclonic, or other generalized seizures will not be counted.
Time Frame
Baseline, up to 12 weeks
Title
Double Blind Treatment Period: Percentage of Participants with no Seizures During Double-blind Period and who Achieve a More than (>) 50 Percent (%) Reduction in Monthly Seizure Count Relative to Baseline Monthly Seizure Count
Description
Percentage of participants with no seizures during double-blind period and who achieve a > 50% reduction in monthly seizure count relative to baseline monthly seizure count will be reported.
Time Frame
Baseline, up to 12 weeks
Title
Double Blind Treatment Period: Plasma Concentration of JNJ-40411813
Description
Plasma samples will be analyzed to determine concentration of JNJ-40411813 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC -MS/MS) methods.
Time Frame
Baseline (Day 1), Weeks 4, 8, and 12
Title
Double Blind Treatment Period: Plasma Concentration of Levetiracetam or Brivaracetam
Description
Plasma samples will be analyzed to determine concentration of levetiracetam or brivaracetam using a validated, specific, and sensitive LC -MS/MS methods.
Time Frame
Baseline (Day 1), Weeks 4, 8, and 12
Title
OLE Period: Plasma Concentration of JNJ-40411813
Description
Plasma samples will be analyzed to determine concentration of JNJ-40411813 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC -MS/MS) methods.
Time Frame
Up to 1 year in OLE period
Title
OLE Period: Plasma Concentration of Anti-epileptic Drugs (AEDs)
Description
Plasma samples will be analyzed to determine concentration of AEDs using a validated, specific, and sensitive LC-MS/MS methods.
Time Frame
Up to 1 year in OLE period
Title
OLE Period: Plasma Concentration of Levetiracetam or Brivaracetam
Description
Plasma samples will be analyzed to determine concentration of levetiracetam or brivaracetam using a validated, specific, and sensitive LC MS/MS methods.
Time Frame
Up to 1 year in OLE period

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Study Contact
Phone
844-434-4210
Email
Participate-In-This-Study@its.jnj.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Janssen Research & Development, LLC Clinical Trial
Organizational Affiliation
Janssen Research & Development, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Tucson Neuroscience Research
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Individual Site Status
Completed
Facility Name
Research Institution of Orlando, LLC
City
Orlando
State/Province
Florida
ZIP/Postal Code
32806
Country
United States
Individual Site Status
Completed
Facility Name
Accel Research Sites
City
Port Orange
State/Province
Florida
ZIP/Postal Code
32127
Country
United States
Individual Site Status
Completed
Facility Name
Maine Medical Center
City
Scarborough
State/Province
Maine
ZIP/Postal Code
04074
Country
United States
Individual Site Status
Recruiting
Facility Name
Mid-Atlantic Epilepsy and Sleep Center
City
Bethesda
State/Province
Maryland
ZIP/Postal Code
20817
Country
United States
Individual Site Status
Recruiting
Facility Name
Thomas Jefferson University Hospital
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19107
Country
United States
Individual Site Status
Recruiting
Facility Name
University of Virginia
City
Charlottesville
State/Province
Virginia
ZIP/Postal Code
22903
Country
United States
Individual Site Status
Completed
Facility Name
AZ Sint-Jan
City
Brugge
ZIP/Postal Code
8000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Cliniques Universitaires Saint-Luc
City
Bruxelles
ZIP/Postal Code
1200
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Antwerpen
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Az Groeninge
City
Kortrijk
ZIP/Postal Code
8500
Country
Belgium
Individual Site Status
Recruiting
Facility Name
UZ Leuven
City
Leuven
ZIP/Postal Code
B-3000
Country
Belgium
Individual Site Status
Recruiting
Facility Name
CHU UCL Namur - Site Godinne
City
Yvoir
ZIP/Postal Code
5530
Country
Belgium
Individual Site Status
Recruiting
Facility Name
Vivantes Humboldt Klinikum
City
Berlin
ZIP/Postal Code
13509
Country
Germany
Individual Site Status
Completed
Facility Name
Krankenhaus Mara - Bethel
City
Bielefeld
ZIP/Postal Code
33617
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitatsklinikum Bonn
City
Bonn
ZIP/Postal Code
53127
Country
Germany
Individual Site Status
Completed
Facility Name
Universitaetsklinik Erlangen
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Individual Site Status
Completed
Facility Name
Universitaetsklinikum Frankfurt
City
Frankfurt
ZIP/Postal Code
60590
Country
Germany
Individual Site Status
Completed
Facility Name
Diakonie Kork - Epilepsiezentrum
City
Kehl-Kork
ZIP/Postal Code
77694
Country
Germany
Individual Site Status
Recruiting
Facility Name
Universitaetsklinikum Giessen und Marburg GmbH
City
Marburg
ZIP/Postal Code
35043
Country
Germany
Individual Site Status
Recruiting
Facility Name
Chungnam National University Hospital
City
Daejeon
ZIP/Postal Code
35015
Country
Korea, Republic of
Individual Site Status
Completed
Facility Name
Seoul National University Hospital
City
Seoul
ZIP/Postal Code
03080
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Severance Hospital, Yonsei University Health System
City
Seoul
ZIP/Postal Code
03722
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Konkuk University Medical Center
City
Seoul
ZIP/Postal Code
05030
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Asan Medical Center
City
Seoul
ZIP/Postal Code
05505
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Samsung Medical Center
City
Seoul
ZIP/Postal Code
06351
Country
Korea, Republic of
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Neuromed Sp z o. o.
City
Bydgoszcz
ZIP/Postal Code
85-163
Country
Poland
Individual Site Status
Recruiting
Facility Name
Copernicus Podmiot Leczniczy Sp. z o.o
City
Gdansk
ZIP/Postal Code
80-803
Country
Poland
Individual Site Status
Recruiting
Facility Name
NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis'
City
Katowice
ZIP/Postal Code
40-123
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Terapii SM
City
Katowice
ZIP/Postal Code
40-571
Country
Poland
Individual Site Status
Recruiting
Facility Name
NEURO-MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna
City
Katowice
ZIP/Postal Code
40-686
Country
Poland
Individual Site Status
Recruiting
Facility Name
Specjalistyczne Gabinety Lekarskie
City
Krakow
ZIP/Postal Code
31-156
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Leczenia Padaczki i Migreny. NZOZ
City
Kraków
ZIP/Postal Code
31-209
Country
Poland
Individual Site Status
Completed
Facility Name
Centrum Opieki Zdrowotnej Orkan-med Stec-Michalska sj
City
Ksawerów
ZIP/Postal Code
95-054
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Best Solutions Sp. z o.o., Sp. K.
City
Lublin
ZIP/Postal Code
20-078
Country
Poland
Individual Site Status
Recruiting
Facility Name
Twoja Przychodnia - Centrum Medyczne Nowa Sol
City
Nowa Sol
ZIP/Postal Code
67-100
Country
Poland
Individual Site Status
Recruiting
Facility Name
Clinical Research Center sp. z o.o MEDIC-R s.k.
City
Poznan
ZIP/Postal Code
61-731
Country
Poland
Individual Site Status
Completed
Facility Name
NZOZ NEURO-KARD Ilkowski i Partnerzy Sp. Partnerska Lekarzy
City
Poznan
ZIP/Postal Code
61-853
Country
Poland
Individual Site Status
Recruiting
Facility Name
MTZ Clinical Research Powered by Pratia
City
Warszawa
ZIP/Postal Code
02-172
Country
Poland
Individual Site Status
Recruiting
Facility Name
Neurosphera
City
Warszawa
ZIP/Postal Code
02-952
Country
Poland
Individual Site Status
Recruiting
Facility Name
Institute of Psychiatry and Neurology
City
Warszawa
ZIP/Postal Code
02-957
Country
Poland
Individual Site Status
Recruiting
Facility Name
Centrum Medyczne Oporow
City
Wrocław
ZIP/Postal Code
52-416
Country
Poland
Individual Site Status
Recruiting
Facility Name
ProNeuro Centrum Medyczne
City
Zory
ZIP/Postal Code
44-240
Country
Poland
Individual Site Status
Recruiting
Facility Name
Republic Clinical Hospital
City
Kazan
ZIP/Postal Code
420064
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Research Medical Center Your Health
City
Kazan
ZIP/Postal Code
420097
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Specialized clinical psychiatric hospital #1
City
Krasnodar
ZIP/Postal Code
350007
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Clinical City Hospital #1
City
Moscow
ZIP/Postal Code
119049
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Nizny Novgorod clinical psychiatric hospital 1
City
Nizny Novgorod
ZIP/Postal Code
603155
Country
Russian Federation
Individual Site Status
Completed
Facility Name
SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky
City
Saratov
ZIP/Postal Code
410028
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Smolensk Regional Clinical Hospital
City
Smolensk
ZIP/Postal Code
214018
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Psychoneurological Dispensary of Frunzensky District
City
St-Petersburg
ZIP/Postal Code
190013
Country
Russian Federation
Individual Site Status
Completed
Facility Name
St-Petersburg Bekhterev Psychoneurological Research Institute
City
St-Petersburg
ZIP/Postal Code
192109
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Yaroslavl State Medical University
City
Yaroslavl
ZIP/Postal Code
150000
Country
Russian Federation
Individual Site Status
Completed
Facility Name
Hosp. Del Mar
City
Barcelona
ZIP/Postal Code
08003
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. Vall D Hebron
City
Barcelona
ZIP/Postal Code
08035
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Clinic I Provincial de Barcelona
City
Barcelona
ZIP/Postal Code
08036
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. de La Santa Creu I Sant Pau
City
Barcelona
ZIP/Postal Code
08041
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Univ. de La Princesa
City
Madrid
ZIP/Postal Code
28006
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Regional Univ. de Malaga
City
Malaga
ZIP/Postal Code
29010
Country
Spain
Individual Site Status
Recruiting
Facility Name
Centro Neurologia Avanzada Sevilla
City
Sevilla
ZIP/Postal Code
41013
Country
Spain
Individual Site Status
Recruiting
Facility Name
Hosp. Mutua Terrassa
City
Terrassa
ZIP/Postal Code
08222
Country
Spain
Individual Site Status
Recruiting
Facility Name
Centro de Inv. Avanzada Neurociencias
City
Zaragoza
ZIP/Postal Code
50001
Country
Spain
Individual Site Status
Recruiting
Facility Name
Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc
City
Dnipro
ZIP/Postal Code
49005
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Medical Center of Private Enterprise Neuron
City
Kharkiv
ZIP/Postal Code
61091
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Cnce of Lviv Regional Council 'Lviv Regional Clinical Hospital'
City
Lviv
ZIP/Postal Code
79010
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council'
City
Nove Settlement, Kropyvnytskyi
ZIP/Postal Code
25491
Country
Ukraine
Individual Site Status
Completed
Facility Name
Mnce 'Ternopil Regional Clinical Psychoneurology Hospital' of Trb
City
Ternopil
ZIP/Postal Code
46027
Country
Ukraine
Individual Site Status
Terminated
Facility Name
Llc Diamed Medical Center
City
Uzhhorod
ZIP/Postal Code
88000
Country
Ukraine
Individual Site Status
Completed
Facility Name
Cnpe 'Vinnytsia Regional Clinical Psycho-Neurological Hospital N.A. Ac. O.I. Yushchenko' of Vrc
City
Vinnytsya
ZIP/Postal Code
21037
Country
Ukraine
Individual Site Status
Completed

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
The data sharing policy of the Janssen Pharmaceutical Companies of Johnson & Johnson is available at www.janssen.com/clinicaltrials/ transparency. As noted on this site, requests for access to the study data can be submitted through Yale Open Data Access (YODA) Project site at yoda.yale.edu
IPD Sharing URL
https://www.janssen.com/clinical-trials/transparency

Learn more about this trial

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

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