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

Completed · Phase 2 · Has a placebo group

Conditions studied: Focal Onset Seizures

In brief

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).

Key facts

Study ID: NCT04836559
Run by: Janssen Research & Development, LLC
People needed: 110
Starts: 2021-05-18
Expected to finish: 2024-02-08
Last updated by the study team: 2025-07-03

Who can join

Age: 18 and older, up to 69. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

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

You may not qualify if…

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

Where it is running

Research Institution of Orlando, LLC — Orlando, Florida, United States
Accel Research Sites — Port Orange, Florida, United States
Maine Medical Center — Scarborough, Maine, United States
Mid-Atlantic Epilepsy and Sleep Center — Bethesda, Maryland, United States
Thomas Jefferson University Hospital — Philadelphia, Pennsylvania, United States
University of Virginia — Charlottesville, Virginia, United States
AZ Sint-Jan — Bruges, Belgium
Cliniques Universitaires Saint Luc — Brussels, Belgium
UZ Antwerpen — Edegem, Belgium
Az Groeninge — Kortrijk, Belgium
UZ Leuven — Leuven, Belgium
CHU UCL Namur - Site Godinne — Yvoir, Belgium
Vivantes Humboldt Klinikum — Berlin, Germany
Krankenhaus Mara - Bethel — Bielefeld, Germany
Universitatsklinikum Bonn — Bonn, Germany
Universitaetsklinik Erlangen — Erlangen, Germany
Universitaetsklinikum Frankfurt — Frankfurt, Germany
Diakonie Kork - Epilepsiezentrum — Kehl-Kork, Germany
Universitaetsklinikum Giessen und Marburg GmbH — Marburg, Germany
Centrum Medyczne Neuromed Sp z o. o. — Bydgoszcz, Poland
Copernicus Podmiot Leczniczy Sp. z o.o — Gdansk, Poland
MA LEK AM Maciejowscy Spolka Cywilna Centrum Terapii SM — Katowice, Poland
NEURO MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna — Katowice, Poland
NZOZ Wielospecjalistyczna Poradnia Lekarska 'Synapsis' — Katowice, Poland
Tucson Neuroscience Research — Tucson, Arizona, United States

Full record on ClinicalTrials.gov

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