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
Sites (69)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| AZ Sint Jan Coordinator of this site? Confirm its status | Bruges | Belgium | Unknown status |
| Cliniques universitaires Saint-Luc Coordinator of this site? Confirm its status | Brussels | Belgium | Unknown status |
| UZ Antwerpen Coordinator of this site? Confirm its status | Edegem | Belgium | Unknown status |
| AZ Groeninge Coordinator of this site? Confirm its status | Kortrijk | Belgium | Unknown status |
| UZ Leuven Coordinator of this site? Confirm its status | Leuven | Belgium | Unknown status |
| CHU UCL Namur - Site Godinne Coordinator of this site? Confirm its status | Yvoir | Belgium | Unknown status |
| Vivantes Humboldt-Klinikum Coordinator of this site? Confirm its status | Berlin | Germany | Unknown status |
| Krankenhaus Mara - Bethel Coordinator of this site? Confirm its status | Bielefeld | Germany | Unknown status |
| Universitätsklinikum Bonn Coordinator of this site? Confirm its status | Bonn | Germany | Unknown status |
| Universitaetsklinik Erlangen Coordinator of this site? Confirm its status | Erlangen | Germany | Unknown status |
| Universitaetsklinikum Frankfurt Coordinator of this site? Confirm its status | Frankfurt | Germany | Unknown status |
| Diakonie Kork - Epilepsiezentrum Coordinator of this site? Confirm its status | Kehl-Kork | Germany | Unknown status |
| Universitaetsklinikum Giessen und Marburg GmbH Coordinator of this site? Confirm its status | Marburg | Germany | Unknown status |
| Hosp. Del Mar Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp Clinic de Barcelona Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. de La Santa Creu I Sant Pau Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp Univ Vall D Hebron Coordinator of this site? Confirm its status | Barcelona | Spain | Unknown status |
| Hosp. Univ. de La Princesa Coordinator of this site? Confirm its status | Madrid | Spain | Unknown status |
| Hosp Regional Univ de Malaga Coordinator of this site? Confirm its status | Málaga | Spain | Unknown status |
| Centro Neurologia Avanzada Sevilla Coordinator of this site? Confirm its status | Seville | Spain | Unknown status |
| Hosp. Mutua Terrassa Coordinator of this site? Confirm its status | Terrassa | Spain | Unknown status |
| Centro de Inv. Avanzada Neurociencias Coordinator of this site? Confirm its status | Zaragoza | Spain | Unknown status |
| Chungnam National University Hospital Coordinator of this site? Confirm its status | Daejeon | South Korea | Unknown status |
| Asan Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Seoul National University Hospital Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Konkuk University Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Severance Hospital, Yonsei University Health System Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Samsung Medical Center Coordinator of this site? Confirm its status | Seoul | South Korea | Unknown status |
| Centrum Medyczne Neuromed Sp. z.o.o. Coordinator of this site? Confirm its status | Bydgoszcz | Poland | Unknown status |
| Copernicus Podmiot Leczniczy Sp. z o.o Coordinator of this site? Confirm its status | Gdansk | Poland | Unknown status |
| NEURO MEDIC Janusz Zbrojkiewicz Poradnia Wielospecjalistyczna Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| MA LEK AM Maciejowscy Spolka Cywilna Centrum Terapii SM Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| NZOZ Wielospecjalistyczna Poradnia Lekarska "Synapsis" Coordinator of this site? Confirm its status | Katowice | Poland | Unknown status |
| Specjalistyczne Gabinety Lekarskie Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Centrum Leczenia Padaczki i Migreny NZOZ Coordinator of this site? Confirm its status | Krakow | Poland | Unknown status |
| Centrum Opieki Zdrowotnej Orkan Med Stec Michalska sj Coordinator of this site? Confirm its status | Ksawerów | Poland | Unknown status |
| Clinical Best Solutions Sp. z o.o., Sp. K. Coordinator of this site? Confirm its status | Lublin | Poland | Unknown status |
| Twoja Przychodnia Centrum Medyczne Nowa Sól Coordinator of this site? Confirm its status | Nowa Sól | Poland | Unknown status |
| NZOZ NEURO KARD Ilkowski i Partnerzy Sp Partnerska Lekarzy Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| Clinical Research Center sp z o o MEDIC R s k Coordinator of this site? Confirm its status | Poznan | Poland | Unknown status |
| MTZ Clinical Research powered by Pratia Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Institute of Psychiatry and Neurology Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Neurosphera Coordinator of this site? Confirm its status | Warsaw | Poland | Unknown status |
| Centrum Medyczne Oporow Coordinator of this site? Confirm its status | Wroclaw | Poland | Unknown status |
| ProNeuro Centrum Medyczne Coordinator of this site? Confirm its status | Zory | Poland | Unknown status |
| Research Medical Center Your Health Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
| Republic Clinical Hospital Coordinator of this site? Confirm its status | Kazan' | Russia | Unknown status |
| Specialized clinical psychiatric hospital #1 Coordinator of this site? Confirm its status | Krasnodar | Russia | Unknown status |
| Clinical City Hospital #1 Coordinator of this site? Confirm its status | Moscow | Russia | Unknown status |
| Nizny Novgorod clinical psychiatric hospital 1 Coordinator of this site? Confirm its status | Nizny Novgorod | Russia | Unknown status |
| St-Petersburg Bekhterev Psychoneurological Research Institute Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| Psychoneurological Dispensary of Frunzensky District Coordinator of this site? Confirm its status | Saint Petersburg | Russia | Unknown status |
| SHI 'Saratov City Clinical Hospital 2 n.a V.I. Razumovsky Coordinator of this site? Confirm its status | Saratov | Russia | Unknown status |
| Smolensk Regional Clinical Hospital Coordinator of this site? Confirm its status | Smolensk | Russia | Unknown status |
| Yaroslavl State Medical University Coordinator of this site? Confirm its status | Yaroslavl | Russia | Unknown status |
| Ce 'Dnipropetrovsk Regional Clinical Hospital N.A. Mechnikov' of Dnipropetrovsk Rc Coordinator of this site? Confirm its status | Dnipro | Ukraine | Unknown status |
| Medical Center of Private Enterprise Neuron Coordinator of this site? Confirm its status | Kharkiv | Ukraine | Unknown status |
| Cnce of Lviv Regional Council 'Lviv Regional Clinical Hospital' Coordinator of this site? Confirm its status | Lviv | Ukraine | Unknown status |
| Mnpe 'Regional Clinical Psychiatric Hospital of Kirovohrad Regional Council' Coordinator of this site? Confirm its status | Nove Settlement | Ukraine | Unknown status |
| Mnce 'Ternopil Regional Clinical Psychoneurology Hospital' of Trb Coordinator of this site? Confirm its status | Ternopil | Ukraine | Unknown status |
| Llc Diamed Medical Center Coordinator of this site? Confirm its status | Uzhhorod | Ukraine | Unknown status |
| Cnpe 'Vinnytsia Regional Clinical Psycho-Neurological Hospital N.A. Ac. O.I. Yushchenko' of Vrc Coordinator of this site? Confirm its status | Vinnytsia | Ukraine | Unknown status |
| Mid-Atlantic Epilepsy and Sleep Center Coordinator of this site? Confirm its status | Bethesda | United States | Unknown status |
| University of Virginia Coordinator of this site? Confirm its status | Charlottesville | United States | Unknown status |
| Research Institution of Orlando, LLC Coordinator of this site? Confirm its status | Orlando | United States | Unknown status |
| Thomas Jefferson University Hospital Coordinator of this site? Confirm its status | Philadelphia | United States | Unknown status |
| Accel Research Sites Coordinator of this site? Confirm its status | Port Orange | United States | Unknown status |
| Maine Medical Center Coordinator of this site? Confirm its status | Scarborough | United States | Unknown status |
| Tucson Neuroscience Research Coordinator of this site? Confirm its status | Tucson | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.