Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-40411813 · 8 trials · 6 indications
Time (in days) to baseline monthly seizure count was defined as the number of days until the participants cumulative seizure count during the DB period was equal to their baseline monthly seizure count. The baseline monthly seizure count was defined as the number of observable focal onset seizures occurred during the 8-week baseline period (Day -56 to -1), multiplied by 28/XBL, where XBL was the number of days comprising the participants baseline period. Observable focal onset seizures included 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 was not counted towards baseline monthly seizure count. Cluster seizures were counted as a single seizure. Kaplan-Meier method was used for the analysis.
The HAM-A6 is a 6-item subscale derived from the original Hamilton Anxiety scale (HAM-A). The rating scale measures the severity of anxiety symptomatology. Higher scores represent more severe anxiety symptoms.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
An AE is any untoward medical occurrence in a participant participating in a clinical study that does not necessarily have a causal relationship with the pharmaceutical/biological agent under study.
Plasma samples will be analyzed to determine concentrations of JNJ-40411813 using a validated, specific, and sensitive liquid chromatography mass spectrometry/mass spectrometry (LC-MS/MS).
Plasma samples will be analyzed to determine concentrations of JNJ-40411813 using a validated, specific, and sensitive LC-MS/MS.
This sample will be used for pharmacokinetics analysis.
This sample will be used for pharmacokinetics analysis.
Time 't' is the time of the last quantifiable concentration of JNJ-40411813. This sample will be used for pharmacokinetics analysis.
This sample will be used for pharmacokinetics analysis.
This sample will be used for pharmacokinetics analysis.
This sample will be used for pharmacokinetics analysis.
This sample will be used for pharmacokinetics analysis.
This sample will be used for pharmacokinetics analysis.
This test will be used for pharmacodynamics analysis. Cognitive test is a group of mental processes that includes attention, memory, producing and understanding language, learning, reasoning, problem solving, and decision making. It is assess by word presentation, immediate word recall, picture presentation, simple reaction time, digit vigilance, choice reaction time, spatial working memory, numeric working memory, delayed word recall, word recognition, and picture recognition. It refers to an information processing view of a participant's psychological functions.
This questionnaire will be used for pharmacodynamics analysis. The ARCI-Q is a 49-item questionnaire that probes subjective feeling induced by a drug and categorizes them in four classes of drugs of abuse (morphine-like opioids, alcohol, stimulants and hallucinogens). This test is a self-rating scale. Only 'True (positive)' responses are scored. One point is given for each true response in items. The final score is the sum of the total 'true' responses. Lower scores indicate worsening.
REM sleep is a normal stage of sleep characterized by the rapid and random movement of the eyes. REM sleep latency is the time from sleep onset until first period of REM sleep. Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep).
Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep). It will be calculated as number of epochs scored as REM sleep divided by 2.
Polysomnographic recordings will be used to determine the time spent in different sleep stages (S1: light sleep, S2: light sleep, S3: deep sleep, and S4: REM sleep). It will be calculated as number of stages score as 3 or stage 4 divided by 2.
| Arm | Type | Description |
|---|---|---|
| JNJ-40411813 | EXPERIMENTAL | 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. |
| Placebo | PLACEBO_COMPARATOR | 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. |
| JNJ-40411813 (Part A) | EXPERIMENTAL | JNJ-40411813 starting dose from 50 to 150 mg according to tolerability dose range increased stepwise from 50 mg to 150 mg capsule by mouth orally. Capsule (s) taken twice daily with a meal for 12 weeks. |
| JNJ-40411813 (Part B) | EXPERIMENTAL | JNJ-40411813 starting dose from 50 to 150 mg according to tolerability dose range increased stepwise from 50 mg to 150 mg capsule by mouth orally. Capsule (s) taken twice daily with a meal for 10 weeks. |
| Placebo and JNJ-40411813 (Part B) | EXPERIMENTAL | Placebo capsule (s) orally twice daily with a meal for 4 weeks followed by JNJ-40411813 according to tolerability dose range increased from 50 mg to 150 mg twice daily with a meal to 6 weeks. |
| Part 1: JNJ-40411813 or Matching Placebo | EXPERIMENTAL | Participants will receive a single oral dose of JNJ-40411813 or a matching placebo in Cohorts 1, 2, and 3. |
| Part 2: JNJ-40411813 | EXPERIMENTAL | Participants will receive a single oral dose of JNJ-40411813 in Cohort 4. |
| Part 3: JNJ-40411813 or Matching Placebo | EXPERIMENTAL | Participants will receive a multiple oral dose of JNJ-40411813 or a matching placebo in Cohort 5 and optional Cohort 6. |
| 001 | EXPERIMENTAL | JNJ-40411813 Cohort 1: Type=2 to 3 unit=mg number=200 to 300 form=capsule route=oral use.Capsule(s) taken in the fed state Capsule(s) taken in the fed state.,JNJ-40411813 Cohort 2: Type=up to 7 unit=mg number=up to 700 mg form=capsule route=oral use. Capsule(s) taken in the fed state. |
| Cohort 1 | EXPERIMENTAL | - |
| Cohort 2 | EXPERIMENTAL | - |
| 002 | PLACEBO_COMPARATOR | Placebo 20 mL of oral suspension single dose |
| 003 | OTHER | ketamine Ketanest S. vials of 20 ml with 5 mg/ml diluted with saline to 0.02 mg Ketamine per mL and per kg bodyweight of the volunteer |
| 004 | OTHER | normal saline infusion 0.5 mL /min over 90 minutes |
| Sequence 1 | EXPERIMENTAL | Participants will receive the study medications in the sequence of placebo, citalopram, and JNJ-40411813, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days. |
| Sequence 2 | EXPERIMENTAL | Participants will receive the study medications in the sequence of placebo, JNJ-40411813, and citalopram, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days. |
| Sequence 3 | EXPERIMENTAL | Participants will receive the study medications in the sequence of citalopram, placebo, and JNJ-40411813, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days. |
| Sequence 4 | EXPERIMENTAL | Participants will receive the study medications in the sequence of citalopram, JNJ-40411813, and placebo, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days. |
| Sequence 5 | EXPERIMENTAL | Participants will receive the study medications in the sequence of JNJ-40411813, placebo, and citalopram, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days. |
| Sequence 6 | EXPERIMENTAL | Participants will receive the study medications in the sequence of JNJ-40411813, citalopram, and placebo, in 3 treatment periods. Each treatment period has 3 days and subsequent treatment period will be separated by 7 days. |
| Name | Type | Description |
|---|---|---|
| JNJ-40411813 | DRUG | JNJ-40411813 will be administered orally. |
| Placebo | DRUG | Placebo will be administered orally. |
| Antipsychotic medication | DRUG | Regular antipsychotic medications (Risperidone, Olanzapine, Clozapine, Amisulpride, Quetiapine, Paliperidone, Aripiprazole, Haloperidol, Levomepromazine, Zuclopenthixol Hydrochloride, Clotiapine, Pipamperone Hydrochloride, Benperidol, Flupentixol, Fluphenazine Decanoate, Melperone Hydrochloride, or Chlorpromazine Hydrochloride) will be continued in Part B. |
| Matching Placebo | DRUG | Matching placebo will be administered orally. |
| JNJ-40411813 50 mg | DRUG | Cohort 1: Participants will receive 50 mg of JNJ-40411813 (2 capsules X 25 mg) once a day on Day 1 in Period 1 and twice a day on Days 1 to 9 and once a day on Day 10 in Period 2 orally (by mouth). |
| JNJ-40411813 100 mg | DRUG | Cohort 2: Participants will receive 100 mg of JNJ-40411813 (1 capsule X 100 mg) once a day on Day 1 in Period 1 and twice a day on Days 1 to 9 and once a day on Day 10 in Period 2 orally (by mouth). |
| normal saline | DRUG | single dose |
| ketamine | DRUG | 20 mL of oral suspension |
| Citalopram | DRUG | Participants will receive citalopram 20 mg tablet orally once daily on Day 3 in appropriate treatment periods. |
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) ...
JNJ-40411813 is an investigational small molecule being studied for neurological and psychiatric conditions, including focal onset seizures, perceptual disorders, major depressive disorder, and schizophrenia. It has been evaluated in healthy volunteers and in patients with these conditions, but it is not approved and remains in clinical development.
JNJ-40411813 is being developed by Johnson & Johnson, a company traded on the New York Stock Exchange under the ticker JNJ. The drug is an investigational small molecule in Phase 2 clinical development for neurological and psychiatric indications.
JNJ-40411813 is in Phase 2 clinical development. It has completed four clinical trials, including Phase 1 studies in healthy volunteers and a Phase 2 study in patients with focal onset seizures. The drug is investigational and has not been approved by regulatory authorities.
JNJ-40411813 has completed four clinical trials. These include NCT01101659, a ketamine challenge study in perceptual disorders and schizophrenia; NCT01358006 and NCT01951053, Phase 1 studies in healthy volunteers; and NCT04836559, a Phase 2 study in focal onset seizures when combined with levetiracetam or brivaracetam.
JNJ-40411813 and JNJ-404118413 refer to the same investigational drug. The compound has been identified under both names in clinical trial records, including a Phase 1 study titled with the JNJ-404118413 designation. Both names point to the same small molecule being developed by Johnson & Johnson.
Yes, JNJ-40411813 has been studied in epilepsy. A completed Phase 2 trial, NCT04836559, investigated the drug in combination with levetiracetam or brivaracetam in patients with focal onset seizures. The trial enrolled 110 participants across multiple countries, including the United States, Belgium, Germany, Poland, Russia, South Korea, Spain, and Ukraine.