Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
JNJ-40411813 · 4 trials · 5 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.
| 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. |
| 001 | EXPERIMENTAL | JNJ-40411813 500 mg as 20 mL of oral suspension single dose |
| 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 |
| 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. |
| normal saline | DRUG | single dose |
| ketamine | DRUG | 20 mL of oral suspension |
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 developed by Johnson & Johnson for neurological and psychiatric conditions. It has been studied in Phase 2 trials for focal onset seizures, major depressive disorder, and schizophrenia. It is a positive allosteric modulator of the metabotropic glutamate receptor 2 (GRM2).
JNJ-40411813 has been evaluated as a treatment for focal onset seizures, major depressive disorder, and schizophrenia. It has also been studied in perceptual disorders. All clinical trials to date are completed, and the drug remains investigational.
JNJ-40411813 targets GRM2, also known as metabotropic glutamate receptor 2. It acts as a positive allosteric modulator of this receptor. This mechanism is being explored for neurological and psychiatric conditions such as focal onset seizures and schizophrenia.
JNJ-40411813 is developed by Johnson & Johnson, which trades on the New York Stock Exchange under the ticker JNJ. The company has sponsored clinical trials of the drug in epilepsy, depression, and schizophrenia.
JNJ-40411813 is in Phase 2 clinical development. It has completed Phase 2 trials in focal onset seizures, major depressive disorder, and schizophrenia, as well as a Phase 1 ketamine challenge study. It is not approved for any indication.
JNJ-40411813 has been studied in completed trials including NCT04836559 in focal onset seizures, NCT01582815 in major depressive disorder, NCT01323205 in schizophrenia, and NCT01101659, a Phase 1 ketamine challenge study. No trials are currently active.