A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy
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).
Timeline
- Start
- 2021-05-18
- Primary completion
- 2024-02-08
- Completion
- 2024-02-08
Outcome
Missed primary endpoint
registry analysis (superiority test); DB: Cohort 1: Placebo vs DB: Cohort 1: JNJ-40411813; p = 0.3571 NCT04836559 ↗
registry analysis (superiority test); DB: Cohort 2: Placebo vs DB: Cohort 2: JNJ-40411813; p = 0.6306 NCT04836559 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | JNJ-40411813 | Small molecule | — | Oral |