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NCT04836559 · ClinicalTrials.gov registry record · Phase 2
A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy
A Phase 2 study, sponsored by Janssen Research & Development.
- Completed
- Registry status
- Phase 2
- Development phase
- 110
- Enrollment target
NCT04836559: Completed Phase 2 study, sponsored by Janssen Research & Development.
NCT04836559 is a Phase 2 study that has completed, run by Janssen Research & Development. The registered enrollment target is 110 participants, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04836559, a Phase 2 study, has completed, sponsored by Janssen Research & Development.
- COMPLETED
- Registry status
- Phase 2
- Development phase
- 110 participants
- Enrollment target
Study 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).
Primary Outcome
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
Interventions
- DRUG Placebo
- DRUG JNJ-40411813
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 110 participants |
| Start Date | 2021-05-18 |
| Est. Completion | 2024-02-08 |
| Phase | Phase 2 |
What the finished NCT04836559 record still lists
NCT04836559 is an interventional study that assigns participants to a tested intervention. The registered 110 participants enrollment target is mid-sized for trials with a published cap, below the 133-participant average among 30,622 other Phase 2 trials with a reported enrollment target (17% lower).
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT04836559 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT04836559 about?
NCT04836559 is a clinical study titled "A Study to Investigate JNJ-40411813 in Combination With Levetiracetam or Brivaracetam in Epilepsy". 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 d...
What is the current status of trial NCT04836559?
This trial is currently completed. It is a Phase 2 study. The enrollment target is 110 participants. The study started on 2021-05-18. Estimated completion is 2024-02-08.
What interventions are being tested in trial NCT04836559?
The interventions under investigation include: Placebo (DRUG), JNJ-40411813 (DRUG).
Who is sponsoring clinical trial NCT04836559?
This trial is sponsored by Janssen Research & Development, which has 593 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT04836559's enrollment target sits among peer trials
110 632nd of 2000 higher than 1,361 of 2,000 other Phase 2 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 2 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
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