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NCT04836559 (JNJ-40411813 in Focal Onset Seizures): BVCT ex-ante prediction vs. reported outcome

On 9 Apr 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 29 Apr 2024 readout is classified on the dashboard as True Negative (TN), a correct prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04836559
Drug Name
JNJ-40411813
Drug MoA
mGluR2 PAM
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Focal Onset Seizures
Human Patients
110
Sponsor
Johnson & Johnson / Addex Therapeutics
Phase
Phase 2

Prediction of , index 893

Prospective Prediction
Prediction Index
893
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet very weak additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
20 days in advance
Readout Data Interpretation
primary endpoint not met; development discontinued
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
True Negative (TN)

ClinicalTrials.gov record

ClinicalTrials.gov record, retrieved 2026-09-24. Third-party data.

Official title
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
Phase
Phase 2
Status
Completed
Enrollment
110
Lead sponsor
Janssen Research & Development, LLC
Conditions
Focal Onset Seizures
Interventions
DRUG: JNJ-40411813; DRUG: Placebo
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2021-05-18
Primary completion
2024-02-08
Completion
2024-02-08
Results first posted
2025-07-03
Primary outcomes
  • Cohort 1 and 2: Time to Baseline Monthly Seizure Count up to the End of the 12-week Double-blind (DB) Treatment Period (From DB period Day 1 up to Day 85)

NCT04836559 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

How to read these records: evidence · methodology · all trials