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NCT04244175 (Darigabat in Focal Onset Seizures): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2024, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 6 May 2025 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
NCT04244175
Acronym
REALIZE
Drug Name
Darigabat (CVL-865)
Drug MoA
subtype-selective GABAAR PAM
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Focal Onset Seizures
Human Patients
154
Sponsor
AbbVie
Phase
Phase 2

Prediction of , index 1460

Prospective Prediction
Prediction Index
1460
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient additive clinical benefit)
Technical Prediction
partial SUCCESS (statistically maybe significant yet weak additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
447 days in advance
Readout Data Interpretation
Darigabat failed to meet the primary endpoint of response ratio compared with placebo (P>0.8)
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 Trial of CVL-865 as Adjunctive Therapy in Adults With Drug-Resistant Focal Onset Seizures (REALIZE Trial)
Phase
Phase 2
Status
Completed
Enrollment
154
Lead sponsor
AbbVie
Conditions
Seizures
Interventions
DRUG: Placebo; DRUG: CVL-865
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2020-01-27
Primary completion
2024-05-21
Completion
2024-05-21
Results first posted
2025-05-30
Primary outcomes
  • Response Ratio (RRatio) (Baseline Period; Maintenance Phase Days 15 through 71)

NCT04244175 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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