BioinvestGPT ApS · Research use only

NCT05182476 (Luvadaxistat in Schizophrenia): BVCT ex-ante prediction vs. reported outcome

On 30 Nov 2023, BioinvestGPT's BVCT predicted technical partial success and commercial failure for this trial. The 12 Sep 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

Acronym
ERUDITE
Drug Name
Luvadaxistat
Drug MoA
DAAO inhibitor
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Schizophrenia
Human Patients
216
Sponsor
Neurocrine Biosciences
Phase
Phase 2

Prediction of , index 1364

Prospective Prediction
Prediction Index
1364
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
287 days in advance
Readout Data Interpretation
uvadaxistat failed to meet primary endpoint.
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 Study to Evaluate the Efficacy, Safety, and Tolerability of Luvadaxistat in Subjects With Cognitive Impairment Associated With Schizophrenia, Followed by Open-Label Treatment
Phase
Phase 2
Status
Terminated
Enrollment
216
Lead sponsor
Neurocrine Biosciences
Conditions
Schizophrenia
Interventions
DRUG: Placebo; DRUG: Luvadaxistat
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-12-07
Primary completion
2024-06-28
Completion
2024-10-14
Primary outcomes
  • Change From Baseline on the Brief Assessment of Cognition in Schizophrenia (BAC) Composite Score (Baseline, Day 98)

NCT05182476 on ClinicalTrials.gov

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