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NCT04959032 (Lumateperone in Schizophrenia relapse prevention): BVCT ex-ante prediction vs. reported outcome

On 23 Sep 2022, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 5 Nov 2024 readout is classified on the dashboard as True Positive (TP), a correct prediction. Recorded clinical-benefit conclusion: statistically significant and commercially sufficient.

Clinical Trial

NCTID
NCT04959032
Drug Name
Lumateperone
Drug MoA
5HT2AR antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Schizophrenia relapse prevention
Human Patients
228
Sponsor
Intra-Cellular Therapies
Phase
Phase 3

Prediction of , index 357

Prospective Prediction
Prediction Index
357
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient clinical benefit)
Technical Prediction
SUCCESS (statistically significant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
774 days in advance
Readout Data Interpretation
Lumateperone achieved a 22.2% placebo-adjusted lower relapse of schizophrenia (16.4% vs 38.6%; p=0.0002)
Press Release
Prediction Result
Prediction Accuracy
Correct Prediction
Clinical Benefit Conclusion
statistically significant and commercially sufficient
Prediction Classification
True Positive (TP)

ClinicalTrials.gov record

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

Official title
A Randomized, Double-blind, Placebo-controlled, Parallel-group Study of Lumateperone for the Prevention of Relapse in Patients With Schizophrenia
Phase
Phase 3
Status
Completed
Enrollment
228
Lead sponsor
Intra-Cellular Therapies, Inc.
Conditions
Schizophrenia
Interventions
DRUG: Lumateperone 42 mg; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2021-07-08
Primary completion
2024-07-25
Completion
2024-08-07
Primary outcomes
  • Time to first symptom relapse during the Double-blind Treatment Phase (Number of days from the randomization date to the first relapse date up to 26 weeks.)

NCT04959032 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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