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NCT04531982 (Pimavanserin in Schizophrenia): BVCT ex-ante prediction vs. reported outcome

On 27 Nov 2023, BioinvestGPT's BVCT predicted technical success and commercial success for this trial. The 11 Mar 2024 readout is classified on the dashboard as False Positive (FP), a missed prediction. Recorded clinical-benefit conclusion: statistically insignificant and commercially insufficient.

Clinical Trial

NCTID
NCT04531982
Acronym
ADVANCE-2
Drug Name
Pimavanserin
Drug MoA
5HT2AR/5HT2CR antagonist
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
Schizophrenia
Human Patients
454
Sponsor
Acadia Pharmaceuticals
Phase
Phase 3

Prediction of , index 1346

Prospective Prediction
Prediction Index
1346
Prediction Date
Commercial Prediction
SUCCESS (commercially sufficient additive clinical benefit non-inferior to KarXT)
Technical Prediction
SUCCESS (statistically significant additive clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
105 days in advance
Readout Data Interpretation
primary endpoint not met.
Press Release
Prediction Result
Prediction Accuracy
Missed Prediction
Due to
due to suboptimal modeling of drug MoA that has been permanently corrected.
Clinical Benefit Conclusion
statistically insignificant and commercially insufficient
Prediction Classification
False Positive (FP)

ClinicalTrials.gov record

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

Official title
A Phase 3, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Pimavanserin as Adjunctive Treatment for the Negative Symptoms of Schizophrenia
Phase
Phase 3
Status
Completed
Enrollment
454
Lead sponsor
ACADIA Pharmaceuticals Inc.
Conditions
Schizophrenia
Interventions
DRUG: Pimavanserin; DRUG: Placebo
Design
Randomized · Parallel · Quadruple
Primary purpose
Treatment
Start
2020-08-05
Primary completion
2024-01-25
Completion
2024-02-19
Results first posted
2025-04-01
Primary outcomes
  • Negative Symptom Assessment-16 (NSA-16) Total Score - Change From Baseline to Week 26 (26 Weeks Treatment Duration)

NCT04531982 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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