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NCT05227690 (Emraclidine in schizophrenia): BVCT ex-ante prediction vs. reported outcome

On 14 Feb 2024, BioinvestGPT's BVCT predicted technical failure and commercial failure for this trial. The 11 Nov 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
NCT05227690
Acronym
EMPOWER-1
Drug Name
Emraclidine (CVL-231)
Drug MoA
a selective CNS-penetrant CHRM4 PAM
Drug Modality
small molecule
Drug Class
First-In-Class
Therapeutic Area
Nervous System Diseases
Indication
schizophrenia
Human Patients
372
Sponsor
AbbVie
Phase
Phase 2

Prediction of , index 1458

Prospective Prediction
Prediction Index
1458
Prediction Date
Commercial Prediction
FAILURE (commercially insufficient clinical benefit)
Technical Prediction
FAILURE (statistically insignificant clinical benefit)

Readout of

Prediction Validation
Readout Date
Prediction To Readout
271 days in advance
Readout Data Interpretation
emraclidine failed to achieved the primary efficacy endpoint PANSS at week 6
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 Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses (10 mg and 30 mg QD) of CVL-231 (Emraclidine) in Participants With Schizophrenia Experiencing an Acute Exacerbation of Psychosis
Phase
Phase 2
Status
Completed
Enrollment
385
Lead sponsor
AbbVie
Conditions
Schizophrenia
Interventions
DRUG: Placebo; DRUG: Emraclidine 10 mg; DRUG: Emraclidine 30 mg
Design
Randomized · Parallel · Double
Primary purpose
Treatment
Start
2022-06-30
Primary completion
2024-08-23
Completion
2024-08-26
Results first posted
2025-09-17
Primary outcomes
  • Change From Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) Total Score (Baseline through Week 6)

NCT05227690 on ClinicalTrials.gov

Return to the dashboardClinicalTrials.gov

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