A Study to Evaluate Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia
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Phase
Phase 2
Status
Completed
Study type
Interventional
Design
Na · None · Treatment
Enrollment
700actual
Sites
85
Countries
Bulgaria, Hungary, Puerto Rico +2
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2022-09-02 | actual | When the study began enrolling |
| Primary completion | 2025-06-25 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-06-25 | actual | The whole study's end, after follow-up |
| First posted | 2022-07-05 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-07-28 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Schizophrenia
Intervention
- Drug: CVL-231 30 mg — also filed as Emraclidine
Primary outcomes
what the primary-completion date above is the date OFNumber of Participants With Treatment Emergent Adverse Events (TEAEs)
measured Up to Week 56
Number of Participants With Clinically Significant Changes in Vital Sign Values
measured Up to Week 52
Number of Participants With Clinically Significant Changes in Body Weight
measured Up to Week 52
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
measured Up to Week 52
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
measured Up to Week 52
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
measured Up to Week 52
Number of Participants With Clinically Significant Changes in Metabolic Parameter Values
measured Up to Week 52
Number of Participants With Clinically Significant Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
measured Up to Week 52
Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Simpson Angus Scale (SAS) Score
measured Baseline up to Week 52
Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Abnormal Involuntary Movement Scale (AIMS) Score
measured Baseline up to Week 52
Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Barnes Akathisia Rating Scale (BARS) Score
measured Baseline up to Week 52
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