A 52-week, Phase 2, Open-label Trial to Evaluate the Long-term Safety and Tolerability of CVL-231 in Adult Participants With Schizophrenia

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2024-511441-19-00

Acronym

CVL-231-2003

Enrollment

300

Registered

2024-03-27

Start date

2023-03-08

Completion date

2025-04-22

Last updated

2025-05-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Schizophrenia

Brief summary

"• Treatment-emergent adverse events • Clinically significant changes in vital sign measurements, body weight, physical and neurological examination results, ECG assessments, clinical laboratory assessments, and metabolic parameters • Clinically significant findings in suicidality assessed using the C-SSRS • Extrapyramidal symptoms evaluated using the change from Baseline in SAS, AIMS, and BARS assessments "

Interventions

DRUGEMRACLIDINE

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
"• Treatment-emergent adverse events • Clinically significant changes in vital sign measurements, body weight, physical and neurological examination results, ECG assessments, clinical laboratory assessments, and metabolic parameters • Clinically significant findings in suicidality assessed using the C-SSRS • Extrapyramidal symptoms evaluated using the change from Baseline in SAS, AIMS, and BARS assessments "	—

Measure

Time frame

—

Countries

Bulgaria, Hungary

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026