drugset / Trial / NCT05227703
A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia
RandomizedParallel-groupDouble-blindTreatment
Summary
This is a Phase 2, multicenter, randomized, double-blind, placebo-controlled, parallel-group, 6-week trial to evaluate the efficacy, safety, and tolerability of 2 fixed doses of CVL-231 (Emraclidine) (15 mg QD and 30 mg QD) in male and female adult participants who have schizophrenia and are experiencing an acute exacerbation of psychosis.
Timeline
- Start
- 2022-07-05
- Primary completion
- 2024-08-15
- Completion
- 2024-09-11
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs Emraclidine 15mg QD; p = 0.2925; LS Mean Difference -2.4 (95% CI -7.0 to 2.1) NCT05227703 ↗
registry analysis (superiority test); Placebo vs Emraclidine 30mg QD; p = 0.3914; LS Mean Difference 1.9 (95% CI -2.5 to 6.4) NCT05227703 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Emraclidine | Small molecule | 15 mg | Oral |
| Subject | Emraclidine | Small molecule | 30 mg | Oral |