drugset / Trial / NCT05227690
A Trial of 10 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) (10 mg QD and 30 mg QD) in male and female participants who have schizophrenia and are experiencing an acute exacerbation of psychosis.
Timeline
- Start
- 2022-06-30
- Primary completion
- 2024-08-23
- Completion
- 2024-08-26
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs Emraclidine 30 mg, Once Daily (QD); p =0.1765; LS Mean Difference -3.0 (95% CI -7.5 to 1.4) NCT05227690 ↗
registry analysis (superiority test); Placebo vs Emraclidine 10 mg, Once Daily (QD); p =0.6007; LS Mean Difference -1.2 (95% CI -5.6 to 3.3) NCT05227690 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Emraclidine | Small molecule | 10 mg | Oral |
| Subject | Emraclidine | Small molecule | 30 mg | Oral |