Ignite Creation Date:
2025-12-24 @ 7:36 PM
Ignite Modification Date:
2025-12-31 @ 9:33 AM
Study NCT ID:
NCT05227703
Status:
COMPLETED
Last Update Posted:
2025-10-28
First Post:
2022-01-27
Is NOT Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia
Sponsor:
AbbVie
Organization:
Study Overview
Official Title:
A Phase 2, Randomized, Double-blind, Placebo-controlled Trial to Evaluate the Efficacy, Safety, and Tolerability of Two Fixed Doses (15 mg and 30 mg QD) of CVL-231 (Emraclidine) in Participants With Schizophrenia Experiencing an Acute Exacerbation of Psychosis
Status:
COMPLETED
Status Verified Date:
2025-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief 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.
Detailed Description:
The trial included up to a 15-day Screening Period (up to a maximum of 21 days allowed with approval of the medical monitor), a 45-day Inpatient Treatment Period, and a 28-day Follow-up Period. Each participant participated in the trial for up to approximately 13 weeks.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: