A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia

Phase 1

• Conditions: Patients with schizophrenia who are experiencing an acute exacerbation of psychosis; MedDRA version: 20.0Level: HLGTClassification code 10039628Term: Schizophrenia and other psychotic disordersSystem Organ Class: 10037175 - Psychiatric disorders; MedDRA version: 20.0Level: PTClassification code 10039626Term: SchizophreniaSystem Organ Class: 10037175 - Psychiatric disorders; Therapeutic area: Psychiatry and Psychology [F] - Mental Disorders [F03]

• Registration Number: EUCTR2022-000581-17-BG
• Lead Sponsor: Cerevel Therapeutics, LLC

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-08-18
• Last Update Posted: 4 December 2023

Recruitment & Eligibility

• Status: Authorised-recruitment may be ongoing or finished
• Sex: All
• Target Recruitment: 600

Inclusion Criteria

1. Male and female participants, ages 18 to 65 years, inclusive, at the time of signing the ICF
2. Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for Psychotic Disorders version 7.0.2
3. CGI-S =4 (moderately to severely ill) at the time of signing the ICF and Baseline
4. PANSS Total Score between 85 and 120, inclusive, at the time of signing the ICF and at Baseline. Additionally, participants must meet a score of =4 (moderate or greater) for =2 of the following Positive Scale items at the time of signing the ICF and at Baseline:
• Positive Scale Item 1 (delusions)
• Positive Scale Item 2 (conceptual disorganization)
• Positive Scale Item 3 (hallucinatory behavior)
• Positive Scale Item 6 (suspiciousness/persecution)
5. Experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 60 days prior to signing the ICF.
• Participant requires hospitalization for this acute exacerbation or relapse of symptoms
• If participant is already an inpatient at the time of signing the ICF, has been hospitalized for =14 days for the current episode of psychosis at the time of signing the ICF, excluding hospitalization for psychosocial reasons
6. Scores as follows (normal to mild symptoms) at the time of signing the ICF and Baseline (Day 1):
• All individual items of the SAS <2
• All individual items (Items 1-7) of the AIMS <2
• Clinical global assessment item of the BARS <3
7.Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
8.Resides in a stable living environment as demonstrated by the ability to provide contact information for themselves and/or family/friend/caregiver.
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 600
F.1.3 Elderly (>=65 years) no
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1.Current DSM-5 diagnosis other than schizophrenia including, but not limited to, intellectual disability; schizoaffective disorder; major depressive disorder; schizophreniform disorder; psychotic depression; bipolar disorder; post-traumatic stress disorder; generalized anxiety disorder, obsessive compulsive disorder, eating disorders (bulimia, anorexia), or other anxiety disorders as a primary diagnosis (note: anxiety symptoms secondary to schizophrenia are allowed); delirium, dementia, amnestic, or other cognitive disorders.
Acute depressive symptoms within 30 days prior to signing the ICF that require treatment with an antidepressant are exclusory.
Acute manic symptoms within 30 days prior to signing the ICF that require treatment with a mood stabilizer are exclusory.
Additional excluded conditions include borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
2.Any of the following:
• Schizophrenia considered resistant/refractory to antipsychotic treatment by history (failure to respond to 2 or more courses of adequate pharmacological treatment defined as an adequate dose per label and a treatment duration of at least 4 weeks)
• History of response to clozapine treatment only or failure to respond to clozapine treatment for schizophrenia
3.Any of the following regarding history of schizophrenia:
• Time from initial onset of schizophrenia <2 years based on prior records or participant self-report
• Presenting with an initial diagnosis of schizophrenia
• Presenting for the first time with an acute psychotic episode requiring treatment
4.Reduction (improvement) in PANSS total score of =20% between Screening and Baseline.
5.Either of the following:
• History of tardive dyskinesia
• Extrapyramidal symptoms that required medication within 6 months prior to signing the ICF

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: To evaluate the efficacy of 2 fixed oral doses (15 mg QD and 30 mg QD) of emraclidine in adult participants with schizophrenia experiencing an acute exacerbation of psychosis;Secondary Objective: To evaluate the safety and tolerability of 2 fixed oral doses (15 mg QD and 30 mg QD) of emraclidine in adult participants with schizophrenia experiencing an acute exacerbation of psychosis;Primary end point(s): Change from Baseline at Week 6 in the PANSS total score;Timepoint(s) of evaluation of this end point: Week 6

Secondary Outcome Measures

Name	Time	Method
Secondary end point(s): Change from Baseline at Week 6 in the CGI-S score;Timepoint(s) of evaluation of this end point: Week 6