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

Primary Purpose

Schizophrenia

Status
Recruiting
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
CVL-231 15 mg
Required CVL-231 30 mg
Placebo
Sponsored by
Cerevel Therapeutics, LLC
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Schizophrenia focused on measuring Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Mental Disorders

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for Psychotic Disorders.
  • CGI-S ≥4 (moderately to severely ill) at the time of signing the ICF and Baseline.
  • PANSS Total Score between 85 and 120, inclusive, at the time of signing the ICF and at Baseline.
  • Experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 60 days prior to signing the ICF.
  • Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
  • Body mass index of 18.0 to 40.0 kg/m2 and a total body weight ≥50 kg (110 lbs).
  • Ability, in the opinion of the investigator, to understand the nature of the trial, participate in trial visits, and comply with protocol requirements.

Exclusion Criteria:

  • Current DSM-5 diagnosis other than schizophrenia (note: anxiety symptoms secondary to schizophrenia are allowed); 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.
  • 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
  • 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
  • Reduction (improvement) in PANSS total score of ≥20% between Screening and Baseline.
  • Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial.
  • Active central nervous system infection, demyelinating disease, degenerative neurological disease, brain tumor, prior hospitalization for severe head trauma, seizures (excluding febrile seizures in childhood), or any central nervous system disease deemed to be progressive during the course of the trial that may confound the interpretation of the trial results
  • Diagnosis of moderate to severe substance or alcohol-use disorder (excluding nicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing the ICF.
  • Risk for suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) and investigator's clinical assessment.
  • Any condition that could possibly affect drug absorption.
  • Use of prohibited medications prior to randomization within the required wash-out period or likely to require prohibited concomitant therapy during the trial.
  • Clinically significant abnormal findings on the physical examination, medical history review, ECG, or clinical laboratory results at screening.
  • Positive pregnancy test result prior to receiving IMP. Note: female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of IMP are also excluded.

Sites / Locations

  • Bentonville, Arkansas
  • Bellflower, CaliforniaRecruiting
  • La Habra, CaliforniaRecruiting
  • San Diego, CaliforniaRecruiting
  • Sherman Oaks, CaliforniaRecruiting
  • Torrance, CaliforniaRecruiting
  • New Haven, ConnecticutRecruiting
  • Homestead, FloridaRecruiting
  • Miami Lakes, FloridaRecruiting
  • Miami, FloridaRecruiting
  • Atlanta, Georgia
  • Chicago, Illinois
  • Saint Louis, Missouri
  • Berlin, New JerseyRecruiting
  • Marlton, New JerseyRecruiting
  • Charlotte, North CarolinaRecruiting
  • Austin, TexasRecruiting
  • Burgas, BurgasRecruiting
  • Lovech, LovechRecruiting
  • Pleven, PlevenRecruiting
  • Plovdiv, PlovdivRecruiting
  • Novi Iskar, SofiaRecruiting
  • Kalocsa, Bács-KiskunRecruiting
  • Budapest, BudapestRecruiting
  • GyőrRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

CVL-231 15 mg, once daily (QD)

CVL-231 30 mg, once daily (QD)

Placebo, once daily (QD)

Arm Description

Oral Dose

Oral Dose

Oral Dose

Outcomes

Primary Outcome Measures

Change from Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) total score
The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.

Secondary Outcome Measures

Change from Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S score)
The CGI-S captures clinician's response to: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.
Change from Baseline at all time points in Positive and Negative Syndrome Scale (PANSS) total score
The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Change from Baseline at all time points in the Clinical Global Impression - Severity (CGI-S) score
The CGI-S captures clinician's response to: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.
Percentage of responders at Week 6 (responders defined as ≥30% reduction from Baseline in PANSS total score)
A PANSS responder is defined as a participant with at least a 30% change in PANSS total score compared to baseline at Week 6.
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward will be counted as treatment-emergent AE (TEAE)
Incidence of clinically significant changes in electrocardiogram (ECG) results
Assessment of clinically significant changes in electrocardiogram measures measured by 12-lead ECG recording after the participant has been supine and at rest for at least 3 minutes
Incidence of clinically significant changes in clinical laboratory results
Incidence of clinically significant changes in vital sign measurements
Assessment of clinically significant changes in vital signs including temperature, systolic and diastolic blood pressure, and heart rate.
Incidence of clinically significant changes in physical and neurological examination results
Clinically significant findings in suicidality assessed using the Columbia Suicide-Severity Rating Scale (C-SSRS)
The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Frequency of clinically significant findings in extrapyramidal symptoms evaluated using the Simpson Angus Scale (SAS)
The SAS consists of a list of 10 symptoms of parkinsonism. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items.
Frequency of clinically significant findings in extrapyramidal symptoms evaluated using the Barnes Akathisia Rating Scale (BARS)
The BARS consists of 4 items related to akathisia: The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with a score of 0 representing absence of symptom and a score of 5 representing severe akathisia.
Frequency of clinically significant findings in extrapyramidal symptoms evaluated using the Abnormal Involuntary Movement Scale (AIMS)
The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the subject's dental status.

Full Information

First Posted
January 27, 2022
Last Updated
October 16, 2023
Sponsor
Cerevel Therapeutics, LLC
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1. Study Identification

Unique Protocol Identification Number
NCT05227703
Brief Title
A Trial of 15 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2023
Overall Recruitment Status
Recruiting
Study Start Date
June 30, 2022 (Actual)
Primary Completion Date
May 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Cerevel Therapeutics, LLC

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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 participants who have schizophrenia and are experiencing an acute exacerbation of psychosis.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Schizophrenia
Keywords
Schizophrenia, Schizophrenia Spectrum and Other Psychotic Disorders, Mental Disorders

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Model Description
Placebo-controlled
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
372 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
CVL-231 15 mg, once daily (QD)
Arm Type
Experimental
Arm Description
Oral Dose
Arm Title
CVL-231 30 mg, once daily (QD)
Arm Type
Experimental
Arm Description
Oral Dose
Arm Title
Placebo, once daily (QD)
Arm Type
Placebo Comparator
Arm Description
Oral Dose
Intervention Type
Drug
Intervention Name(s)
CVL-231 15 mg
Intervention Description
CVL-231 15 mg, oral (tablet), once per day for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Required CVL-231 30 mg
Intervention Description
CVL-231 30 mg, oral (tablet), once per day for 6 weeks
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Matching placebo, oral (tablet), once per day for 6 weeks
Primary Outcome Measure Information:
Title
Change from Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) total score
Description
The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Time Frame
Baseline through Week 6
Secondary Outcome Measure Information:
Title
Change from Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S score)
Description
The CGI-S captures clinician's response to: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.
Time Frame
Baseline through Week 6
Title
Change from Baseline at all time points in Positive and Negative Syndrome Scale (PANSS) total score
Description
The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Time Frame
Baseline through Week 6
Title
Change from Baseline at all time points in the Clinical Global Impression - Severity (CGI-S) score
Description
The CGI-S captures clinician's response to: "Considering your total clinical experience, how mentally ill is the participant at this time?" The clinician's answer rated on the following 7-point scale: 1 = normal, not at all ill; 2 = borderline mentally ill; 3 = mildly ill; 4 = moderately ill; 5 = markedly ill; 6 = severely ill; 7 = among the most extremely ill participants.
Time Frame
Baseline through Week 6
Title
Percentage of responders at Week 6 (responders defined as ≥30% reduction from Baseline in PANSS total score)
Description
A PANSS responder is defined as a participant with at least a 30% change in PANSS total score compared to baseline at Week 6.
Time Frame
Baseline through Week 6
Title
Incidence and Severity of Treatment Emergent Adverse Events (TEAEs)
Description
Any AE occurring following the start of treatment or occurring before treatment but increasing in severity afterward will be counted as treatment-emergent AE (TEAE)
Time Frame
Up to Week 10
Title
Incidence of clinically significant changes in electrocardiogram (ECG) results
Description
Assessment of clinically significant changes in electrocardiogram measures measured by 12-lead ECG recording after the participant has been supine and at rest for at least 3 minutes
Time Frame
Up to Week 6
Title
Incidence of clinically significant changes in clinical laboratory results
Time Frame
Up to Week 6
Title
Incidence of clinically significant changes in vital sign measurements
Description
Assessment of clinically significant changes in vital signs including temperature, systolic and diastolic blood pressure, and heart rate.
Time Frame
Up to Week 6
Title
Incidence of clinically significant changes in physical and neurological examination results
Time Frame
Up to Week 6
Title
Clinically significant findings in suicidality assessed using the Columbia Suicide-Severity Rating Scale (C-SSRS)
Description
The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).
Time Frame
Up to Week 6
Title
Frequency of clinically significant findings in extrapyramidal symptoms evaluated using the Simpson Angus Scale (SAS)
Description
The SAS consists of a list of 10 symptoms of parkinsonism. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items.
Time Frame
Up to Week 6
Title
Frequency of clinically significant findings in extrapyramidal symptoms evaluated using the Barnes Akathisia Rating Scale (BARS)
Description
The BARS consists of 4 items related to akathisia: The first 3 items are rated on a 4-point scale, with a score of 0 representing absence of symptoms and a score of 3 representing a severe condition. The global clinical evaluation is made on a 6-point scale, with a score of 0 representing absence of symptom and a score of 5 representing severe akathisia.
Time Frame
Up to Week 6
Title
Frequency of clinically significant findings in extrapyramidal symptoms evaluated using the Abnormal Involuntary Movement Scale (AIMS)
Description
The AIMS assessment consists of 10 items describing symptoms of dyskinesia. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the subject's dental status.
Time Frame
Up to Week 6
Other Pre-specified Outcome Measures:
Title
Clinical Global Impression - Improvement (CGI-I) score at Weeks 3 and 6
Description
The CGI-I captures clinician's response to: "Rate total improvement whether or not, in your judgment, it is due entirely to drug treatment. Compared to his/her condition at admission to the project (screening) how much has he /she changed? 0 = Not assessed 1 = Very much improved 2 = Much improved 3 = Minimally improved 4 = No change 5 = Minimally worse 6 = Much worse 7 = Very much worse
Time Frame
Time Frame: Week 3 and Week 6
Title
Change from Baseline at all time points in Positive and Negative Syndrome Scale (PANSS) positive, negative, and general psychopathology subscale scores
Description
The PANSS measures symptom severity of participants with schizophrenia and contains 7 positive symptom scales, 7 negative system scales, and 16 general psychopathology symptom scales. Participants are rated from 1 to 7 on each symptom scale with a total minimum score of 30 and a maximum score of 210. A decrease in PANSS total score correlates with an improvement in schizophrenia symptoms.
Time Frame
Every week from baseline through Week 6
Title
Change from Baseline at all time points in PANSS Marder Factor scores Change from Baseline at all time points in PANSS Marder Factor scores Change from Baseline at all time points in PANSS Marder Factor scores
Description
The Negative Marder Factor score is calculated as the sum of the rating assigned to each of the 7 applicable Marder factor items, and ranges from 7 to 49 with a higher score indicating greater severity of symptoms.
Time Frame
Every week from baseline through Week 6

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for Psychotic Disorders. CGI-S ≥4 (moderately to severely ill) at the time of signing the ICF and Baseline. PANSS Total Score between 85 and 120, inclusive, at the time of signing the ICF and at Baseline. Experiencing an acute exacerbation or relapse of psychotic symptoms, with onset less than 60 days prior to signing the ICF. Willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period. Body mass index of 18.0 to 40.0 kg/m2 and a total body weight ≥50 kg (110 lbs). Ability, in the opinion of the investigator, to understand the nature of the trial, participate in trial visits, and comply with protocol requirements. Exclusion Criteria: Current DSM-5 diagnosis other than schizophrenia (note: anxiety symptoms secondary to schizophrenia are allowed); 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. 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 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 Reduction (improvement) in PANSS total score of ≥20% between Screening and Baseline. Current or past history of significant cardiovascular, pulmonary, gastrointestinal, renal, hepatic, metabolic, genitourinary, endocrine (including diabetes mellitus), malignancy (except for basal cell carcinoma of the skin and cervical carcinoma in situ, at the discretion of the investigator), hematological, immunological, neurological, or psychiatric disease that, in the opinion of the investigator or medical monitor, could compromise either participant safety or the results of the trial. Active central nervous system infection, demyelinating disease, degenerative neurological disease, brain tumor, prior hospitalization for severe head trauma, seizures (excluding febrile seizures in childhood), or any central nervous system disease deemed to be progressive during the course of the trial that may confound the interpretation of the trial results Diagnosis of moderate to severe substance or alcohol-use disorder (excluding nicotine or caffeine) as per DSM-5 criteria within 12 months prior to signing the ICF. Risk for suicidal behavior as assessed by the Columbia-Suicide Severity Rating Scale (C-SSRS) and investigator's clinical assessment. Any condition that could possibly affect drug absorption. Use of prohibited medications prior to randomization within the required wash-out period or likely to require prohibited concomitant therapy during the trial. Clinically significant abnormal findings on the physical examination, medical history review, ECG, or clinical laboratory results at screening. Positive pregnancy test result prior to receiving IMP. Note: female participants who are pregnant, breastfeeding, or planning to become pregnant during IMP treatment or within 7 days after the last dose of IMP are also excluded.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Cerevel Clinical Trial Support
Email
cerevelclinicaltrials@cerevel.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Erica Koenig, PhD
Organizational Affiliation
Cerevel Therapeutics, LLC
Official's Role
Study Director
Facility Information:
Facility Name
Bentonville, Arkansas
City
Bentonville
State/Province
Arkansas
ZIP/Postal Code
72712
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Bellflower, California
City
Bellflower
State/Province
California
ZIP/Postal Code
90706-7079
Country
United States
Individual Site Status
Recruiting
Facility Name
La Habra, California
City
La Habra
State/Province
California
ZIP/Postal Code
90631-3842
Country
United States
Individual Site Status
Recruiting
Facility Name
San Diego, California
City
San Diego
State/Province
California
ZIP/Postal Code
92103-2209
Country
United States
Individual Site Status
Recruiting
Facility Name
Sherman Oaks, California
City
Sherman Oaks
State/Province
California
ZIP/Postal Code
91403-1747
Country
United States
Individual Site Status
Recruiting
Facility Name
Torrance, California
City
Torrance
State/Province
California
ZIP/Postal Code
90502-4432
Country
United States
Individual Site Status
Recruiting
Facility Name
New Haven, Connecticut
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06519-1109
Country
United States
Individual Site Status
Recruiting
Facility Name
Homestead, Florida
City
Homestead
State/Province
Florida
ZIP/Postal Code
33032-8187
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami Lakes, Florida
City
Miami Lakes
State/Province
Florida
ZIP/Postal Code
33016-1553
Country
United States
Individual Site Status
Recruiting
Facility Name
Miami, Florida
City
Miami
State/Province
Florida
ZIP/Postal Code
33122-1335
Country
United States
Individual Site Status
Recruiting
Facility Name
Atlanta, Georgia
City
Atlanta
State/Province
Georgia
ZIP/Postal Code
30331-2012
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Chicago, Illinois
City
Chicago
State/Province
Illinois
ZIP/Postal Code
60641
Country
United States
Individual Site Status
Active, not recruiting
Facility Name
Saint Louis, Missouri
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63125-2408
Country
United States
Individual Site Status
Withdrawn
Facility Name
Berlin, New Jersey
City
Berlin
State/Province
New Jersey
ZIP/Postal Code
08009
Country
United States
Individual Site Status
Recruiting
Facility Name
Marlton, New Jersey
City
Marlton
State/Province
New Jersey
ZIP/Postal Code
08053
Country
United States
Individual Site Status
Recruiting
Facility Name
Charlotte, North Carolina
City
Charlotte
State/Province
North Carolina
ZIP/Postal Code
28211-4849
Country
United States
Individual Site Status
Recruiting
Facility Name
Austin, Texas
City
Austin
State/Province
Texas
ZIP/Postal Code
78754-5122
Country
United States
Individual Site Status
Recruiting
Facility Name
Burgas, Burgas
City
Burgas
ZIP/Postal Code
8000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Lovech, Lovech
City
Lovech
ZIP/Postal Code
5500
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Pleven, Pleven
City
Pleven
ZIP/Postal Code
5800
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Plovdiv, Plovdiv
City
Plovdiv
ZIP/Postal Code
4000
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Novi Iskar, Sofia
City
Sofia
ZIP/Postal Code
1282
Country
Bulgaria
Individual Site Status
Recruiting
Facility Name
Kalocsa, Bács-Kiskun
City
Kalocsa
State/Province
Bács-Kiskun
ZIP/Postal Code
6300
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Budapest, Budapest
City
Budapest
ZIP/Postal Code
1083
Country
Hungary
Individual Site Status
Recruiting
Facility Name
Győr
City
Győr
ZIP/Postal Code
9028
Country
Hungary
Individual Site Status
Recruiting

12. IPD Sharing Statement

Learn more about this trial

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

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