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NMDA receptor antagonist
Emraclidine for Schizophrenia
Phase 2
Recruiting
Research Sponsored by Cerevel Therapeutics, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Body mass index of 18.0 to 40.0 kg/m2 and a total body weight ≥50 kg (110 lbs).
Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for Psychotic Disorders
Timeline
Screening 3 weeks
Treatment Varies
Follow Up time frame: week 3 and week 6
Awards & highlights
Study Summary
This trial will test if a new drug, CVL-231, is effective and safe for people with schizophrenia experiencing an acute exacerbation of psychosis.
Who is the study for?
This trial is for adults with schizophrenia who are moderately to severely ill, have had a recent worsening of symptoms, and meet specific health criteria. They must not be resistant to antipsychotic treatments or have certain other mental health conditions.Check my eligibility
What is being tested?
The trial tests two doses (15 mg and 30 mg) of a drug called CVL-231 against a placebo in people with schizophrenia over six weeks to see if it's effective and safe for treating acute psychosis.See study design
What are the potential side effects?
While the side effects aren't listed here, common ones for antipsychotics include drowsiness, weight gain, dry mouth, restlessness, and sometimes more serious effects like movement disorders or metabolic changes.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My BMI is between 18 and 40, and I weigh at least 50 kg (110 lbs).
Select...
I have been diagnosed with schizophrenia.
Select...
My BMI is between 18 and 40, and I weigh at least 50 kg (110 lbs).
Select...
I have been diagnosed with schizophrenia.
Select...
My psychotic symptoms worsened less than 60 days ago.
Select...
I understand the trial's nature and can follow its requirements.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ time frame: week 3 and week 6
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~time frame: week 3 and week 6
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from Baseline at Week 6 in the Positive and Negative Syndrome Scale (PANSS) total score
Secondary outcome measures
Change from Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S score)
Change from Baseline at all time points in Positive and Negative Syndrome Scale (PANSS) total score
Change from Baseline at all time points in the Clinical Global Impression - Severity (CGI-S) score
+10 moreOther outcome measures
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
Change from Baseline at all time points in Positive and Negative Syndrome Scale (PANSS) positive, negative, and general psychopathology subscale scores
Clinical Global Impression - Improvement (CGI-I) score at Weeks 3 and 6
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: CVL-231 30 mg, once daily (QD)Experimental Treatment1 Intervention
Oral Dose
Group II: CVL-231 15 mg, once daily (QD)Experimental Treatment1 Intervention
Oral Dose
Group III: Placebo, once daily (QD)Placebo Group1 Intervention
Oral Dose
Find a Location
Who is running the clinical trial?
Cerevel Therapeutics, LLCLead Sponsor
35 Previous Clinical Trials
5,343 Total Patients Enrolled
7 Trials studying Schizophrenia
1,654 Patients Enrolled for Schizophrenia
Erica Koenig, PhDStudy DirectorCerevel Therapeutics, LLC
3 Previous Clinical Trials
1,373 Total Patients Enrolled
3 Trials studying Schizophrenia
1,373 Patients Enrolled for Schizophrenia
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not taken, nor will I need to take, any forbidden medications during the trial.I understand the trial's nature and can follow its requirements.I do not have schizophrenia, but I might have anxiety due to it. I haven't had severe depression or manic episodes needing medication in the last month.I do not have any active brain infections, diseases, or severe head injuries that could affect the study.You are moderately to severely ill.You have had a sudden and severe worsening of your psychotic symptoms within the past 60 days.I have been diagnosed with schizophrenia for the first time.I have no significant abnormal findings in my recent medical exams.My schizophrenia hasn't improved after trying at least two different medications.I am not pregnant, breastfeeding, nor planning to become pregnant soon.My BMI is between 18 and 40, and I weigh at least 50 kg (110 lbs).I am experiencing my first episode of severe mental disturbance.I do not have any major health issues that could affect my safety or the study results.I have been diagnosed with schizophrenia.My BMI is between 18 and 40, and I weigh at least 50 kg (110 lbs).Your PANSS Total Score, which is a measure of schizophrenia symptoms, must be between 85 and 120 when you agree to join the study and at the beginning of the study.My schizophrenia was diagnosed less than 2 years ago.I have a condition that might affect how my body absorbs medication.I have been diagnosed with schizophrenia.I have either responded well to clozapine or not responded at all.My psychotic symptoms worsened less than 60 days ago.I understand the trial's nature and can follow its requirements.
Research Study Groups:
This trial has the following groups:- Group 1: CVL-231 15 mg, once daily (QD)
- Group 2: CVL-231 30 mg, once daily (QD)
- Group 3: Placebo, once daily (QD)
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Schizophrenia Patient Testimony for trial: Trial Name: NCT05227703 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Does this research endeavor remain open to new participants?
"Citing clinicaltrials.gov, it is evident that this medical trial still requires participants; initially posted on June 30th 2022 and most recently edited November 8th 2022."
Answered by AI
Has the Food and Drug Administration given thumbs-up to a 15 milligram dose of CVL-231?
"With CVL-231 15 mg, our team at Power rated its safety a 2 as it is currently in Phase 2 with some evidence of safety but no data to support efficacy."
Answered by AI
How many participants is the trial accommodating at maximum capacity?
"This medical trial seeks 372 participants that satisfy all the inclusion criteria. Those interested can look into participating at clinical sites in San Diego, California and Miami Lakes, Florida."
Answered by AI
Does this trial allow for geriatric individuals to participate?
"In accordance with the eligibility requirements of this study, applicants must be aged 18 and above but not exceed 65 years old."
Answered by AI
How many research locations are actively conducting this experiment?
"Currently, 10 different medical sites are recruiting for this trial. These include locations in San Diego, Miami Lakes and Chicago; among many other cities. It is advised to pick a clinic closest to you in order to abate any travel-related difficulties associated with enrollment."
Answered by AI
What criteria must a prospective participant fulfill to be eligible for this study?
"This medical trial is currently seeking 372 persons, aged 18 to 65 years old and suffering from schizophrenia. Participants must additionally meet the following conditions: DSM-5 diagnosed psychosis (as confirmed by MINI for Psychotic Disorders), recent onset of psychotic symptoms no more than two months prior to signing informed consent form (ICF), body mass index between 18.0 to 40.0 kg/m2, total body weight at least 50kgs (110 lbs.), cognitive ability sufficient enough to understand protocol requirements as judged by investigator, Clinical Global Impression Severity score ≥4 both at ICF signing time and baseline assessment time, Positive And Negative"
Answered by AI
Who else is applying?
What state do they live in?
Georgia
Texas
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
0
3+
What site did they apply to?
Austin, Texas
Why did patients apply to this trial?
So Get Rid Of The Voices And Images. I'm in a seemingly endless downward spiral with less and less hope for my existence.
PatientReceived 2+ prior treatments
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