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NMDA receptor antagonist

Emraclidine for Schizophrenia

Verified Trial
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
Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI for Psychotic Disorders.
PANSS Total Score between 85 and 120, inclusive, at the time of signing the ICF and at Baseline.
Must not have
Do you have a primary diagnosis of anything other than Schizophrenia?
Do you have any condition or surgery that could possibly affect drug absorption, including, but not limited to, complicated appendectomy or cholecystectomy, bowel resections, bariatric weight loss surgery, gastric banding, or gastrectomy.
Timeline
Screening 7 days
Treatment 6 weeks
Follow Up 3 days
Awards & highlights

Study Summary

This trial will evaluate if Emraclidine is effective, safe, and tolerable in people with schizophrenia experiencing an acute exacerbation of psychosis.

Who is the study for?
This trial is for adults aged 18-65 with schizophrenia, currently experiencing a worsening of symptoms. They must have specific scores on the PANSS scale and cannot be using illicit drugs or have certain infections like HIV or hepatitis. People allergic to Emraclidine, those who've had surgeries affecting drug absorption, used Clozapine, are pregnant/breastfeeding, or recently had ECT can't participate.Check my eligibility
What is being tested?
The study tests two doses (10 mg and 30 mg) of CVL-231 (Emraclidine) against a placebo in people with schizophrenia over six weeks. It's designed to see if these doses are effective and safe in reducing psychotic symptoms compared to no treatment at all.See study design
What are the potential side effects?
While the side effects aren't specified here, common ones for antipsychotic medications may 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 below
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I have been diagnosed with schizophrenia.
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Your PANSS Total Score should be between 85 and 120 when you sign the consent form and at the start of the study.
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I am between 18 and 65 years old.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My primary diagnosis is not Schizophrenia.
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I have had surgery or a condition that might affect how my body absorbs medication.
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I have used the drug Clozapine.
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I have not had ECT treatment in the last 90 days.

Timeline

Screening ~ 7 days
Treatment ~ 6 weeks
Follow Up ~3 days
This trial's timeline: 7 days for screening, 6 weeks for treatment, and 3 days for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Syndrome
Secondary outcome measures
Change from Baseline at Week 6 in the Clinical Global Impression - Severity (CGI-S score)
Syndrome
Change from Baseline at all time points in the Clinical Global Impression - Severity (CGI-S) score
+10 more
Other 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 10 mg, once daily (QD)Experimental Treatment1 Intervention
Oral Dose
Group III: Placebo, once daily (QD)Placebo Group1 Intervention
Oral Dose

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

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

CVL-231 (NMDA receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05227690 — Phase 2
Schizophrenia Research Study Groups: CVL-231 10 mg, once daily (QD), Placebo, once daily (QD), CVL-231 30 mg, once daily (QD)
Schizophrenia Clinical Trial 2023: CVL-231 Highlights & Side Effects. Trial Name: NCT05227690 — Phase 2
CVL-231 (NMDA receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05227690 — 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 investigative endeavor permit geriatric volunteers?

"In accordance with the criteria outlined in this clinical trial, patients must be at least 18 years old to participate and no older than 65."

Answered by AI

How many subjects are receiving treatment through this research endeavor?

"To successfully execute this study, 372 suitable candidates must be recruited. Cerevel Therapeutics, LLC is sponsoring the trial and will be conducting it in two different locations: Montclair of California and Decatur of Georgia."

Answered by AI

Has CVL-231 10 mg been approved by federal regulators?

"Given the current state of clinical trials, our team at Power has assigned CVL-231 10 mg a safety score of 2. This is due to prior data indicating its relative safety but lacking evidence for efficacy."

Answered by AI

Are there any available slots remaining for participants in this clinical trial?

"Affirmative. Clinicaltrials.gov records indicate that this trial, which was initially posted on 30th June 2022, is in the process of recruiting patients. 372 individuals are sought from 13 separate medical sites."

Answered by AI

Are there numerous sites in the state where this experiment is being conducted?

"Patients for this trial are being sought at 15 distinct medical sites, including Montclair and Garden Grove in California, Decatur in Georgia, as well as 13 other locations."

Answered by AI

Are there criteria for individuals to be eligible as participants in this research endeavor?

"In order to be accepted, participants must suffer from schizophrenia and fall between the age range of 18-65. This medical research is searching for a cohort size of 372 individuals."

Answered by AI

Who else is applying?

What site did they apply to?
Oakland Park, Florida
Hialeah, Florida
Research Site - Shreveport, LA
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria

Why did patients apply to this trial?

Help with my condition. I have tried many different medications and none have given me the results I want.
PatientReceived 2+ prior treatments
Recent research and studies
clinicaltrials.govStudy
A Trial of 10 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia
2022. "A Trial of 10 and 30 mg Doses of CVL-231 (Emraclidine) in Participants With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05227690.
All > Schizophrenia
~0 spots leftby May 2024
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