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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
Are you between 18-65 years old?
Have you been stable on an antipsychotic medication for a three-month period during the last year?
Must not have
Are you currently diagnosed with Bipolar Disorder or Schizoaffective Disorder
Are you currently diagnosed with Major Depressive Disorder, Post Traumatic Stress Disorder, or Obsessive Compulsive Disorder?
Timeline
Screening 15 days
Treatment 56 weeks
Follow Up 4 weeks
Awards & highlights

Summary

This trial aims to evaluate the safety and tolerability of a medication called emraclidine, taken by mouth, in adults with schizophrenia.

Who is the study for?
This trial is for adults aged 18-65 with schizophrenia who can understand the study and follow its procedures. It's not for those whose only response to treatment has been clozapine, or have progressive brain diseases, severe head trauma history, seizures (except childhood febrile seizures), or a high risk of suicide.
What is being tested?
The study is testing the long-term safety and how well people can tolerate CVL-231 (Emraclidine) at a dose of 30 mg. Emraclidine is taken orally by participants with schizophrenia to evaluate its effects over an extended period.
What are the potential side effects?
While specific side effects are not listed here, this trial aims to monitor any adverse reactions from taking oral emraclidine in patients with schizophrenia over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been stable on antipsychotic medication for the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Major Depressive Disorder, PTSD, or OCD.
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I am on three or more medications for my blood pressure.

Timeline

Screening ~ 15 days
Treatment ~ 56 weeks
Follow Up ~4 weeks
This trial's timeline: 15 days for screening, 56 weeks for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Abnormal Involuntary Movement Scale (AIMS) Score
Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Barnes Akathisia Rating Scale (BARS) Score
Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Simpson Angus Scale (SAS) Score
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CVL-231 30 mgExperimental Treatment1 Intervention
Participants will receive CVL-231 30 milligrams (mg) tablet, once daily for 52 weeks.

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.
Mechanism Of Action
Side Effect Profile
Prior Approvals
Other Research
Common treatments for schizophrenia primarily involve the modulation of neurotransmitter systems, particularly dopamine and serotonin receptors. First-generation antipsychotics typically block dopamine D2 receptors, which helps reduce psychotic symptoms but can cause side effects like parkinsonism. Second-generation antipsychotics also target serotonin receptors, which can improve efficacy and reduce some side effects. Newer treatments, such as Emraclidine, aim to modulate other neurotransmitter systems and receptors implicated in schizophrenia, potentially offering better symptom control and fewer side effects. Understanding these mechanisms is crucial for optimizing treatment, improving patient outcomes, and minimizing adverse effects.
Tricyclic antipsychotics and antidepressants can inhibit α5-containing GABA<sub>A</sub> receptors by two distinct mechanisms.Potential Utility of Biased GPCR Signaling for Treatment of Psychiatric Disorders.

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
36 Previous Clinical Trials
4,862 Total Patients Enrolled
7 Trials studying Schizophrenia
1,176 Patients Enrolled for Schizophrenia
Erica Koenig, PhDStudy DirectorCerevel Therapeutics, LLC
3 Previous Clinical Trials
895 Total Patients Enrolled
3 Trials studying Schizophrenia
895 Patients Enrolled for Schizophrenia

Media Library

CVL-231 (NMDA receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05443724 — Phase 2
Schizophrenia Clinical Trial 2023: CVL-231 Highlights & Side Effects. Trial Name: NCT05443724 — Phase 2
CVL-231 (NMDA receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05443724 — Phase 2
~34 spots leftby Nov 2024
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