What side effects are associated with this type of intervention?

Common treatments for schizophrenia primarily include first-generation and second-generation antipsychotics. First-generation antipsychotics, such as haloperidol and chlorpromazine, often cause extrapyramidal side effects (e.g., tremors, rigidity), tardive dyskinesia, and neuroleptic malignant syndrome. Second-generation antipsychotics, like risperidone, olanzapine, and quetiapine, tend to have fewer extrapyramidal side effects but can cause weight gain, metabolic syndrome, and sedation. Specific to selective M1 muscarinic acetylcholine receptor modulators like CVL-231 (Emraclidine), detailed side effect profiles are still under investigation, but they may offer a different side effect profile compared to traditional antipsychotics.

What prior FDA approvals exist?

The FDA has approved several antipsychotic medications for the treatment of schizophrenia, primarily focusing on dopamine and serotonin receptor antagonists. These include first-generation antipsychotics like haloperidol and chlorpromazine, and second-generation (atypical) antipsychotics such as risperidone, olanzapine, and clozapine. While CVL-231 (Emraclidine) is a selective M1 muscarinic acetylcholine receptor positive allosteric modulator, there is limited information on FDA-approved drugs with a similar mechanism of action. Most current treatments target dopamine and serotonin pathways rather than muscarinic acetylcholine receptors.

What other types of research exist?

Promising novel alternatives to CVL-231 for schizophrenia treatment in 2024 include: 1) SEP-363856, a novel trace amine-associated receptor 1 (TAAR1) agonist, which has shown efficacy in reducing schizophrenia symptoms without the typical side effects associated with dopamine antagonists. 2) KarXT, a combination of xanomeline (a muscarinic receptor agonist) and trospium (a muscarinic receptor antagonist), which has demonstrated significant improvements in both positive and negative symptoms of schizophrenia. 3) Ulotaront (SEP-363856), which targets TAAR1 and serotonin 5-HT1A receptors, offering a new mechanism of action distinct from traditional antipsychotics.

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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

Summary

This trial is testing a medication called Emraclidine in people with schizophrenia who are having a worsening of their symptoms. Emraclidine works by targeting brain chemicals to help reduce psychotic episodes.

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.

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.

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 days1 visit

Treatment ~ 6 weeks9 visits

Follow Up ~ 3 days1 visit

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Syndrome

Secondary study objectives

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 study objectives

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

0 / 9Eligibility criteria met

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 include first-generation antipsychotics (FGAs) and second-generation antipsychotics (SGAs). FGAs primarily block dopamine D2 receptors to reduce psychotic symptoms but can cause side effects like parkinsonism. SGAs also target dopamine D2 receptors and serotonin receptors, improving efficacy and reducing some side effects. Newer treatments like CVL-231 (Emraclidine), a selective M1 muscarinic acetylcholine receptor positive allosteric modulator, modulate acetylcholine signaling, potentially enhancing cognitive function and reducing side effects. Understanding these mechanisms helps tailor treatments to individual needs, improving patient outcomes.

Potential Utility of Biased GPCR Signaling for Treatment of Psychiatric Disorders.