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Long-term Safety Study of Emraclidine for Adults with Schizophrenia

Verified siteInvestigationalNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying schizophrenia, a mental health condition that affects how a person thinks, feels, and behaves. The trial will use a medication called emraclidine, also known by its code name CVL-231. The purpose of the study is to evaluate the long-term safety and tolerability of this medication in adults who have schizophrenia.

Participants in the study will take emraclidine in the form of a tablet, which is taken orally. The study will last for 52 weeks, during which time participants will be monitored to see how well they tolerate the medication and to check for any side effects. The study is open-label, meaning that both the participants and the researchers know which treatment is being administered. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects of emraclidine.

Throughout the study, participants will have regular visits with the research team to assess their health and any changes in their condition. These visits will include physical and neurological examinations, as well as assessments of vital signs, body weight, and other health parameters. The study aims to provide valuable information about the long-term use of emraclidine for treating schizophrenia, helping to determine its safety and effectiveness for future use.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial visit

    Upon joining the trial, an initial visit is conducted to confirm eligibility. This includes a review of medical history and current health status.

    Participants must have a primary diagnosis of schizophrenia and meet specific health criteria, such as stable living conditions and a body mass index between 18.0 and 40.0 kg/m².

  2. Step 2

    Medication administration

    Participants will begin taking the medication emraclidine in tablet form. The medication is taken orally.

    The dosage and frequency of administration will be determined by the trial protocol and monitored by the trial team.

  3. Step 3

    Regular monitoring

    Throughout the 52-week trial, participants will attend regular visits to monitor health and response to the medication.

    These visits will include assessments of vital signs, body weight, and other health parameters to ensure safety and tolerability.

  4. Step 4

    Safety assessments

    Participants will undergo various assessments to monitor for any adverse effects. This includes physical and neurological examinations, ECG assessments, and laboratory tests.

    The trial will also evaluate any changes in symptoms related to schizophrenia and overall mental health.

  5. Step 5

    Completion of trial

    At the end of the 52-week period, a final assessment will be conducted to evaluate the long-term safety and tolerability of emraclidine.

    Participants will receive guidance on next steps regarding their treatment and health management.

Who can join the trial?

13 criteria

  • Participants must have completed 6 weeks of treatment in a previous trial and could benefit from the study medication for **schizophrenia**.
  • Participants should be in an **outpatient status** at the end of the previous trial, meaning they can leave the hospital.
  • Participants must agree to use **contraception** during the trial and for 7 days after the last dose if they are sexually active women who can have children.
  • Participants must be able to give **informed consent**, which means they understand the trial and agree to follow its rules.
  • Participants should be able to understand the trial, attend visits, and follow the trial's requirements, like taking the medication and doing tests.
  • Participants should be between 18 and 65 years old.
  • Participants must have a primary diagnosis of **schizophrenia** confirmed by a specific interview.
  • Participants should have been stable on their current medication for at least 3 months in the past year.
  • Participants should be in an **outpatient status** at the time of joining the trial, meaning they are not staying in a hospital for their condition.
  • Participants must have certain scores on specific assessments that show their symptoms are mild or normal.
  • Participants must be willing to stop taking any medications that are not allowed during the trial.
  • Participants should live in a stable environment and be able to provide contact information.
  • Participants must have a **body mass index (BMI)** between 18.0 and 40.0 and weigh at least 50 kg (110 lbs).

Who cannot join the trial?

4 criteria

  • Individuals who do not have a diagnosis of schizophrenia cannot participate. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves.
  • Participants must be within a certain age range, typically adults, to be eligible.
  • Both males and females are eligible, but certain health conditions or factors may exclude someone.
  • People who are considered part of a vulnerable population may not be eligible. This term refers to groups who might be at a higher risk of harm or exploitation, such as those with limited ability to give informed consent.
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Investigated drugs

Emraclidine is a medication being studied for its long-term safety and tolerability in adults with schizophrenia. It is taken orally and is part of a clinical trial to understand how well patients can tolerate it over an extended period. The trial aims to ensure that the medication is safe for long-term use in managing symptoms of schizophrenia.

What is already known about the treatment

Emraclidine – Emraclidine is administered orally and is currently being studied in clinical trials for its long-term safety and tolerability in treating schizophrenia. It is not yet widely recognized in medical literature as it is still under investigation. The main therapeutic indication for emraclidine is schizophrenia, a mental health disorder characterized by disruptions in thought processes, perceptions, emotional responsiveness, and social interactions. At the molecular level, emraclidine works by modulating specific neurotransmitter receptors in the brain, which are believed to play a role in the symptoms of schizophrenia. It is classified pharmacologically as a modulator of neurotransmitter systems.

Investigated diseases

Schizophrenia – Schizophrenia is a chronic mental health disorder that affects how a person thinks, feels, and behaves. Individuals with this condition may experience hallucinations, delusions, and disorganized thinking. These symptoms can lead to difficulties in distinguishing between what is real and what is not. The disorder often begins in late adolescence or early adulthood and can vary in severity. Over time, it may impact a person's ability to function in daily life, affecting relationships and work. The progression of symptoms can fluctuate, with periods of worsening and improvement.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IITrial ID2024-511441-19-00Protocol codeCVL-231-2003Estimated enrolment850 patientsSponsorCerevel Therapeutics LLC

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