Long-term Safety Study of Emraclidine for Adults with Schizophrenia

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What is this study about?

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.

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 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 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 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 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 Study?

  • 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 Study?

  • 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.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

No sites found in this category

Other Sites

Site Name City Country Status
Medical Center Hera EOOD Sofia Bulgaria
Umbal – Prof. D-R Stoyan Kirkovich AD Stara Zagora Bulgaria
Diagnostics-Consultancy Center Mladost M Varna OOD Varna Bulgaria
Diagnostic Consultative Center 14 Sofia EOOD Sofia Bulgaria
Center Za Psihichno Zdrave Veliko Tarnovo EOOD Veliko Tirnovo Bulgaria
Diagnostic-consultative center “Aleksandrovska” EOOD Sofia Bulgaria
Semmelweis University Budapest Hungary
MBAL Dr. Ivan Seliminski – Sliven AD Sliven Bulgaria
Multi-profile Hospital for Active Treatment Heart and Brain EAD Pleven Bulgaria
Medical Center Intermedica Ltd. Sofia Bulgaria
Higya–DCC OOD Pazardzhik Bulgaria
Ogshmshone cccjqi ftz grbaj pzztffyh fxe sydkdubmhhh mfomjww hpno &chawdb Psypcu Odr Sofia Bulgaria
Avlvxjtdbw &vfhixx Gavod Pclbbofn fyl Slsubjblxcx Ptiloqdgetq Csgc Dhhwozz Pleven Bulgaria
Cmjcbg Fzq Mwbanw Htffyq Vnheyz Epkz Vratsa Bulgaria
Mtspgy Hvtike Cxhrvr Slhiv Etcv Sofia Bulgaria
Beovgvutktw Vgdlfebkx Olwtzaabhzum Kecskemet Hungary
Geqqqjqwjndjlroyl Vnkucwpqc Pzkv Ahbgxw Emxynqil Ouxtbr Khaflr Gyor Hungary
Mlumjvh Csdofq Mrpcsmlgzi Prqmyp Osy Pleven Bulgaria

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Bulgaria Bulgaria
Not recruiting
01.04.2024
Hungary Hungary
Not recruiting
01.04.2024

Trial locations

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.

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 ID:
2024-511441-19-00
Protocol code:
CVL-231-2003
NCT ID:
NCT05443724
Trial Phase:
Therapeutic exploratory (Phase II)

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