Ongoing, recruitingTherapeutic exploratory (Phase II)Interventional

A 52-week, Phase 2, Open-label Trial to Evaluate the Long-term Safety and Tolerability of CVL-231 in Adult Participants With Schizophrenia

This year-long study is testing a new medicine called Emraclidine for adults who have schizophrenia. It's a 'Phase 2' study, which means researchers are still learning about the medicine. The main goal is to find out if Emraclidine is safe to use for a long time and if people can tolerate it well over 52 weeks. The study will carefully check for any side effects and how the medicine affects important body functions like heart rate and weight. This information will help doctors understand more about this potential new treatment option.

At a glance

Status

Ongoing, recruiting

Phase

Therapeutic exploratory (Phase II)

Sponsor

Cerevel Therapeutics LLC

Enrolment target

300

Start

27 Mar 2024

Schizophrenia

What is this study about?

This study is looking into a new medicine called Emraclidine for adults living with schizophrenia. Schizophrenia is a serious mental illness that affects how a person thinks, feels, and behaves. Medicines are an important part of treatment, and researchers are always trying to find new and better options.

This particular study is a 'Phase 2' trial, which means it's an important step in developing new medicines. At this stage, doctors are mainly focused on two things: safety and tolerability. They want to know if the medicine causes any unwanted side effects and if people can comfortably take it for a long period.

The study will last for 52 weeks, which is about a year. During this time, the research team will closely monitor participants. They will be looking for any side effects, checking vital signs like blood pressure and heart rate, and making sure the medicine doesn't cause any other health problems. This long-term information is crucial for understanding how Emraclidine might work as a future treatment.

Key takeaways

The study is testing a new medicine called Emraclidine for schizophrenia.
It's a year-long study focusing primarily on the medicine's safety and how well people tolerate it.
Participants will receive the study medicine and have frequent health check-ups.
The study is for adults with schizophrenia, aged 18 and older.
You can stop participating at any time if you change your mind.

Who may be eligible?

This study is open to adults aged 18 and over who have been diagnosed with schizophrenia. Both men and women can take part.

To be included, you would need to meet certain health criteria, which the study doctors would review with you. They will make sure the study setting is right for your existing health conditions.

There might be some reasons why you couldn't join, such as other medical conditions or medicines you are currently taking. The study team will go through all of this carefully with you to see if you are a good fit for the study.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you 18 years old or older?
Have you been diagnosed with schizophrenia?
Are you able to commit to a study that lasts for about a year?
Are you comfortable with regular hospital or clinic visits and medical tests?
Are you willing to take a new, experimental medicine?

Answer every question to see your result.

What does participation involve?

If you decide to take part, you will receive the study medicine, Emraclidine, for the entire 52 weeks. You will have regular visits to the clinic where doctors and nurses will monitor your health very closely.

During these visits, you can expect to have check-ups like measuring your blood pressure, temperature, and weight. You might also have blood tests, heart checks (ECGs), and physical examinations. Doctors will also check your mental health and look for any changes. They will specifically ask about your mood and any potential movement problems that can sometimes be a side effect of medicines for schizophrenia.

After you finish taking the medicine, there will likely be follow-up visits to ensure your well-being. The total duration of your involvement, including follow-up, will be around a year or slightly more.

Potential risks and benefits

Participating in this study might offer some potential benefits, like having access to a new medicine that isn't widely available yet and receiving very close medical care for your schizophrenia. However, there are also potential risks, as with any medicine. Emraclidine might cause side effects, and some of the tests or procedures could be uncomfortable. Your health might also not improve. You have the right to withdraw from the study at any time, for any reason, without it affecting your usual medical care.

Locations (2)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

—
Unverified
Hungary
—
Unverified
Bulgaria

Common questions

What is schizophrenia?

Schizophrenia is a serious, long-term mental illness that can affect how a person thinks, feels, and acts. It can cause a person to mistake reality, have confused thoughts, or lose interest in daily activities.

What does 'Phase 2' mean for a study?

Phase 2 means the medicine has been tested in a small number of people already and shown some promise. In this phase, researchers give the medicine to more people to learn more about its safety and if it works for the condition being studied.

What is Emraclidine?

Emraclidine is a new medicine being tested for schizophrenia. It's not yet approved for general use, and this study aims to gather more information about it.

How long will I be in the study?

The study treatment period is 52 weeks (about one year), with some follow-up visits afterwards. So your total involvement will be a bit over one year.

Will I get paid to be in the study?

The study information doesn't state if participants will be paid. You should ask the study team about any compensation for time and travel.