CVL-231 for Schizophrenia
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests an experimental treatment, CVL-231 (also known as Emraclidine), to observe its effects on certain brain receptors. The main focus is to understand how well this drug interacts with muscarinic receptors type 4 in the brain after oral administration. The trial seeks healthy men and women (who cannot have children) between 18 and 55 years old. Participants should not have any major health issues or a history of psychiatric disorders. As a Phase 1 trial, this research aims to understand how the treatment works in people, offering participants the opportunity to be among the first to receive this new treatment.
Do I need to stop my current medications to join the trial?
The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial team or your doctor.
Is there any evidence suggesting that CVL-231 is likely to be safe for humans?
Research shows that CVL-231, also known as emraclidine, is under study for its safety in humans. These studies focus on adults with schizophrenia to assess its long-term safety and tolerability. The goal is to ensure the treatment does not cause serious side effects with ongoing use.
Although detailed results from these studies are not yet available, the testing of CVL-231 in humans suggests it demonstrated some safety in earlier tests, often conducted on animals or in a lab.
CVL-231 works by affecting certain parts of the brain, potentially reducing symptoms without causing major harm. However, like any new treatment, risks may exist. Joining a clinical trial involves understanding these risks. Consulting a healthcare provider can help determine if participating in a trial is appropriate.12345Why do researchers think this study treatment might be promising?
Researchers are excited about CVL-231 because it offers a novel approach to treating conditions like schizophrenia. Unlike standard treatments that generally target dopamine receptors, CVL-231 focuses on muscarinic receptors in the brain, which may result in fewer side effects like weight gain or sedation. This unique mechanism of action could potentially provide a more effective and tolerable treatment option for patients.
What evidence suggests that CVL-231 might be an effective treatment for muscarinic receptor occupancy in the brain?
Research shows that CVL-231, the investigational treatment in this trial, may help treat schizophrenia. In earlier studies, patients taking CVL-231 experienced fewer core symptoms of schizophrenia. Importantly, most participants tolerated CVL-231 well in these studies. The drug affects certain brain receptors that help control mood and perception. Early results suggest this method could manage symptoms without many common side effects of other treatments. While more research is needed, these initial findings are promising.26789
Who Is on the Research Team?
Matthew Leoni, MD, MBA
Principal Investigator
Cerevel Therapeutics, LLC
Are You a Good Fit for This Trial?
Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single oral dose of CVL-231 and undergo PET scans to evaluate M4 receptor occupancy
Follow-up
Participants are monitored for safety and effectiveness after treatment, including suicidality assessment
What Are the Treatments Tested in This Trial?
Interventions
- CVL-231
Find a Clinic Near You
Who Is Running the Clinical Trial?
Cerevel Therapeutics, LLC
Lead Sponsor