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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
Are you between 18-65 years old?
Have you been stable on an antipsychotic medication for a three-month period during the last year?
Must not have
Are you currently diagnosed with Bipolar Disorder or Schizoaffective Disorder
Are you currently diagnosed with Major Depressive Disorder, Post Traumatic Stress Disorder, or Obsessive Compulsive Disorder?
Timeline
Screening 15 days
Treatment 56 weeks
Follow Up 4 weeks
Awards & highlights

Study Summary

This trial will study the long-term effects of a new drug, emraclidine, on people with schizophrenia.

Who is the study for?
This trial is for adults aged 18-65 with schizophrenia who can understand the study and follow its procedures. It's not for those whose only response to treatment has been clozapine, or have progressive brain diseases, severe head trauma history, seizures (except childhood febrile seizures), or a high risk of suicide.Check my eligibility
What is being tested?
The study is testing the long-term safety and how well people can tolerate CVL-231 (Emraclidine) at a dose of 30 mg. Emraclidine is taken orally by participants with schizophrenia to evaluate its effects over an extended period.See study design
What are the potential side effects?
While specific side effects are not listed here, this trial aims to monitor any adverse reactions from taking oral emraclidine in patients with schizophrenia over time.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am between 18 and 65 years old.
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I have been stable on antipsychotic medication for the last 3 months.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with Major Depressive Disorder, PTSD, or OCD.
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I am on three or more medications for my blood pressure.

Timeline

Screening ~ 15 days
Treatment ~ 56 weeks
Follow Up ~4 weeks
This trial's timeline: 15 days for screening, 56 weeks for treatment, and 4 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Abnormal Involuntary Movement Scale (AIMS) Score
Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Barnes Akathisia Rating Scale (BARS) Score
Number of Participants With Change from Baseline in Extrapyramidal Symptoms Measured by the Simpson Angus Scale (SAS) Score
+8 more

Trial Design

1Treatment groups
Experimental Treatment
Group I: CVL-231 30 mgExperimental Treatment1 Intervention
Participants will receive CVL-231 30 milligrams (mg) tablet, once daily for 52 weeks.

Find a Location

Logistics

Other reimbursement is provided

Other forms of reimbursement are provided for this trial.

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
35 Previous Clinical Trials
4,865 Total Patients Enrolled
7 Trials studying Schizophrenia
1,176 Patients Enrolled for Schizophrenia
Erica Koenig, PhDStudy DirectorCerevel Therapeutics, LLC
3 Previous Clinical Trials
895 Total Patients Enrolled
3 Trials studying Schizophrenia
895 Patients Enrolled for Schizophrenia

Media Library

CVL-231 (NMDA receptor antagonist) Clinical Trial Eligibility Overview. Trial Name: NCT05443724 — Phase 2
Schizophrenia Clinical Trial 2023: CVL-231 Highlights & Side Effects. Trial Name: NCT05443724 — Phase 2
CVL-231 (NMDA receptor antagonist) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05443724 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What have been the observed effects of administering CVL-231 30 mg to individuals?

"Our analysis at Power rated the safety of CVL-231 30 mg as a 2 due to limited evidence in regards to its efficacy, although there is some data that suggests it may be safe."

Answered by AI

Are volunteers being recruited for this trial at the present moment?

"According to clinicaltrials.gov, this investigation is no longer recruiting individuals for participation. The trial was first published on September 2nd 2022 and the last modification occurred November 8th 2022. Although this particular study has concluded recruitment efforts, 333 other trials are currently seeking participants."

Answered by AI

Does the population participating in this study include individuals under fifty years of age?

"This medical trial requires that eligible participants are between 18 and 65 years of age. There are also 46 studies for minors under the age of consent, as well as 164 trials dedicated to seniors older than 65."

Answered by AI

How many medical facilities are currently conducting this trial in the city?

"16 different medical centres are currently recruiting patients for this clinical trial. Individuals in Chicago, Miami Lakes and Atlanta have the closest options, although there is a selection of other cities providing access to this medication. It may be beneficial to pick the clinic nearest you if possible to limit travel distances."

Answered by AI

Am I eligible to enroll in this research endeavor?

"This medical trial is recruiting 850 participants with schizophrenia, aged between 18 and 65."

Answered by AI

Who else is applying?

What site did they apply to?
Culver City, California
Miami, Florida
Austin, Texas
Other
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
How many prior treatments have patients received?
1

How responsive is this trial?

Average response time
  • < 2 Days
Most responsive sites:
  1. Ascension Illinois Clinical Research: < 24 hours
  2. Miami, Florida: < 48 hours
  3. Keralty Hospital Miami: < 48 hours
Typically responds via
Email
Phone Call
Recent research and studies
clinicaltrials.govStudy
A Study to Evaluate Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia
2022. "A Study to Evaluate Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05443724.
All > Tandem > Schizophrenia
~204 spots leftby Nov 2024
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