CVL-231 30 mg for Schizophrenia

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Richardson, Texas, Richardson, TX
Schizophrenia
CVL-231 30 mg - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial will study the long-term effects of a new drug, emraclidine, on people with schizophrenia. CVL-231 30 mg is used to treat Schizophrenia and has previously been approved by the FDA for a different condition. No patients in this trial will receive a placebo.

Treatment Effectiveness

Study Objectives

11 Primary · 0 Secondary · Reporting Duration: Up to Week 56

Week 52
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
Up to Week 52
Number of Participants With Clinically Significant Change in Columbia Suicide Severity Rating Scale (C-SSRS) Score
Number of Participants With Clinically Significant Changes in Body Weight
Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
Number of Participants With Clinically Significant Changes in Electrocardiogram (ECG) Values
Number of Participants With Clinically Significant Changes in Metabolic Parameter Values
Number of Participants With Clinically Significant Changes in Physical and Neurological Examination Results
Number of Participants With Clinically Significant Changes in Vital Sign Values
Up to Week 56
Number of Participants With Treatment Emergent Adverse Events (TEAEs)

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

1 Treatment Group

CVL-231 30 mg
1 of 1
Experimental Treatment

850 Total Participants · 1 Treatment Group

Primary Treatment: CVL-231 30 mg · No Placebo Group · Phase 2

CVL-231 30 mg
Drug
Experimental Group · 1 Intervention: CVL-231 30 mg · Intervention Types: Drug

Trial Logistics

Trial Timeline

Approximate Timeline
Screening: ~3 weeks
Treatment: Varies
Reporting: up to week 56
Closest Location: Richardson, Texas · Richardson, TX
Photo of texas 1Photo of texas 2Photo of texas 3
N/AFirst Recorded Clinical Trial
2 TrialsResearching Schizophrenia
0 CompletedClinical Trials

Who is running the clinical trial?

Cerevel Therapeutics, LLCLead Sponsor
23 Previous Clinical Trials
3,500 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

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “yes” if the following statements are true for you:
You have a primary diagnosis of schizophrenia per the DSM-5.
You have been stable on antipsychotic medication for at least one year prior to screening.
You are willing to discontinue all prohibited medications to meet protocol-required washouts prior to and during the trial period.
You are able to understand the nature of the trial, participate in trial visits, and comply with protocol requirements.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 9th, 2021

Last Reviewed: August 12th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.