Trial to Study the Effect of CVL-231 on 24-Hour Ambulatory Blood Pressure in Participants With Schizophrenia

NCT05245539 | Completed Phase 1 FDA Drug

• 1 other identifier: CVL-231-1005
• Study Type: interventional
• Target: 151
• Locations: 1 country
• Sites: 10

Brief Summary

The purpose of this trial is to characterize the effects of 2 oral doses (over 8 weeks total) of CVL-231 on ambulatory blood pressure and heart rate in patients with stable schizophrenia.

Conditions

Blood Pressure; Schizophrenia

Outcome Measures

Primary Outcomes (1)

• Mean change from Baseline to Week 8 in the 24-hour ambulatory SBP (Systolic Blood Pressure)

  Baseline to week 8

Secondary Outcomes (17)

• Mean changes from Baseline to Weeks 4 and 8 in ambulatory SBP during daytime period

  At weeks 4 and 8

• Mean changes from Baseline to Weeks 4 and 8 in ambulatory SBP during nighttime period

  At weeks 4 and 8

• Mean change from Baseline to Week 4 in the 24-hour ambulatory SBP

  At week 4

• Mean change from Baseline to Weeks 4 and 8 in the 24-hour ambulatory DBP (Diastolic blood pressure)

  At week 8

• Mean change from Baseline to Weeks 4 and 8 in the 24-hour ambulatory HR (Heart rate)

  At weeks 4 and 8

Study Arms (2)

CVL-231 Dose Level 1

EXPERIMENTAL

10 mg once daily

Drug: CVL-231

CVL-231 Dose Level 2

EXPERIMENTAL

30 mg once daily

Drug: CVL-231

Interventions

CVL-231 DRUG

CVL-231 is a brain penetrant mAChR activator that selectively binds to the M4 mAChR subtype while sparing other muscarinic receptor subtypes (M1, M2, M3, and M5). CVL-231 is being developed for treatment of psychosis in schizophrenia.

CVL-231 Dose Level 1; CVL-231 Dose Level 2

Eligibility Criteria

• Age: 30 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Male and female participants, ages 30 to 60 years, inclusive, at the time of signing the ICF.
• Primary diagnosis of schizophrenia per DSM-5, as confirmed by the MINI version 7.0.2.
• PANSS Total Score ≤70 at the time of signing the ICF and Check-in (Day -5).

You may not qualify if:

• Current DSM-5 diagnosis other than schizophrenia including, but not limited to, mental retardation; schizoaffective disorder; major depressive disorder; schizophreniform disorder; psychotic depression; bipolar disorder; post-traumatic stress disorder; generalized anxiety disorder, obsessive compulsive disorder, eating disorders (bulimia, anorexia), or other anxiety disorders as a primary diagnosis (Note: Anxiety symptoms secondary to schizophrenia are allowed); delirium, dementia, amnestic, or other cognitive disorders. Acute depressive symptoms within 30 days prior to signing the ICF that require treatment with an antidepressant are exclusory. Additional excluded conditions include borderline, paranoid, histrionic, schizotypal, schizoid, or antisocial personality disorder.
• Any of the following:
• Schizophrenia considered resistant/refractory (defined as failure to respond to 2 or more courses of adequate pharmacological treatment) to antipsychotic treatment by history
• History of failure to respond to clozapine
• Response to clozapine treatment only
• History of extrapyramidal symptoms treated with a medication that required dose modification and/or new treatment within 6 months prior to signing the ICF.
• Current or past history of significant cardiovascular disease including any of the following: ischemic heart disease, myocardial infarction, cardiac valvulopathy, cardiac surgery revascularization (coronary artery bypass grafting) or stenting or percutaneous transluminal coronary angioplasty), hypertension, receiving medications to treat hypertension, orthostatic hypotension, angina, unstable angina, cerebrovascular accident or stroke or transient ischemic attack, pacemaker, atrial fibrillation, atrial flutter, paroxysmal atrial tachycardia, or non-sustained or sustained ventricular tachycardia, pulmonary arterial hypertension, sick sinus syndrome, Type 2 second-degree or third-degree atrioventricular block, congestive heart failure, personal or family history of sudden death or long QT syndrome, unexplained syncope or syncope within the last 3 years regardless of etiology.
• lead ECG demonstrating any of the following at the Screening Visit or at Check-in (Day -5):
• QTcF interval \>450 ms
• QRS interval \>120 ms (unless right bundle branch block)
• PR interval \>200 ms
• LVH with ST depressions and/or T wave inversions in leads with relatively tall R waves (ie, LVH with associated ST-T wave abnormalities)
• Type 2 second-degree or third-degree atrioventricular block
• Heart rate \<45 bpm or \>90 bpm
• Abnormal acute ECG changes (such as clinically significant ST depression or elevation or T wave inversion)

Sponsors & Collaborators

• Cerevel Therapeutics, LLC: lead

Study Sites (10)

Pillar Clinical Research LLC

Bentonville, Arkansas, 72712, United States

Location

Woodland International Research Group LLC - ERG - PPDS

Little Rock, Arkansas, 72211, United States

Location

Collaborative NeuroScience Research, LLC - Torrance - Apex - PPDS

Long Beach, California, 90806, United States

Location

Innovative Clinical Research, Inc - ClinEdge - PPDS

Miami, Florida, 33016, United States

Location

Uptown Research Institute LLC

Chicago, Illinois, 60640, United States

Location

Pillar Clinical Research LLC

Lincolnwood, Illinois, 60712, United States

Location

Hassman Research Institute - Apex - PPDS

Marlton, New Jersey, 08053, United States

Location

Neuro-Behavioral Clinical Research, Inc.

North Canton, Ohio, 44720, United States

Location

Community Clinical Research

Austin, Texas, 78754, United States

Location

Pillar Clinical Research LLC

Richardson, Texas, 75080, United States

Location

MeSH Terms

Conditions

Schizophrenia

Condition Hierarchy (Ancestors)

Schizophrenia Spectrum and Other Psychotic Disorders; Mental Disorders

Study Officials

• Erica Koenig, PhD

  Cerevel Therapeutics, LLC

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 18, 2022
• Study Start: January 24, 2022
• Primary Completion: October 19, 2022
• Study Completion: November 14, 2022
• Last Updated: December 14, 2022

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (10)