Blood PressurePhase 1NCT05245539
Trial to Study the Effect of CVL-231 on 24-Hour Ambulatory Blood Pressure in Participants With Schizophrenia
A Phase 1 study testing CVL-231 in people with Blood Pressure and Schizophrenia, run by Cerevel Therapeutics, LLC at 10 sites in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 to 60 years
- Conditions the study is for
- Blood Pressure, Schizophrenia
- What is being tested?
- CVL-231
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 151 participants
- Where
- 10 sitesUnited States
- Study dates
- 24 Jan 2022to 14 Nov 2022
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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).
Who cannot join
- 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.
Show all 20Show fewer
- 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.
- 12-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)
- Abnormal heart rhythm (atrial fibrillation and atrial flutter)
- Blood pressure measurements demonstrating any of the following at the Screening Visit and at Check-in (Day -5):
- Systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg
- o Blood pressure will be measured in a seated position after at least 3 minutes of rest. The average of 3 measurements will be used to determine eligibility.
- Orthostatic hypotension, defined as a decrease of ≥20 mmHg in systolic blood pressure after at least 2 minutes of standing compared with the average of the resting supine blood pressure measurement
Trial locations and contacts
10 sites in 1 country.
10 sites in 1 country
United States10 sites
Community Clinical Research
Austin, Texas, 78754
Pillar Clinical Research LLC
Bentonville, Arkansas, 72712
Uptown Research Institute LLC
Chicago, Illinois, 60640
Pillar Clinical Research LLC
Lincolnwood, Illinois, 60712
Woodland International Research Group LLC - ERG - PPDS
Little Rock, Arkansas, 72211
Collaborative NeuroScience Research, LLC - Torrance - Apex - PPDS
Long Beach, California, 90806
Hassman Research Institute - Apex - PPDS
Marlton, New Jersey, 08053
Innovative Clinical Research, Inc - ClinEdge - PPDS
Miami, Florida, 33016
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, 44720
Pillar Clinical Research LLC
Richardson, Texas, 75080
About this study
Official title: A Randomized, Double-Blind Trial to Study the Effect of CVL-231 on 24-Hour Ambulatory Blood Pressure in Participants With Schizophrenia
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
- Being tested
- CVL-231
- Medical subject headings
- Schizophrenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CVL-231Drug
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.
| Study group | Role | What they receive |
|---|---|---|
| CVL-231 Dose Level 1 | Experimental | 10 mg once daily Receives: Drug: CVL-231 |
| CVL-231 Dose Level 2 | Experimental | 30 mg once daily Receives: Drug: CVL-231 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Mean change from Baseline to Week 8 in the 24-hour ambulatory SBP (Systolic Blood Pressure)
Measured: Baseline to week 8
Secondary outcomes (17)
Mean changes from Baseline to Weeks 4 and 8 in ambulatory SBP during daytime period
Measured: At weeks 4 and 8
Mean changes from Baseline to Weeks 4 and 8 in ambulatory SBP during nighttime period
Measured: At weeks 4 and 8
Mean change from Baseline to Week 4 in the 24-hour ambulatory SBP
Measured: At week 4
Mean change from Baseline to Weeks 4 and 8 in the 24-hour ambulatory DBP (Diastolic blood pressure)
Measured: At week 8
Mean change from Baseline to Weeks 4 and 8 in the 24-hour ambulatory HR (Heart rate)
Measured: At weeks 4 and 8
Number of treatment-emergent adverse events
Measured: Screening through day 84
Frequency of clinically significant changes in electrocardiograms
Measured: Baseline through day 84
Frequency of clinically significant changes in clinical laboratory assessments
Measured: Baseline through day 84
Frequency of clinically significant changes in vital sign measurements
Measured: Baseline through day 84
Frequency of clinically significant changes in physical examination results
Measured: Baseline through day 84
Frequency of clinically significant changes in neurological examination results
Measured: Baseline through day 84
Frequency of clinically significant findings in suicidality assessed using the C-SSRS (Columbia Suicide Severity Rating Scale)
Measured: Baseline through day 84
Frequency of clinically significant findings in extrapyramidal symptoms evaluated using the SAS (Simpson Angus Scale)
Measured: Baseline through day 84
Frequency of clinically significant findings in extrapyramidal symptoms evaluated using the AIMS (Abnormal Involuntary Movement Scale)
Measured: Baseline through day 84
Frequency of clinically significant findings in extrapyramidal symptoms evaluated using the BARS (Barnes Akathisia Rating Scale)
Measured: Baseline through day 84
Steady state CVL-231 Peak Plasma Concentration (Cmax) for CVL-231 and Metabolite (PF-06892787)
Measured: Baseline through day 84
Area under the plasma concentration-time curve over dosing interval (AUCτ) for CVL-231 and Metabolite (PF-06892787)
Measured: Baseline through day 84
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Feb 2022
- Study start24 Jan 2022
- Primary completion19 Oct 2022
- Study completion14 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Blood PressureStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 151 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cerevel Therapeutics, LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Erica Koenig, PhD, Study director, Cerevel Therapeutics, LLC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05245539
- Sponsor's protocol ID
- CVL-231-1005
- Status last verified
- Dec 2022
- First submitted
- 27 Jan 2022
- Last updated
- 14 Dec 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind Trial to Study the Effect of CVL-231 on 24-Hour Ambulatory Blood Pressure in Participants With Schizophrenia
- ClinicalTrials.gov ID
- NCT05245539
- Acronym / sponsor ID
- CVL-231-1005
- Conditions
- Blood Pressure, Schizophrenia
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 151 participants (actual)
- Lead sponsor
- Cerevel Therapeutics, LLCIndustry (pharma, biotech, devices)
- Study start
- 24 Jan 2022 (actual)
- Primary completion
- 19 Oct 2022 (actual)
- Study completion
- 14 Nov 2022 (actual)
- First posted
- 18 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CVL-231 Dose Level 1 | Experimental | Drug: CVL-23110 mg once daily |
| CVL-231 Dose Level 2 | Experimental | Drug: CVL-23130 mg once daily |
Who may qualify
- Ages
- 30 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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).
Key exclusion criteria (20 listed)
- 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:
- 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.
- 12-lead ECG demonstrating any of the following at the Screening Visit or at Check-in (Day -5):
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| CVL-231CVL-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. | Drug | CVL-231 Dose Level 1, CVL-231 Dose Level 2 |
Primary outcome
Mean change from Baseline to Week 8 in the 24-hour ambulatory SBP (Systolic Blood Pressure)
Time frame: Baseline to week 8
17 secondary outcomes
Mean changes from Baseline to Weeks 4 and 8 in ambulatory SBP during daytime period
Time frame: At weeks 4 and 8
Mean changes from Baseline to Weeks 4 and 8 in ambulatory SBP during nighttime period
Time frame: At weeks 4 and 8
Mean change from Baseline to Week 4 in the 24-hour ambulatory SBP
Time frame: At week 4
Mean change from Baseline to Weeks 4 and 8 in the 24-hour ambulatory DBP (Diastolic blood pressure)
Time frame: At week 8
Mean change from Baseline to Weeks 4 and 8 in the 24-hour ambulatory HR (Heart rate)
Time frame: At weeks 4 and 8
Number of treatment-emergent adverse events
Time frame: Screening through day 84
Frequency of clinically significant changes in electrocardiograms
Time frame: Baseline through day 84
Frequency of clinically significant changes in clinical laboratory assessments
Time frame: Baseline through day 84
Frequency of clinically significant changes in vital sign measurements
Time frame: Baseline through day 84
Frequency of clinically significant changes in physical examination results
Time frame: Baseline through day 84
Frequency of clinically significant changes in neurological examination results
Time frame: Baseline through day 84
Frequency of clinically significant findings in suicidality assessed using the C-SSRS (Columbia Suicide Severity Rating Scale)
Time frame: Baseline through day 84
Frequency of clinically significant findings in extrapyramidal symptoms evaluated using the SAS (Simpson Angus Scale)
Time frame: Baseline through day 84
Frequency of clinically significant findings in extrapyramidal symptoms evaluated using the AIMS (Abnormal Involuntary Movement Scale)
Time frame: Baseline through day 84
Frequency of clinically significant findings in extrapyramidal symptoms evaluated using the BARS (Barnes Akathisia Rating Scale)
Time frame: Baseline through day 84
Steady state CVL-231 Peak Plasma Concentration (Cmax) for CVL-231 and Metabolite (PF-06892787)
Time frame: Baseline through day 84
Area under the plasma concentration-time curve over dosing interval (AUCτ) for CVL-231 and Metabolite (PF-06892787)
Time frame: Baseline through day 84
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Dec 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Erica Koenig, PhD study director
Cerevel Therapeutics, LLC
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing CVL-231 in people with Blood Pressure and Schizophrenia, run by Cerevel Therapeutics, LLC at 10 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 20 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean change from Baseline to Week 8 in the 24-hour ambulatory SBP (Systolic Blood Pressure) (time frame: Baseline to week 8). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Dec 2022.