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 Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
151
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.
Pillar Clinical Research LLC
Bentonville, Arkansas, United States
Woodland International Research Group LLC - ERG - PPDS
Little Rock, Arkansas, United States
Collaborative NeuroScience Research, LLC - Torrance - Apex - PPDS
Long Beach, California, United States
Mean change from Baseline to Week 8 in the 24-hour ambulatory SBP (Systolic Blood Pressure)
Time frame: Baseline to week 8
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
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Innovative Clinical Research, Inc - ClinEdge - PPDS
Miami, Florida, United States
Uptown Research Institute LLC
Chicago, Illinois, United States
Pillar Clinical Research LLC
Lincolnwood, Illinois, United States
Hassman Research Institute - Apex - PPDS
Marlton, New Jersey, United States
Neuro-Behavioral Clinical Research, Inc.
North Canton, Ohio, United States
Community Clinical Research
Austin, Texas, United States
Pillar Clinical Research LLC
Richardson, Texas, United States
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