A Study to Evaluate Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia

Number of Participants With Treatment Emergent Adverse Events (TEAEs) and Treatment Emergent Serious Adverse Events (TESAEs)

Timeframe: From first dose of study drug until 28 days following last dose of study drug (up to Week 56)

An adverse event (AE) is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment. The investigator assesses the relationship of each event to the use of study drug. A serious adverse event (SAE) is an event that results in death, is life-threatening, requires or prolongs hospitalization, results in a congenital anomaly, persistent or significant disability/incapacity or is an important medical event that, based on medical judgment, may jeopardize the participant and may require medical or surgical intervention to prevent any of the outcomes listed above. Treatment-emergent adverse events/treatment-emergent serious adverse events (TEAEs/TESAEs) are defined as any event that began or worsened in severity on or after the first dose of study drug.

Number of Participants With Out-of-Range Vital Signs Occurring Post-Baseline

Timeframe: Baseline; from first dose of study drug up to Week 52

Vital signs were obtained after the participant had been supine and at rest for 3 minutes and included systolic and diastolic blood pressure, heart rate, temperature, and respiratory rate.

Number of Participants With Clinically Significant Changes in Body Weight

Timeframe: Baseline; from first dose of study drug up to Week 52

Participants' body weights were measured and recorded.

Number of Participants With Post-Baseline Clinically Significant Physical Examinations and Neurological Examinations

Timeframe: Baseline; from first dose of study drug up to Week 52

The number of participants with clinically significant changes in physical and neurological examination results post-treatment was documented.

Number of Participants With Clinically Significant Post-Baseline Changes in Electrocardiogram (ECG) Values

Timeframe: Baseline; from first dose of study drug up to Week 52

12-lead electrocardiogram (ECG) recordings were obtained after the participant had been supine and at rest for at least 3 minutes.

Number of Participants With Clinically Significant Changes in Clinical Laboratory Values

Timeframe: Baseline; from first dose of study drug up to Week 52

Clinical laboratory tests were performed at scheduled study visits, and the investigator recorded any clinically significant changes.

Number of Participants With Clinically Significant Changes in Metabolic Parameter Values

Timeframe: Baseline; from first dose of study drug up to Week 52

Clinical laboratory tests were performed at scheduled study visits, and the investigator recorded any clinically significant changes in metabolic parameter values.

Number of Participants With Suicide-Related Treatment-Emergent Events Assessed Using the Columbia Suicide Severity Rating Scale (C-SSRS)

Timeframe: Baseline; from first dose of study drug up to Week 52

The C-SSRS rates an individual's degree of suicidal ideation (SI) on a scale, ranging from "wish to be dead" to "active suicidal ideation with specific plan and intent." The scale identifies SI severity and intensity, which may be indicative of an individual's intent to commit suicide. C-SSRS SI severity subscale ranges from 0 (no SI) to 5 (active SI with plan and intent).

Change From Baseline in Simpson Angus Scale (SAS) Total Score

Timeframe: Baseline; Weeks 4, 8, 12, 20, 26, 32, 38, 44, and 52

The SAS consists of a list of 10 symptoms of parkinsonism. Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms and a score of 4 representing a severe condition. The SAS total score is the sum of the scores for all 10 items. Baseline was defined as the last value obtained prior to initiation of study drug. Change from baseline for a given endpoint was defined as the value on a given Study Day (Time Point) minus the Baseline Value. Negative changes from Baseline indicate an improvement in symptoms.

Change From Baseline in Abnormal Involuntary Movement Scale (AIMS) Movement Rating Score

Timeframe: Baseline; Weeks 4, 8, 12, 20, 26, 32, 38, 44, and 52

The Abnormal Involuntary Movement Scale assessment consists of 10 items describing symptoms of dyskinesia. Facial and oral movements (items 1-4), extremity movements (items 5 and 6), and trunk movements (item 7) are observed unobtrusively while the participant is at rest, and the investigator also makes global judgments on the participant's dyskinesias (items 8-10). Each item is rated on a 5-point scale, with a score of 0 representing absence of symptoms (for item 10, no awareness), and a score of 4 indicating a severe condition (for item 10, awareness, severe distress). In addition, the AIMS includes 2 yes/no questions that address the participant's dental status. The AIMS Movement Rating Score is defined as the sum of individual scores from items 1-7, ranging from 0 to 28. A lower score indicates less severe or absent abnormal movements. A negative change in the mean from Baseline indicates improvement in the severity of abnormal involuntary movements.

Change From Baseline in Barnes Akathisia Rating Scale (BARS) Global Clinical Evaluation Score

Timeframe: Baseline; Weeks 4, 8, 12, 20, 26, 32, 38, 44, and 52

The BARS consists of 4 items related to akathisia. The fourth item, reported here, is the Global Clinical Evaluation Score. The Global Clinical Evaluation Score is evaluated using a 6-point scale, ranging from 0 to 5, with 0 representing absence of symptoms and a score of 5 representing severe akathisia. A negative change from baseline indicates an improvement in symptoms.