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

Study at a glance

From the registry record, last updated by the sponsor on 21 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title

A 52-week, Phase 2, Open-label Trial to Evaluate the Long-term Safety and Tolerability of CVL-231 (Emraclidine) in Adult Participants With Schizophrenia

ClinicalTrials.gov ID

NCT05443724

Acronym / sponsor ID

CVL-231-2003

Conditions

Schizophrenia

Keywords

Schizophrenia Spectrum and Other Psychotic Disorders, Mental Disorders

Phase

Phase 2

Study type

Interventional

Recruitment status

TerminatedReason stopped: The study was terminated due to business reasons, not safety reasons.

Enrolment

698 participants (actual)

Lead sponsor

AbbVieIndustry (pharma, biotech, devices)

Study start

1 Sep 2022 (actual)

Primary completion

25 Jun 2025 (actual)

Study completion

25 Jun 2025 (actual)

First posted

5 Jul 2022 (actual)

Results

Posted 21 Aug 2026

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Study design

Primary purpose

Treatment

Allocation

Not applicable

Intervention model

Single group

Masking

None (open label)

Number of arms

3

Who may qualify

Ages

18 to 65 years

Sex

All

Healthy volunteers

Not accepted

Age groups

Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Primary outcome

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

   Time frame: 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.

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

   Time frame: 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.

3. Number of Participants With Clinically Significant Changes in Body Weight

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

   Participants' body weights were measured and recorded.

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

   Time frame: 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.

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

   Time frame: 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.

6. Number of Participants With Clinically Significant Changes in Clinical Laboratory Values

   Time frame: 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.

7. Number of Participants With Clinically Significant Changes in Metabolic Parameter Values

   Time frame: 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.

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

   Time frame: 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).

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

   Time frame: 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.

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

    Time frame: 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.

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

    Time frame: 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.

Results and safety

Loading the posted results from ClinicalTrials.gov…

Research links

• Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2026.
• Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
• 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.

85 sites in 5 countries: see every site and its status.