An Extension Study to Assess Long-Term Safety and Tolerability of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia

Exclusion Criteria

• •1. Risk for suicidal behavior during the study as determined by the Investigator's clinical assessment and/or Columbia-Suicide Severity Rating Scale (C-SSRS) as confirmed by the following:
• •1. Subject answers "Yes" to "suicidal ideation" Item 4 (active suicidal ideation with some intent to act, without a specific plan) or Item 5 (active suicidal ideation with a specific plan and intent) on the C-SSRS
• •2. Non-suicidal self-injurious behavior is not exclusionary
• •2. Any clinically significant abnormalities, including any finding(s) from ECG, or laboratory test at Visit 6, and the physical examination, vital signs, at the EOT visit of Study KAR-012 that the Investigator, in consultation with the Medical Monitor are considered to jeopardize the safety of the subject
• •3. Female subject is pregnant
• •4. If, in the opinion of the Investigator (and/or Sponsor/ Medical Monitor), subject is unsuitable for enrollment in the study or subject has any finding that, in the view of the Investigator (and/or Sponsor /Medical Monitor), may compromise the safety of the subject or affect their ability to adhere to the protocol visit schedule or study requirements
• •5. Risk of violent or destructive behavior as per Investigator's judgement
• •6. Subjects participating in another investigational drug or device trial or planning on participating in another clinical trial during the study
• •7. History or high risk of urinary retention, gastric retention, or narrow angle glaucoma as evaluated by the Investigator
• •8. Subject is taking, or plans to take while in the study, any prohibited concomitant medication
• •9. For all male subjects only, any one of the following:
• •1. History of bladder stones
• •2. History of recurrent urinary tract infections
• •3. Serum prostate specific antigen (PSA) \>10 ng/mL
• •4. An International Prostate Symptom Score (IPSS) of 5 (almost always) on either item 1, 3, 5, or 6
• •5. A sum of scores on IPSS items 1, 3, 5, and 6 of ≥9 Note: IPSS will be required only for male subjects ≥ 45 years of age. Subjects already enrolled in the study who do not have available PSA values from Study KAR-012 for baseline value use in Study CN012-0009, will have these assessments at their next clinic visit planned after re-consenting to determine current eligibility.