:
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.
Recruiting
