The purpose of this study is to evaluate the long-term safety and tolerability of Xanomeline and Trospium Chloride for the treatment of psychiatric disorders in children and adolescents
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
400
Number of participants with treatment emergent adverse events (TEAEs)
Time frame: Up to 56 weeks
Number of participants with adverse events of special interest (AESIs)
Time frame: Up to 56 weeks
Number of participants with serious adverse events (SAEs)
Time frame: Up to 56 weeks
Number or participants with cholinergic symptoms
Time frame: Up to 56 weeks
Number of participants with anticholinergic symptoms
Time frame: Up to 56 weeks
Number of participants with suicidal ideation and behavior assessed using the Columbia Suicide Severity Rating Scale (C-SSRS)
Time frame: Up to 56 weeks
Change from baseline on the Simpson-Angus Scale (SAS)
Time frame: Up to 52 weeks
Change from baseline on the Abnormal Involuntary Movement Scale (AIMS)
Time frame: Up to 52 weeks
Change from baseline on the Barnes-Akathisia Rating Scale (BARS)
Time frame: Up to 52 weeks
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CONTACT
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CONTACT
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