Galiz Research | Hialeah, FL
Status and phase
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About
This is a Phase 3, multicenter, 52-week, outpatient, open-label extension (OLE) study to evaluate the long-term safety and tolerability of adjunctive KarXT in subjects with schizophrenia with an inadequate response to their current antipsychotic treatment who previously completed the treatment period (Visit 8/Day 42 ± 3) of ARISE Study (KAR-012). The primary objective of the study is to assess the long-term safety and tolerability of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily [BID]) in subjects with schizophrenia.
Enrollment
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Inclusion criteria
Exclusion criteria
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:
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
Female subject is pregnant
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
Risk of violent or destructive behavior as per Investigator's judgement
Subjects participating in another investigational drug or device trial or planning on participating in another clinical trial during the study
History or high risk of urinary retention, gastric retention, or narrow angle glaucoma as evaluated by the Investigator
Subject is taking, or plans to take while in the study, any prohibited concomitant medication
For all male subjects only, any one of the following:
Primary purpose
Allocation
Interventional model
Masking
280 participants in 1 patient group
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Central trial contact
BMS Clinical Trials Contact Center www.BMSClinicalTrials.com; First line of the email MUST contain the NCT# and Site #.
Data sourced from clinicaltrials.gov
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