Status and phase
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Treatments
About
This is a Phase 3, 6-week, randomized, double-blind, placebo-controlled, multicenter, outpatient study in subjects with schizophrenia with an inadequate response to their current atypical antipsychotic treatment. The primary objective of the study is to assess the efficacy of adjunctive KarXT (a fixed dose combination of xanomeline and trospium chloride twice daily [BID]) versus placebo in the treatment of subjects with inadequately controlled symptoms of schizophrenia as measured by the Positive and Negative Syndrome Scale (PANSS) Total Score.
Enrollment
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Volunteers
Inclusion criteria
Exclusion criteria
Any primary DSM-5 disorder other than schizophrenia within 12 months before screening (confirmed using MINI version 7.0.2 at screening)
The subject has a history of moderate to severe substance use disorder (other than nicotine) within the past 12 months
Subject has a history of treatment-resistant schizophrenia defined as:
a. Failure to minimally respond to 2 adequate courses of antipsychotic drug (APD) pharmacotherapy Note: Failure to minimally respond is defined as persistence symptoms of moderate severity in 2 or more psychotic symptom domains or persistence of severe symptoms in 1 or more psychotic symptom domains despite adequate dose and duration (6 weeks or longer) of APD treatment.
History of symptom instability
a. > 3 psychiatric hospitalizations over the last 12 months or 2 over the last 6 months
Current APD is other than aripiprazole, risperidone, paliperidone, or their LAI versions, ziprasidone, lurasidone, or cariprazine
Subjects who are diagnosed with schizophreniform disorder or are experiencing their first treated episode of schizophrenia
Significant or severe medical conditions including pulmonary, cardiovascular, hepatic, renal, hematologic, gastrointestinal, endocrine, immunologic, dermatologic, neurologic, or oncologic disease or any other condition that, in the opinion of the Investigator, could jeopardize the safety of the subject or the validity of the study results
Subjects with human immunodeficiency virus (HIV), cirrhosis, biliary duct abnormalities, hepatobiliary carcinoma, and/or active hepatic viral infections as indicated by medical history, serologies or LFT results
History or high risk of urinary retention, gastric retention, or narrow-angle glaucoma as evaluated by the Investigator
History of irritable bowel syndrome (with or without constipation) or any serious constipation requiring treatment within the last 6 months
Risk for suicidal behavior during the study as determined by the Investigator's clinical assessment and/or C-SSRS as confirmed by the following:
Clinically significant abnormal finding on the physical examination, medical history, ECG, or clinical laboratory results at Screening
Urine toxicology screen is positive for phencyclidine, amphetamines, opiates, cocaine, or alcohol (clinically significant alcohol use in the opinion of the Investigator)
Subject is currently taking, or plans to take while in the study, any prohibited concomitant medication.
Pregnant, lactating, or less than 3 months postpartum
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 his/her ability to adhere to the protocol visit schedule or fulfill visit requirements
Positive test for coronavirus (COVID-19) within 2 weeks or at Screening
Subjects with extreme concerns relating to global pandemics, such as COVID-19, that would obscure ratings or be expected to disrupt adherence to trial procedures
Unable to taper and discontinue a concomitant medication that would preclude participation in the double-blind adjunctive treatment (e.g., cannot stop anticholinergic)
Subjects with prior exposure to KarXT
Subjects who experienced any adverse effects due to xanomeline or trospium
Subjects who received investigational product as part of a clinical trial within 3 months of Screening
Risk of violent or destructive behavior as per Investigator's judgment that would interfere with subject's participation
Current involuntary hospitalization or incarcerationor on parole/probation
For all male subjects only, any one of the following:
Primary purpose
Allocation
Interventional model
Masking
360 participants in 2 patient groups, including a placebo 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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