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Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia

RecruitingPhase 3Ages 18 Years - 65 YearsAllKaruna Therapeutics, Inc., a Bristol Myers Squibb…
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In plain words

What the trial is, and whether it could suit you

The purpose of the study is to evaluate the relapse prevention of KarXT in the treatment of participants with Schizophrenia

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria * Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the DSM-5-TR (American Psychiatric Association 2022) criteria and confirmed by MINI for Psychotic Disorder Studies version 7.0.2 at screening. * Participant must have experienced hospitalization for schizophrenia within 1 year from the screening date. * Participant must be experiencing residual schizophrenia symptoms and have a PANSS total score ≥70 to ≤ 110 at screening and Day -1. * Participant much have a PANSS Score of ≥ 4 (moderate or greater) on ≥ 2 of the following Positive Scale (P) items at screening and Day -1: 1. Item 1 (P1; delusions) 2. Item 2 (P2; conceptual disorganization) 3. Item 3 (P3; hallucinatory behavior) 4. Item 6 (P6; suspiciousness/persecution) * Participant must have a CGI-S score of ≥ 4 at screening and Day -1 * Participant must have a BMI ≥ 18 and ≤ 40 kg/m2. Exclusion Criteria * Participant must not have any primary DSM-5 disorder other than schizophrenia within 12 months before screening * Participants must not have a newly diagnosed or are experiencing their first treated episode of psychosis or schizophrenia. * Participant must not have a risk of suicidal behavior as determined by the Investigator's clinical assessment and/or Columbia-suicide Severity Rating Scale (C-SSRS). * Participant must not have had psychiatric hospitalization(s) for more than 30 days (cumulative) within the 6 months before screening. * Participant must not have a history of treatment resistance to schizophrenia medications * Participant must not have decrease in PANSS total score (floor adjusted) between screening and Day -1 of more than 20%. * Other protocol-defined Inclusion/Exclusion criteria apply.
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What it tests

  • Xanomeline/Trospium Chloride
  • Placebo
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Where

59 sites
Pillar Clinical Research - Bentonville
Bentonville, United States
Pillar Clinical Research- Little Rock
Little Rock, United States
Local Institution - 0021
Little Rock, United States
Local Institution - 0153
Rogers, United States
Local Institution - 0190
Anaheim, United States
Local Institution - 0040
Bellflower, United States
Local Institution - 0188
Chino, United States
Local Institution - 0032
Culver City, United States

…and 51 more on ClinicalTrials.gov.

🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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