A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlle… (NCT05145413) | Clinical Trial Compass
CompletedPhase 3
A Study to Assess Efficacy and Safety of Adjunctive KarXT in Subjects With Inadequately Controlled Symptoms of Schizophrenia
United States396 participantsStarted 2021-11-12
Plain-language summary
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.
Who can participate
Age range18 Years – 65 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Subject is aged ≥18 to \<65 years at the time of randomization
✓. Subject is capable of providing signed Informed Consent Form before any study assessments will be performed
✓. Subject has a primary diagnosis of schizophrenia established by a comprehensive psychiatric evaluation based on the DSM-5 criteria and confirmed by Mini International Neuropsychiatric Interview for Schizophrenia and Psychotic Disorder Studies (MINI) version 7.0.2
✓. Subject is currently being treated with stable dosing of monotherapy risperidone, paliperidone, aripiprazole, or their LAIs ziprasidone, lurasidone, or cariprazine and has been taking this treatment with the same dosing regimen for at least 8 weeks at the time of Day 1 (Visit 3)
✓. The subject has had at least 1 previous inadequate response to above antipsychotics that was dosed appropriately (within the label) for at least 6 weeks
✓. The subject has not required psychiatric hospitalization, incarceration in prison, acute crisis intervention, or other increase in the level of care due to symptom exacerbation within 8 weeks of Screening and is psychiatrically stable in the opinion of the Investigator
✓. To be eligible for randomization, subjects need to have detectable levels of background antipsychotic medication (measured at Visit 1)
What they're measuring
1
Change From Baseline in Positive and Negative Syndrome Scale (PANSS) Total Score at Week 6
Timeframe: Baseline to Week 6
Trial details
NCT IDNCT05145413
SponsorKaruna Therapeutics, Inc., a Bristol Myers Squibb company
. Positive and Negative Syndrome Scale (PANSS) total score ≥ 70 at Screening and randomization
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
✕. A Screening subject with mild substance use disorder within the 12 months before Screening must be discussed with the Medical Monitor before being allowed into the study
✕. Subjects who test positive for cannabis at Screening may be permitted to enroll in consultation with the Medical Monitor if the subject's pattern of use is not indicative of a moderate to severe substance use disorder
✕. Subject has a history of treatment-resistant schizophrenia defined as:
✕. History of symptom instability
✕. 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