At a glance
- What the study gets you
- Access to the study treatment being tested
- Type of study
- Interventional (receives a drug or procedure)
- Time in hospital
- In-person visits at study sites — visit count not specified by the sponsor
- Drug or intervention
- Xanomeline and Trospium Chloride Capsules (drug)
- How long the study runs
- Study runs about 48 months (dates as stated)
- About the drug or intervention
- Xanomeline and Trospium Chloride Capsules — drug: KarXT 50 mg/20 mg BID KarXT 75mg/20 mg BID KarXT 100mg/20 mg BID KarXT 125mg/30 mg BID
- Patient visit burden
- Not specified by the sponsor
- Type of study
- Testing a treatment
- Ages
- 18 Years to 65 Years
- Who
- All
- Number of participants
- 290
- Started
- 2022-03-07
- Last checked
- 2026-07
Plain English Summary
What is this study?
- • Testing a new treatment for schizophrenia
- • Phase3 - 290 participants
- • 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)
Who can take part?
- • Ages 18 Years to 65 Years
- • Diagnosed with schizophrenia
Where?
- • No UK sites listed for this trial
This is a simplified summary. Always discuss with your doctor before making any decisions.
About This Trial
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.
How this trial compares with your answers
Answer 2 more questions to improve match
What we know so far
Still need:
- • Tell us your age for better matching
- • Tell us your sex for better matching
Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.
Eligibility at a Glance
Key info
- Age: 18 Years - 65 Years
- Who can join: All genders
Biomarkers mentioned
What the study is looking for
- ✓Subject is aged ≥18 to \<66 years at the time of randomization of Study KAR-012
- ✓Subject has successfully completed the treatment period of Study KAR-012
- ✓Subject has been compliant with the procedures in Study KAR-012 (in the Investigator's judgement)
- ✓Subject is capable of providing signed agreement to take part Form before any study assessments will be performed
- ✓Subject resides in a stable living situation, in the opinion of the Investigator
Who cannot take part
- ✗Risk for suicidal behavior during the study as determined by the Investigator's clinical assessment and/or...
- ✗Non-suicidal self-injurious behavior is not exclusionary
- ✗Female subject is pregnant
- ✗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...
