Schizophrenia study: Xanomeline/Trospium Chloride
Official title Relapse Prevention Trial Evaluating KarXT Treatment in Schizophrenia
ClinicalTrials.gov ID: NCT07686263
What this study is testing
What is Xanomeline/Trospium Chloride?
This is an investigational medicine being studied to help prevent relapse in people with schizophrenia. It is designed to work by affecting specific chemical signals in the brain called muscarinic receptors.
Also referred to as KarXT.
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This study is testing whether KarXT helps prevent relapse. It looks at how well it works for people with schizophrenia.
- Who it's for
- You may be able to join if you have schizophrenia.
- What's involved
- You would take KarXT to help prevent your symptoms from returning.
- Time commitment
- The source text does not say how long the study lasts or what visits are needed.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65
You may be able to join if
- Participant must have a primary diagnosis of schizophrenia for at least 1 year established by a comprehensive psychiatric evaluation based on the...
- 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.
- Item 1 (P1; delusions)
- Item 2 (P2; conceptual disorganization)
You likely can't join if
- 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...
- 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%.
See the full eligibility 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...
- 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.
- Item 1 (P1; delusions)
- Item 2 (P2; conceptual disorganization)
- Item 3 (P3; hallucinatory behavior)
- 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.
- 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.
The study team makes the final eligibility decision.
Where it is enrolling
- Bentonville, Arkansas, United States
- Little Rock, Arkansas, United States
- Bellflower, California, United States
- Garden Grove, California, United States
- Orange, California, United States
- Boynton Beach, Florida, United States
- Hollywood, Florida, United States
- Atlanta, Georgia, United States
- Chicago, Illinois, United States
- Richardson, Texas, United States
- Santiago del Estero, Argentina
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Bentonville, Arkansas, United States; Little Rock, Arkansas, United States; Bellflower, California, United States; Garden Grove, California, United States; Orange, California, United States; Boynton Beach, Florida, United States and 5 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.