Schizophrenia study: KarXT vs KarX-EC
Official title A Study to Evaluate the Long-term Safety and Tolerability of Xanomeline and Trospium Chloride for the Treatment of Psychiatric Disorders in Children and Adolescents
ClinicalTrials.gov ID: NCT07424404
What this study is testing
What is KarXT?
KarXT is an investigational medicine being studied for schizophrenia. KarXT is designed to target specific receptors in the brain to help regulate mood and thoughts.
Also referred to as Xanomeline/Trospium chloride.
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
- The study aims to see how safe and well‑tolerated these medicines are over a long period.
- Who it's for
- Children and adolescents who have schizophrenia or autism‑related irritability.
- What's involved
- Participants will take the study drugs and attend scheduled visits for medical checks and tests.
- Phase 3: a large, late-stage study
- This is a blinded study.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 5 to 17
You may be able to join if
- Participants must have completed the blinded treatment period (ie, Visit 8) of Study CN0120020 or the blinded treatment period (ie, Week 8) of Study...
- De-novo participants must have confirmed diagnosis of ASD with symptoms of irritability, as defined by the Diagnostic and Statistical Manual of...
You likely can't join if
- Participants must not have a significant risk of committing violent acts, serious self-harm, or attempting suicide based on history or routine...
- Participants must not have any clinically significant abnormality including any finding(s) from the physical examination, vital signs, or ECG at the...
- Participants must not have either a systolic blood pressure (sBP) or diastolic blood pressure (dBP) meeting criteria for stage 2 hypertension (HTN)...
- Other protocol-defined Inclusion/Exclusion criteria apply.
The study team makes the final eligibility decision.
Where it is enrolling
- Anaheim, California, United States
- Chino, California, United States
- Culver City, California, United States
- San Francisco, California, United States
- Hollywood, Florida, United States
- Orlando, Florida, United States
- Atlanta, Georgia, United States
- Lawrenceville, Georgia, United States
- Stone Mountain, Georgia, United States
- Chicago, Illinois, United States
- Boston, Massachusetts, United States
- Cincinnati, Ohio, United States
- Garland, Texas, United States
- Houston, Texas, United States
- Sapporo, Hokkaido, Japan
- Zentsujichó, Kagawa-ken, Japan
- Bunkyo-ku, Tokyo, Japan
- Ōta-ku, Tokyo, Japan
- Bucharest, Romania
- Cluj-Napoca, Romania
+ 1 more site(s).
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, 5 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Anaheim, California, United States; Chino, California, United States; Culver City, California, United States; San Francisco, California, United States; Hollywood, Florida, United States; Orlando, Florida, United States and 15 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.