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Phase 3 Evaluation of KarXT and KarXT+KarX-EC in Schizophrenia and Autism-Related Irritability in Youth, respectively.
EU CTIS ID: 2025-524062-16-00
What this study is testing
To assess the long-term safety and tolerability of KarXT in the treatment of teenagers (13-17 years old) with schizophrenia and of KarXT+KarX-EC in the treatment of children and teenagers (5-17 years old) with irritability associated with ASD.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Teenagers with schizophrenia must be between 13-17 years old at the time of consent in study CN0120020, have a diagnosis of schizophrenia, and have completed the double-blind treatment period (i.e., Visit 8) of study CN0120020 without an adverse event that the study doctor believes is an unacceptable safety risk.
- Children and teenagers with irritability associated with ASD must be between 5-17 years old at the time of consent in studies CN0120044/CN0120045, have a diagnosis of ASD, and have completed the double-blind treatment period (i.e., Week 8) of study CN0120044 or CN0120045 without an adverse event that the study doctor believes is an unacceptable safety risk.
You likely can't join if
- Participants from study CN0120020 who have a primary diagnosis other than schizophrenia.
- Participants from study CN0120020 who are experiencing moderate to severe substance use disorder within the last year.
- Participants who, at the final end‑of‑treatment visit of Study CN0120020, Study CN0120044, or Study CN0120045 have any clinically significant abnormalities in physical examination, electrocardiogram, or vital signs (including heart rate or blood pressure) that, in the investigator’s judgment, could compromise their safety.
- Pregnant or breastfeeding women.
- Participants from Study CN0120044 and Study CN0120045 who have any primary psychiatric diagnosis other than ASD.
The study team makes the final eligibility decision.
Where it's taking place
- United States
- Colombia
- Argentina
- Japan
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 - 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, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United States; Colombia; Argentina; Japan. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.