RecruitingPHASE3INTERVENTIONAL

A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively

This study is for young people aged 5 to 17 who are already taking KarXT or KarX-EC for schizophrenia or irritability related to autism. It’s part of a bigger research effort to understand these conditions better. The main goal is to carefully watch how safe the medicine is and if people can tolerate it well over a longer period. This is a "Phase 3" study, meaning the medicine has already gone through earlier tests and shown promise. By carefully tracking participants, researchers hope to gather more information to help future patients. Only those who have completed an earlier part of this research without serious issues can join this specific long-term study.

At a glance

Status

Recruiting

Phase

PHASE3

Sponsor

Karuna Therapeutics, Inc., a Bristol Myers Squibb company

Enrolment target

400

Start

07 Apr 2026

Estimated completion

08 Mar 2030

Schizophrenia Autism-Related Irritability

What is this study about?

This research study is looking at a medicine called KarXT. It's designed for young people aged 5 to 17 who are living with schizophrenia or experiencing irritability related to autism. Schizophrenia is a serious mental health condition that affects how a person thinks, feels, and behaves. Irritability in autism can be a significant challenge for individuals and their families. The study aims to make sure the medicine is safe and easy for young people to take over a longer period of time.

This study is called a "Phase 3" study. This means that the medicine has already been tested in earlier stages and has shown some positive effects. Now, researchers need to gather more information on its long-term safety and how well people tolerate it. By understand these aspects, doctors can make better decisions about how to help young people with these conditions in the future.

Taking part in this study means you would be contributing important information that could help many others. The research team will be carefully monitoring participants to ensure their well-being and to collect vital data about the medicine's effects over time. This type of research is crucial for developing new and better treatments.

Key takeaways

This study is testing the long-term safety of a medicine called KarXT for young people.
It's for those aged 5 to 17 with schizophrenia or autism-related irritability.
Only participants who finished an earlier part of the study can join this one.
The study aims to gather important information to help future patients.
Your health will be carefully monitored throughout your participation.

Who may be eligible?

To be part of this study, young people must have already finished a specific earlier part of this research, without having had any serious side effects that an expert thought were too risky.

There are some reasons why someone might not be able to join. For example, if there's a high risk of violent behaviour, serious self-harm, or suicide, then they wouldn't be able to take part. Also, if a doctor finds any other significant health problems during a check-up that could put the person's safety at risk, they wouldn't be eligible.

Additionally, young people with very high blood pressure (which is called Stage 2 hypertension) cannot participate. The research team will carefully review everyone's health and medical history to make sure it's safe for them to join.

Could this study suit you?

Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.

Are you aged between 5 and 17 years old?
Have you already completed an earlier part of the KarXT research study (like CN0120020, CN0120044, or CN0120045)?
Have you not had any serious side effects from the study medicine before that a doctor thought were too risky?
Do you feel that you do not have a high risk of violent acts, serious self-harm, or suicide?
Do you not have very high blood pressure (Stage 2 hypertension)?

Answer every question to see your result.

What does participation involve?

This study is an extension study, meaning it's for people who have already completed an initial part of the research (studies CN0120020, CN0120044, or CN0120045). If you join, you would continue to receive the study medicine, KarXT or KarX-EC, as directed by the study doctors. You would have regular visits to the clinic so the research team can monitor your health, how you're feeling, and how the medicine is affecting you. These visits will involve health checks, blood pressure measurements, and discussions about any side effects. The exact number and frequency of visits, along with the total duration of your participation, would be explained in full by the study team. You would also have check-ups to make sure the medicine is still suitable for you. All participants will be supervised by medical professionals throughout the study.

Potential risks and benefits

While participating in this study could potentially help you manage your condition, the main aim is to gather more information about the medicine's long-term safety, which might benefit others in the future. As with any medicine, there's always a chance of side effects, which the study team will discuss in detail with you. They will carefully monitor you for any potential risks throughout your participation. You are always free to withdraw from the study at any time, for any reason, without it affecting your medical care.

Locations (59)

Local Institution - 0077
Verified postcode
Anaheim, United States· Not yet recruiting
Local Institution - 0058
Verified postcode
Chino, United States· Not yet recruiting
Local Institution - 0024
Verified postcode
Culver City, United States· Not yet recruiting
Local Institution - 0083
Verified postcode
Redlands, United States· Not yet recruiting
Local Institution - 0089
Verified postcode
San Francisco, United States· Not yet recruiting
Apg Research, Llc
Verified postcode
Orlando, United States· Recruiting
Atlanta Center for Medical Research
Verified postcode
Atlanta, United States· Recruiting
Salveo Integrative Health - Lawrenceville
Verified postcode
Lawrenceville, United States· Recruiting
Local Institution - 0039
Verified postcode
Stone Mountain, United States· Not yet recruiting
EmVenio Research Center - Prime Healthcare
Verified postcode
Chicago, United States· Recruiting
Local Institution - 0076
Verified postcode
Boston, United States· Not yet recruiting
Local Institution - 0059
Verified postcode
Worcester, United States· Not yet recruiting

Common questions

What is KarXT?

KarXT is a medicine being studied for conditions like schizophrenia and irritability linked to autism in young people.

Who can join this study?

This study is for young people aged 5 to 17 who have already completed an earlier phase of this research without significant problems.

What is a 'Phase 3' study?

A Phase 3 study checks the safety and effectiveness of a new medicine in a larger group of people, after it has shown promise in earlier tests.

Will I get the study medicine if I join?

Yes, if you meet the criteria and join, you would continue to receive the study medicine, KarXT or KarX-EC.

Can I stop being part of the study at any time?

Yes, you are completely free to leave the study at any point, and your regular medical care will not be affected.

How to find out more

BMS Clinical Trials Contact Center www.BMSClinicalTrials.com

clinical.trials@bms.com 855-907-3286 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.