Not yet recruitingPHASE3INTERVENTIONAL

A Study of KarXT + KarX-EC for Treatment of Irritability in Children and Adolescents With Autism Spectrum Disorder

This research study is investigating a new treatment for irritability in children and teenagers with autism. The treatment involves a combination of two medications, KarXT and KarX-EC. Irritability can be a challenging symptom for individuals with autism, affecting their daily lives and well-being. This study aims to find out if this specific combination of medications is safe and effective in reducing these irritable feelings. Participants will be given either the new medication combination or a placebo (a dummy pill with no active medicine) to compare their effects. This is a Phase 3 study, meaning it's one of the final steps before a medicine might be approved for wider use.

At a glance

Status

Not yet recruiting

Phase

PHASE3

Sponsor

Bristol-Myers Squibb

Enrolment target

176

Start

11 Sep 2026

Estimated completion

04 Aug 2029

Irritability Associated With Autism Spectrum Disorder

What is this study about?

This research is looking into a new way to help children and teenagers aged 5 to 17 who have autism and experience significant irritability. Irritability can mean things like having frequent tantrums, getting very upset, or being easily frustrated. These feelings can be difficult for young people and their families, impacting their daily lives at home and school. The study wants to see if a combination of two medications, called KarXT and KarX-EC, can help manage these symptoms.

The medications being tested are designed to work on certain brain pathways that might be involved in irritability. By taking part in the study, participants will help doctors understand more about how these medications work and if they are a safe and effective option. This is important because finding better ways to manage irritability can improve the quality of life for young people with autism.

This is a 'Phase 3' study, which means it’s one of the final stages of testing a new medicine. Before a new medicine can be used more widely, it needs to be carefully studied in many people to make sure it's safe and that it works as intended. Your participation could contribute to new treatment options for many other children and teenagers with autism in the future.

Key takeaways

This study evaluates a new medication (KarXT + KarX-EC) for irritability in children and teens with autism.
It aims to find out if the new treatment is safe and effective.
Participants will receive either the new medication or a placebo.
The study involves regular visits and health checks.
Participation could help develop new treatments for autism-related irritability.
You can stop participating at any time.

Who may be eligible?

To join this study, children and teenagers must be between 5 and 17 years old and have an official diagnosis of autism. They also need to be experiencing noticeable irritability, which medical staff will measure using specific questionnaires and ratings.

There are also some reasons why someone might not be able to join. For example, if they have other serious mental health conditions like bipolar disorder or schizophrenia, they wouldn't be eligible. However, if a child also has ADHD (attention deficit/hyperactivity disorder) and it's well-managed and stable, they might still be able to take part.

It's also important that participants don't have any major medical illnesses that could put them at risk, or problems with their blood test results. The doctors will check for any risk of suicidal thoughts. There might be some other specific rules depending on the study, which the medical team will explain.

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.

Is your child aged between 5 and 17 years old?
Does your child have an official diagnosis of autism?
Does your child experience significant irritability?
Does your child *not* have other major mental health conditions like bipolar disorder or schizophrenia?
Is your child's overall health stable?
Are there no immediate concerns about your child's safety or suicidal thoughts?

Answer every question to see your result.

What does participation involve?

If you decide to take part, your child will be given either the new medication combination (KarXT + KarX-EC) or a placebo (a dummy pill with no medicine). You won't know which one they are receiving. Your child will have regular visits to the clinic where doctors and nurses will do assessments to see how they are feeling and if the medication is helping with irritability. These assessments will involve discussions and questionnaires. They will also have physical checks and blood tests to make sure they are safe. Throughout the study, your child will be carefully monitored. The total duration of participation, including all follow-up appointments, will be clearly explained by the study team.

Potential risks and benefits

Participating in a clinical trial may offer potential benefits, such as access to a new experimental treatment that might help with irritability, and contributing to medical research to help others in the future. However, there are also potential risks, including side effects from the medication (whether it's the active drug or the placebo), and the time commitment for appointments. We don't yet know all the side effects of this new drug. You will be closely monitored, and you have the right to withdraw your child from the study at any time, for any reason, without it affecting their regular medical care.

Locations (55)

Local Institution - 0062
Verified postcode
Phoenix, United States
Local Institution - 0001
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Bentonville, United States
Local Institution - 0013
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Glendale, United States
Local Institution - 0117
Verified postcode
Los Angeles, United States
Local Institution - 0126
Verified postcode
Orange, United States
Local Institution - 0115
Verified postcode
San Juan Capistrano, United States
Local Institution - 0116
Verified postcode
San Rafael, United States
Local Institution - 0080
Verified postcode
Orlando, United States
Local Institution - 0014
Verified postcode
Chicago, United States
Local Institution - 0006
Verified postcode
Lexington, United States
Local Institution - 0051
Verified postcode
Lexington, United States
Local Institution - 0016
Verified postcode
Columbia, United States

Common questions

What is KarXT + KarX-EC?

It's a combination of two new medications being tested to see if they can help reduce irritability in young people with autism.

What is a 'placebo'?

A placebo is a dummy pill that looks like the study medication but contains no active ingredients. It's used to compare against the real medicine.

Will we know if my child is getting the real medicine or the placebo?

No, neither you nor the study team will know during the study. This helps ensure fair results.

What happens if we want to stop participating?

You can withdraw your child from the study at any time, for any reason, and it won't affect their usual medical care.

How long will the study last?

The study team will tell you the exact duration of your child's participation, including all visits and follow-up.

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.