AuthorisedTherapeutic confirmatory (Phase III)Interventional

A Phase 3 Multicenter, Open-label Study to Assess the Long-term Safety and Tolerability of KarXT in Adolescents (13 to 17 years of age) with Schizophrenia and KarXT+KarX-EC in Children and Adolescents (5 to 17 years of age) with Irritability Associated with Autism Spectrum Disorder

This research is looking into new medicines called KarXT and KarX-EC. We want to see how safe these medicines are for young people. Specifically, we're studying KarXT in teenagers (13-17 years old) who have schizophrenia. We're also looking at KarXT and KarX-EC in children and teenagers (5-17 years old) who have autism and experience a lot of irritability. The main goal is to carefully watch for any side effects or problems that might happen while taking these medicines and for a period after. This helps us understand if these treatments are safe for long-term use in young people with these conditions, without making any medical recommendations.

At a glance

Status

Authorised

Phase

Therapeutic confirmatory (Phase III)

Sponsor

Bristol-Myers Squibb Services Unlimited Company

Enrolment target

Start

29 May 2026

Schizophrenia and Autism Spectrum Disorder (ASD)

What is this study about?

This is a very important study designed to understand more about new medicines called KarXT and KarX-EC. The main purpose is to see how safe these medicines are when given to young people over a longer time. We know that conditions like schizophrenia and autism can be really challenging for young people and their families, and finding effective and safe treatments is a top priority.

In this study, one group of teenagers (aged 13 to 17) with schizophrenia will be given KarXT. Another group, consisting of children and teenagers (aged 5 to 17) who have autism and struggle with irritability, will receive either KarXT or KarX-EC. By monitoring them closely, we want to identify any side effects that might come up, whether they are minor or more serious. This helps doctors decide if these new medicines could be a good option in the future for treating these conditions in young people.

The information we gather about safety is incredibly valuable. It helps us build a full picture of how these medicines work in younger people, as their bodies can react differently to medicines compared to adults. This kind of research is essential for developing better and safer treatments for young people with these conditions, and it moves us a step closer to understanding how we can improve their quality of life.

Key takeaways

This study is testing new medicines (KarXT, KarX-EC) for safety in young people.
It's for teenagers with schizophrenia (13-17) and children/teenagers with autism-related irritability (5-17).
The main aim is to identify any side effects or health problems that occur.
Participation involves regular visits and health checks over time.
It could offer access to new potential treatments under close medical supervision.

Who may be eligible?

This study is open to both boys and girls. For schizophrenia, we are looking for teenagers aged 13 to 17 years old. For irritability linked to autism, we are looking for children and teenagers aged 5 to 17 years old.

There usually are other specific requirements that aren't mentioned here, such as health checks or whether the young person is already taking certain medicines. These details are important to make sure the study is safe and right for each participant.

If you think your child or a young person you know might fit these age ranges and conditions, a doctor or the research team can provide more detailed information about who can and cannot take part. They will explain everything clearly.

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 the young person aged between 13 and 17 and has schizophrenia?
OR, is the young person aged between 5 and 17 and has autism with irritability?
Is the young person comfortable attending regular doctor and study visits?
Are you, as a parent/guardian, able to support their participation?

Answer every question to see your result.

What does participation involve?

If a young person takes part in this study, they will receive one of the study medicines (KarXT or KarX-EC). They will have regular visits with the study team, who will keep a close eye on their health and how they are feeling. These visits will involve various checks, like physical exams, talking about any side effects, and maybe some questionnaires to see how their symptoms are doing.

We will be looking very closely for any changes, especially any new symptoms or side effects that appear while on the medicine. This includes checking for things like changes in mood, thoughts of harming oneself, or any unusual movements. There will also be a follow-up period after the medicine stops to make sure everyone is still doing well.

The total length of time a person is in the study isn't stated here, but it would involve taking the medicine for a while and then having follow-up checks. All blood tests, doctor appointments, and assessments will be explained in detail before anyone agrees to join.

Potential risks and benefits

Taking part in a study like this might offer the chance to try a new medicine that isn't widely available yet, which could potentially help manage the young person's symptoms. However, like all medicines, KarXT and KarX-EC could have side effects, some of which might be unpleasant or, in rare cases, serious. The research team will explain all known risks and benefits clearly, and doctors will carefully monitor participants for any problems. It's very important to remember that joining is a personal choice, and participants are free to leave the study at any time, for any reason, without it affecting their regular medical care.

Locations (1)

Some site locations are approximate. We're improving this — please verify with the trial team before travelling.

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Unverified
Romania

Common questions

What are KarXT and KarX-EC?

They are new medicines being tested to see how safe and effective they are for certain conditions in young people.

What conditions are being studied?

The study is for teenagers with schizophrenia and children/teenagers with irritability linked to autism.

What does a 'safety study' mean?

It means the main focus is to carefully watch for and record any side effects or health problems that might happen while taking the medicine.

Will my child definitely get better?

Studies cannot promise that a medicine will work or that someone will get better. The goal is to gather information about the medicine's safety and effects.

Can we stop participating at any time?

Yes, taking part in a study is voluntary, and you can withdraw at any point without it affecting your child's medical care.