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Safety, Tolerability and Pharmacokinetics of Lumateperone in Pediatric Patients With Autism Spectrum Disorder

Studying Lumateperone's effects in children with autism.

Recruiting
5-12 years
All
Phase 1

This study looks at how safe and easy it is for kids with Autism Spectrum Disorder (ASD) to take a medicine called lumateperone. Kids in the study will be aged between 5 and 12 and a half. They should have some symptoms of irritability and be able to swallow capsules. The study will not include kids with other main mental health problems or those with a history of certain health issues. The goal is to check how the medicine behaves in the body (this is called pharmacokinetics, or PK).

  • The study is open-label, meaning everyone knows what medicine is being taken.
  • It's a Phase 1b study, which is an early step in testing a new treatment.
  • Many centers will help conduct this study, making it a multicenter study.

The doctors will watch for any side effects (safety and tolerability) and see how the medicine moves and changes in the body (PK). The study won't include kids with a history of certain heart issues, suicidal thoughts, and behaviors, or those with uncontrollable behaviors. If you are thinking about joining, it is important to talk to your doctor about it first.

Study details
    Autism Spectrum Disorder

NCT06557902

Intra-Cellular Therapies, Inc.

10 October 2024

Step 1 Get in touch with the nearest study center
What happens next?
  • You can expect the study team to contact you via email or phone in the next few days.
  • Sign up as volunteer  to help accelerate the development of new treatments and to get notified about similar trials.

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Learn more about clinical trials

What is a clinical trial?

A clinical trial is a study designed to test specific interventions or treatments' effectiveness and safety, paving the way for new, innovative healthcare solutions.

Why should I take part in a clinical trial?

Participating in a clinical trial provides early access to potentially effective treatments and directly contributes to the healthcare advancements that benefit us all.

How long does a clinical trial take place?

The duration of clinical trials varies. Some trials last weeks, some years, depending on the phase and intention of the trial.

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Compensation varies per trial. Some offer payment or reimbursement for time and travel, while others may not.

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Clinical trials follow strict ethical guidelines and protocols to safeguard participants' health. They are closely monitored and safety reviewed regularly.
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