KarXT plus KarX-EC for irritability in children and teens with autism

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 3 interventional trial evaluating KarXT alone, KarX-EC alone, and the combination of KarXT with KarX-EC against a matching placebo for irritability associated with autism spectrum disorder in pediatric participants. Eligible participants are children and adolescents with ASD confirmed by DSM-5-TR criteria and K-SADS-PL, who exhibit irritability as measured by the ABC-I score and CGIS irritability at screening and baseline. Exclusion criteria omit certain primary psychiatric disorders, but allow ADHD as a comorbidity if stable and not primary. The study is conducted at multiple sites in the United States under Bristol-Myers Squibb as lead sponsor.

Why it matters

Who can join: the full rules

Inclusion Criteria

* Participants must have a confirmed diagnosis of ASD, as defined by the Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition, Text Revision (DSM-5-TR) criteria, confirmed by the K-SADS-PL and must be experiencing symptoms of irritability.
* Participants must have ABC-I ≥18 (Irritability subscale of the ABC) and CGIS specific to irritability ≥4, at screening and baseline (Day 1).

Exclusion Criteria

* Participants must not have a current primary DSM-5 diagnosis of bipolar disorder, including bipolar II disorder, schizophrenia, schizoaffective disorder, major depressive episode as determined by clinical instrument, or post-traumatic stress disorder (PTSD).
* Exception Include: Participants with comorbid ADHD, provided that attention deficit/hyperactivity disorder (ADHD) is not the primary disorder, the participant is adequately treated and based on the investigator judgment the disorder is clinically stable.
* Participants must not have history/presence of clinically significant disease or disorder that would jeopardize participant safety or validity of study results.
* Participants must not have a risk for suicidal behavior, and any clinically significant abnormal laboratory test.
* Other protocol-defined Inclusion/Exclusion criteria may apply.

Where it's running

• Cortica - Glendale
  Glendale, California, United States Recruiting
• Cortica - Marin
  San Rafael, California, United States Recruiting
• EmVenio Research - Chicago
  Chicago, Illinois, United States Recruiting
• CHU Sainte-Justine
  Montreal, Quebec, Canada Recruiting
• Local Institution - 0036
  Dothan, Alabama, United States Not yet recruiting
• Local Institution - 0236
  Phoenix, Arizona, United States Not yet recruiting

Study contacts

• Study coordinator: BMS Clinical Trials Contact Center www.BMSClinicalTrials.com
• Email: Clinical.Trials@bms.com
• Phone: 855-907-3286

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• KarXT + KarX-EC for irritability in kids and teens with autism

  This study tests whether KarXT plus KarX-EC can reduce irritability in children and adolescents with autism.

  Recruiting at 3 sites Phase 3 Bristol-Myers Squibb · Phoenix, Arizona and 66 other locations · NCT07285798

• Treatment of irritability in children with Autism Spectrum Disorder using Lumateperone

  This study is testing if a medication called Lumateperone can help reduce irritability in children with Autism Spectrum Disorder aged 5 to 17.

  Recruiting at 28 sites Phase 3 Intra-Cellular Therapies, Inc. · Little Rock, Arkansas and 40 other locations · NCT06706674

• Treatment of irritability in children with autism using lumateperone

  This study is testing if a medication called lumateperone can help reduce irritability in children with autism, ages 5 to 17.

  Recruiting at 32 sites Phase 3 Intra-Cellular Therapies, Inc. · Dothan, Alabama and 38 other locations · NCT06690398

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.