Trial Radar
Sign in

NCT lookup

Pull any trial record directly from ClinicalTrials.gov.

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

NCT07285798

Not Yet RecruitingPhase 3

Sponsor: Bristol-Myers Squibb

Conditions: Irritability Associated With Autism Spectrum Disorder

Interventions: KarXT, KarX-EC, KarXT + KarX-EC Matching Placebo

Countries: United States, France, Germany, Hungary, India, Japan, Poland, Romania

The purpose of this study is to assess KarXT + KarX-EC for the treatment of irritability associated with autism in children and adolescents.

Eligibility overview

Sex: ALL

Age: 5 Years to 17 Years

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria
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 an 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.
Locations (54)
  • Phoenix, Arizona, United States
  • Glendale, California, United States
  • Los Angeles, California, United States
  • Orange, California, United States
  • San Juan Capistrano, California, United States
  • San Rafael, California, United States
  • New Haven, Connecticut, United States
  • Orlando, Florida, United States
  • Chicago, Illinois, United States
  • Lexington, Massachusetts, United States
  • Columbia, Missouri, United States
  • Lincoln, Nebraska, United States
  • Neptune City, New Jersey, United States
  • Staten Island, New York, United States
  • Cincinnati, Ohio, United States
  • Pittsburgh, Pennsylvania, United States
  • Spring, Texas, United States
  • Orem, Utah, United States
  • Everett, Washington, United States
  • Bron, France
  • Eysines, France
  • Paris, France
  • Gdansk, Germany
  • Budapest, Hungary
  • Budapest, Hungary
  • Siófok, Hungary
  • Szeged, Hungary
  • Kozhikode, Kerala, India
  • Sakri, Maharashtra, India
  • Kolkata, West Bengal, India
  • + 24 more on CT.gov