KarXT + KarX-EC for Irritability in Autism

Not yet recruiting at 43 trial locations

Overseen By BMS Study Connect www.BMSStudyConnect.com

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Bristol-Myers Squibb

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

Bristol-Myers Squibb

Principal Investigator

Bristol-Myers Squibb

Are You a Good Fit for This Trial?

This trial is for children and adolescents with Autism Spectrum Disorder who experience irritability. Specific eligibility details are not provided, but typically participants must meet diagnostic criteria for autism and have a certain level of irritability.

Inclusion Criteria

Participants must have ABC-I ≥18 (C18 on the Irritability subscale of the ABC-I) and CGIS specific to irritability ≥4, at screening and baseline (Day 1)

I have been diagnosed with ASD and often feel irritable.

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

I don't have any serious health issues that could risk my safety or affect the study's results.

What Are the Treatments Tested in This Trial?

Interventions

• KarXT + KarX-EC

Trial Overview

The study is testing the effectiveness of KarXT combined with KarX-EC in reducing irritability in young individuals with autism. It's likely that some participants will receive the actual medications while others may receive a placebo for comparison.

How Is the Trial Designed?

Group I: KarXT + KarX-EC Arm Experimental Treatment 2 Interventions

Group II: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

Bristol-Myers Squibb

Lead Sponsor

Trials

2,731

Recruited

4,127,000+

Headquarters

New York City, USA

Known For

Oncology & Cardiovascular

Top Products

Eliquis, Opdivo, Revlimid, Orencia

Christopher Boerner

Bristol-Myers Squibb

Chief Executive Officer since 2023

PhD in Business Administration from the Haas School of Business, University of California, Berkeley; BA in Economics and History from Washington University in St. Louis

Deepak L. Bhatt

Bristol-Myers Squibb

Chief Medical Officer since 2024

MD from Yale University; MSc in Clinical Epidemiology from the University of Pennsylvania