๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-08-27

A Study to Evaluate the Long-term Safety and Tolerability of KarXT and KarX-EC for the Treatment of Schizophrenia and Autism-Related Irritability in Adolescents, Respectively (NCT07424404)

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

๐ŸŸข Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Karuna Therapeutics, Inc., a Bristol Myers Squibb company

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

The purpose of this study is to evaluate the long-term safety and tolerability of KarXT and KarX-EC for the treatment of Schizophrenia and autism-related irritability in adolescents, respectively

Who can join: Review the eligibility criteria below.

Location: Local Institution - 0054 โ€” Dothan, Alabama

Age range: 5 Years to 17 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (91 Sites)

Showing the first 25 of 91 sites.

  • Local Institution - 0054 โ€” Dothan, Alabama
  • Local Institution - 0163 โ€” Phoenix, Arizona
  • Advanced Research Center Inc. โ€” Anaheim, California
  • Local Institution - 0159 โ€” Anaheim, California
  • Inland Psychiatric Medical Group. โ€” Chino, California
  • Proscience Research Group โ€” Culver City, California
  • Local Institution - 0162 โ€” Glendale, California
  • Local Institution - 0153 โ€” Los Angeles, California
  • Local Institution - 0158 โ€” Orange, California
  • Local Institution - 0174 โ€” San Diego, California
  • Local Institution - 0089 โ€” San Francisco, California
  • Local Institution - 0157 โ€” San Rafael, California
  • Local Institution - 0161 โ€” Colorado Springs, Colorado
  • Local Institution - 0154 โ€” New Haven, Connecticut
  • Local Institution - 0145 โ€” Boca Raton, Florida
  • Local Institution - 0160 โ€” Gainesville, Florida
  • Local Institution - 0164 โ€” Gainesville, Florida
  • Local Institution - 0168 โ€” Hollywood, Florida
  • Apg Research, Llc โ€” Orlando, Florida
  • Atlanta Center for Medical Research โ€” Atlanta, Georgia
  • Salveo Integrative Health - Lawrenceville โ€” Lawrenceville, Georgia
  • Denali Health Atlanta, LLC โ€” Stone Mountain, Georgia
  • Local Institution - 0175 โ€” Chicago, Illinois
  • EmVenio Research Center - Prime Healthcare โ€” Chicago, Illinois
  • Boston Children's Hospital โ€” Boston, Massachusetts

๐Ÿ“ž Contact the Study Coordinator

Phone: (855) 907-3286

Email: Clinical.Trials@bms.com

Coordinator details come directly from the registered NIH protocol. Confirm the study is still recruiting before traveling.

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Schizophrenia clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Contact the study coordinator using the phone/email above.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—