Autism and Irritability Study

Now enrolling teens ages 13 to 17

This Phase 3 study, called the Starfish study, examines whether KarXT + KarX-EC, an investigational medication, can reduce irritability, such as aggression, meltdowns and self-injury, in children and teens with autism.

Study directors: Elysa Marco, MD, and Kevin Shapiro, MD, PhD

Fill Out Interest Form Email the Study Team

A teenager sitting on a couch holding a game controller

AgesCurrently enrolling 13 to 17 years
Visits14 over up to 15 weeks
LocationsCortica Marin and Glendale
CostNo cost to participate, plus up to $300 per visit

Who can join

Ages 5 to 17 years (currently enrolling ages 13 to 17 years)
A diagnosis of autism with symptoms of irritability, such as aggression, meltdowns, tantrums or self-injury

Your child may not be able to join if they have

A primary diagnosis of bipolar disorder, schizophrenia, major depression or PTSD
Current use of certain medications (our study team can talk this through with you)

What to expect

Testing: Behavior assessments, caregiver questionnaires and medical evaluations, including vital signs, an ECG, bloodwork and a urine test.
Visits: 14 visits over up to 15 weeks: 9 in clinic and 5 by phone.
Study medication: Participants are randomly assigned to the study medication or a placebo, taken by mouth twice a day for 8 weeks. Eligible participants may then join a 52-week extension study where everyone receives the study medication.
Cost: Medical visits and medications in the context of research are provided to families at no cost. We offer full travel support for families from outside the area.
Payment: Families receive $300 for each on-site visit ($150 for the participant and $150 for the caregiver) and $50 for each phone visit.

Official study title: A Phase 3 Study to Assess KarXT + KarX-EC for the Treatment of Irritability Associated with Autism Spectrum Disorder in Children and Adolescents (5 to 17 years of age)