Does Your Child Have Autism and Experience Irritability?
Denali Health is enrolling children and teens in a clinical research study evaluating an investigational medication for irritability associated with autism, including frequent severe tantrums, aggression, or self-injurious behavior.
Led by Dr. Maria E. Johnson, MD · Board-Certified Physician & Principal Investigator
See If Your Child May Qualify
Complete this form, and our study team will contact you to explain the autism research study and discuss potential eligibility.
Supporting Kids With Autism & Their Families
Every child experiences autism differently. Our pediatric team provides a calm, understanding environment for children experiencing sensory overload and irritability.
When Irritability Affects Everyday Life
Some children and teens with autism experience irritability that can make daily routines challenging for them and their families. Symptoms may include:
Frequent Severe Tantrums
Intense outbursts that may be difficult to manage.
Aggression
Physical aggression toward others or objects.
Self-Injurious Behavior
Behaviors such as hitting or biting oneself.
This study focuses on irritability associated with autism.
Who May Qualify for This Study?
Your child may be eligible for this study if they:
Confirmed Autism Diagnosis
Have a confirmed diagnosis of autism spectrum disorder.
Symptoms of Irritability
Experience symptoms of irritability.
Meet the Age Requirements
Meet the age requirements for the study’s open enrollment group.
Parent or Guardian Support
Have a parent or guardian who can support participation and attend required visits.
What Is This Study Evaluating?
This clinical research study will evaluate the effectiveness, safety, and tolerability of an investigational medication for irritability associated with autism in children and teens.
Participants will be randomly assigned to receive either the investigational medication or a placebo. A placebo looks like the study medication but contains no active study drug. Neither families nor the study team will know which treatment a participant receives during the blinded treatment period.
These details are based on the study design concept and remain subject to the final approved protocol.
Guided by Pediatric Specialists Every Step of the Way
From initial screening to the 8-week study treatment period and follow-up, every visit is paced for your child's comfort.
Study at a Glance
Planned participation
| Detail | Planned participation |
|---|---|
| Overall duration | Approximately 12 weeks |
| Treatment period | 8 weeks |
| Study medication or placebo | Taken by mouth twice daily |
| Assessments | Scheduled study visits and safety monitoring |
What Can Families Expect?
Screening
The study team will review your child’s medical history, symptoms, medications, and other requirements to determine eligibility. Screening may take up to two weeks.
Study Treatment Period
Eligible participants will receive the investigational medication or placebo for eight weeks and attend scheduled study assessments.
Safety Follow-Up
A safety follow-up is planned approximately two weeks after the last dose for participants who do not enter the separate extension study.
Study assessments may include questionnaires, physical examinations, blood tests, vital signs, and heart monitoring with an ECG. The team will explain all procedures before you decide whether your child will participate.
A Study Team to Guide You Through the Process
Our team can explain the study, answer your questions, and help you understand what participation may involve.
Before you make a decision, we will discuss:
Compensation and travel support details have not yet been confirmed.
Dr. Maria E. Johnson, MD
Board-Certified Physician & Principal Investigator
Denali Health Atlanta
Dr. Maria E. Johnson leads pediatric research initiatives at Denali Health Atlanta, dedicated to providing compassionate, thorough, and scientifically rigorous clinical care for children, teens, and their families.
Learn More in Three Simple Steps
1. Request Information
Complete the inquiry form with your contact information.
2. Speak With the Study Team
Our team will explain the study and discuss potential eligibility and enrollment availability.
3. Attend Screening When Enrollment Opens
If your child may qualify, the team will explain the consent process and arrange screening when available.
Requesting information does not obligate your family to participate.
Questions Parents Often Ask
Have another question not answered here? Call our study team at (404) 999-2734
Have Questions About Our Autism Study?
We’re here to help you understand the study and what participation could involve for your family. Complete the form to request information and receive updates about enrollment.
Contact the study team
Clinic Location
5329 Memorial Drive, Suite A, Stone Mountain, GA 30083
Direct Phone
(404) 999-2734
info@denali-health.com