New ADHD drug studied in preschoolers: hope or hype?

NCT ID NCT05721235

Completed Symptom relief Sponsor: Corium, Inc. Source: ClinicalTrials.gov ↗

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study looked at the safety and tolerability of the drug Azstarys in 123 children aged 4 to 5 with ADHD over 12 months. Researchers monitored sleep, weight, and height changes, as well as how well the drug controlled ADHD symptoms. The goal was to see if this medication could be a safe option for managing ADHD in this young age group.

What this could mean

Our plain-language read of the trial. This is informational only — not medical advice or a prediction.

Active substance: Azstarys (serdexmethylphenidate and dexmethylphenidate)
What this could lead to: If successful, this could provide a treatment option for managing ADHD symptoms in younger children, potentially improving focus and behavior.
What could go wrong: This is a small, early-phase study without a placebo group, so results may not confirm effectiveness. Side effects like sleep problems or changes in weight and height are possible.

This is an AI summary of the original study and may miss details. Read our disclaimer.

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

ATTENTION DEFICIT HYPERACTIVITY DISORDER

Contacts and locations

Locations

AIM Trials

Plano, Texas, 75093, United States
Accel Research Sites - Lakeland

Lakeland, Florida, 33803, United States
Accel Research Sites - Maitland

Maitland, Florida, 32751, United States
Advanced Research Center (ARC)

Anaheim, California, 92805, United States
Alivation Research, LLC

Lincoln, Nebraska, 68526, United States
Boeson Research

Missoula, Montana, 59804, United States
CNS Healthcare - Orlando

Orlando, Florida, 32801, United States
CenExel iResearch, LLC

Savannah, Georgia, 31405, United States
Center For Psychiatry and Behavioral Medicine Inc

Las Vegas, Nevada, 89128, United States
Clinical Neuroscience Solution, Inc

Memphis, Tennessee, 38119, United States
Clinical Neuroscience Solutions - Orlando

Jacksonville, Florida, 32256, United States
DelRicht Research - Touro Medical Center

New Orleans, Louisiana, 70115, United States
Flourish Research

San Antonio, Texas, 78229, United States
Houston Clinical Trials

Bellaire, Texas, 77401, United States
IMMUNOe International Research Center

Centennial, Colorado, 80112, United States
Preferred Research Partners (PRP)

Little Rock, Arkansas, 72211, United States
Sky Clinical Research Network Group P.C.

Union City, Georgia, 30291, United States
South Florida Research Phase I-IV INC

Miami Springs, Florida, 33166, United States
St Charles Psychiatric Associates & Midwest Research Group

Saint Charles, Missouri, 63304, United States
iResearch Atlanta

Decatur, Georgia, 30030, United States

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