New ADHD drug studied in preschoolers: hope or hype?

NCT ID NCT05721235

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.

Disclaimer Read more

This is a summary of the original study . Summaries may miss details or leave out important information. Before applying or accepting participation, make sure you have read and understood the full study. Curemydisease.com takes no responsibility whatsoever for anything missed, misunderstood, or acted upon as a result of our summary — we know it does not capture everything.

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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.

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