Can a new drug calm irritability in kids with autism?
NCT ID NCT06557902
First seen Jul 24, 2026 · Last updated Jul 24, 2026
Summary
This early-stage trial is testing an experimental drug called lumateperone in children aged 5 to 12 who have autism spectrum disorder and symptoms of irritability. The study aims to see how the body processes the drug and whether it is safe and tolerable at different doses. It is a first step toward possibly finding a new treatment option for irritability in this population.
What this could mean
Our plain-language read of the trial. This is informational only — not medical advice or a prediction.
- Active substance
- an experimental drug called lumateperone, given as capsules or orally disintegrating tablets
- What this could lead to
- If safe and well-tolerated, this could pave the way for larger studies testing whether lumateperone helps ease irritability in children with autism.
- What could go wrong
- This is a very early, small phase 1 trial focused on safety and drug levels, not on whether the drug works. Side effects are possible, and the drug may not prove effective in later studies.
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.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
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Locations
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APG Research LLC
Orlando, Florida, 32803, United States
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Alivation Research LLC
Lincoln, Nebraska, 68526, United States
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Atlanta Center for Medical Research
Atlanta, Georgia, 30331, United States
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CenExeli Research LLC
Atlanta, Georgia, 30030, United States
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CenExeli Research LLC 1
Savannah, Georgia, 31405, United States
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Core Clinical Research
Everett, Washington, 98201, United States
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Midwest Research Group
Saint Charles, Missouri, 63304, United States
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