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Study identifier: NCT05721235 Synced from ClinicalTrials.gov · August 06, 2026
● Study status: Completed

A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD

Condition: Attention Deficit/Hyperactivity Disorder  ·  Sponsor: Corium, Inc.

PhasePhase 4
Planned participants123
Who can joinAll sexes, 4 Years to 5 Years
Healthy volunteersNo

About this study

The is a multicenter, dose-optimized, open-label, safety/ tolerability and pharmacokinetic (PK) study with Azstarys® in children 4 and 5 years of age with attention-deficit/hyperactivity disorder (ADHD). The primary objective is to determine the safety and tolerability of treating children 4 and 5 years-of-age with ADHD with Azstarys® for up 12 months. Approximately 100 subjects will be enrolled. Approximately 20 sites will participate.

This description comes directly from the study's public registry record.

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No contact information is available for this study as per the public registry record.

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Locations (20)

Preferred Research Partners (PRP)Little Rock, Arkansas, United States
Advanced Research Center (ARC)Anaheim, California, United States
IMMUNOe International Research CenterCentennial, Colorado, United States
Clinical Neuroscience Solutions - OrlandoJacksonville, Florida, United States
Accel Research Sites - LakelandLakeland, Florida, United States
Accel Research Sites - MaitlandMaitland, Florida, United States
South Florida Research Phase I-IV INCMiami Springs, Florida, United States
CNS Healthcare - OrlandoOrlando, Florida, United States
iResearch AtlantaDecatur, Georgia, United States
CenExel iResearch, LLCSavannah, Georgia, United States
Sky Clinical Research Network Group P.C.Union City, Georgia, United States
DelRicht Research - Touro Medical CenterNew Orleans, Louisiana, United States

+ 8 more locations — full list on the registry record.

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