A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD
Public ClinicalTrials.gov record NCT05721235. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Multicenter, Dose-Optimized, Open-Label, Safety/Tolerability and Pharmacokinetic Study With Azstarys® in Children 4 and 5 Years of Age With Attention-Deficit/Hyperactivity Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
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.
Study identification
- NCT ID
- NCT05721235
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 123 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 4 Years to 5 Years
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jun 2, 2023 (Actual)
- Primary completion
- Jul 31, 2025 (Actual)
- Completion
- Jul 31, 2025 (Actual)
- Last update posted
- May 8, 2026
2023 – 2025
United States locations
- U.S. sites
- 20
- U.S. states
- 12
- U.S. cities
- 20
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| Preferred Research Partners (PRP) | Little Rock | Arkansas | 72211 | — |
| Advanced Research Center (ARC) | Anaheim | California | 92805 | — |
| IMMUNOe International Research Center | Centennial | Colorado | 80112 | — |
| Clinical Neuroscience Solutions - Orlando | Jacksonville | Florida | 32256 | — |
| Accel Research Sites - Lakeland | Lakeland | Florida | 33803 | — |
| Accel Research Sites - Maitland | Maitland | Florida | 32751 | — |
| South Florida Research Phase I-IV INC | Miami Springs | Florida | 33166 | — |
| CNS Healthcare - Orlando | Orlando | Florida | 32801 | — |
| iResearch Atlanta | Decatur | Georgia | 30030 | — |
| CenExel iResearch, LLC | Savannah | Georgia | 31405 | — |
| Sky Clinical Research Network Group P.C. | Union City | Georgia | 30291 | — |
| DelRicht Research - Touro Medical Center | New Orleans | Louisiana | 70115 | — |
| St Charles Psychiatric Associates & Midwest Research Group | Saint Charles | Missouri | 63304 | — |
| Boeson Research | Missoula | Montana | 59804 | — |
| Alivation Research, LLC | Lincoln | Nebraska | 68526 | — |
| Center For Psychiatry and Behavioral Medicine Inc | Las Vegas | Nevada | 89128 | — |
| Clinical Neuroscience Solution, Inc | Memphis | Tennessee | 38119 | — |
| Houston Clinical Trials | Bellaire | Texas | 77401 | — |
| AIM Trials | Plano | Texas | 75093 | — |
| Flourish Research | San Antonio | Texas | 78229 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05721235, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted May 8, 2026 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05721235 live on ClinicalTrials.gov.