An Efficacy and Safety Study w/ Azstarys® in Children 4-12 Years of Age With ADHD
Public ClinicalTrials.gov record NCT05685732. 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, Randomized, Double Blind, Efficacy and Safety Study With Azstarys® in Children 4 to 12 Years of Age With Attention Deficit/Hyperactivity Disorder
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
This is a multicenter, dose-optimized, randomized, double-blind, placebo controlled, efficacy and safety study with Azstarys® in children 4 to 12 years of age with attention-deficit/hyperactivity disorder (ADHD). Azstarys® contains dexmethylphenidate (d-MPH) and serdexmethylphenidate (SDX), a prodrug of d-MPH and is orally administered. The primary objective is to determine the efficacy of Azstarys® compared to placebo in treating children ages 4 to 12 years old with ADHD. The study will consist of two randomized and blinded treatment cohorts ages 4 to 5 years of age and 6 to 12 years of age. Randomization will be applied separately with a starting dose up-titration at different dose levels for each cohort. 130 and 100 subjects will be enrolled, respectively. Approximately 20 sites will participate.
Study identification
- NCT ID
- NCT05685732
- Recruitment status
- Completed
- Study type
- Interventional
- Phase
- Phase 4
- Enrollment
- 246 participants
Conditions and interventions
Conditions
Interventions
Drug · Other
Eligibility (public fields only)
- Age range
- 4 Years to 12 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
- Mar 21, 2023
- Primary completion
- May 1, 2024
- Completion
- May 1, 2024
- Last update posted
- May 12, 2025
2023 – 2024
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 - Jacksonville | 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 | — |
| Sky Clinical Research Network Group P.C. | Atlanta | Georgia | 30339 | — |
| CenExel IResearch, LLC - Decatur | Decatur | Georgia | 30030 | — |
| CenExel iResearch, LLC | Savannah | Georgia | 31405 | — |
| DelRicht Research - Touro Medical Center | New Orleans | Louisiana | 70115 | — |
| St Charles Psychiatric Associates & Midwest Research Group | Saint Charles | Missouri | 80112 | — |
| Boeson Research | Missoula | Montana | 75093 | — |
| Alivation Research, LLC | Lincoln | Nebraska | 68526 | — |
| Center for Psychiatry and Behavioral Medicine Inc | Las Vegas | Nevada | 89128 | — |
| Clinical Neuroscience Solutions--Memphis | 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 NCT05685732, 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 12, 2025 · Synced Sep 4, 2026
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Open the official record
The complete protocol, eligibility criteria, and contact information for NCT05685732 live on ClinicalTrials.gov.