Completed PHASE4 INTERVENTIONAL 1-arm NCT05721235

A Safety/Tolerability and PK Study With Azstarys® in Children With ADHD (KP415P02)

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

Sponsor: Almac

Conditions Attention Deficit/Hyperactivity Disorder

Interventions Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)

Updated 8 times since 2023 Last updated: Sep 9, 2025 Started: Jun 2, 2023 Primary completion: Aug 29, 2025 Completion: Aug 29, 2025

This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

A PHASE4 clinical study on Attention Deficit/Hyperactivity Disorder, this trial is completed. The trial is conducted by Almac and has accumulated 8 data snapshots since 2023. Longitudinal tracking of this trial contributes to a broader understanding of treatment development timelines.

Status Flow

Change History

8 versions recorded

Dec 2025 — Present [monthly]

Completed PHASE4
Oct 2025 — Dec 2025 [monthly]

Completed PHASE4

Status: Active Not Recruiting → Completed
Jul 2025 — Oct 2025 [monthly]

Active Not Recruiting PHASE4
Sep 2024 — Jul 2025 [monthly]

Active Not Recruiting PHASE4

Status: Recruiting → Active Not Recruiting
Jul 2024 — Sep 2024 [monthly]

Recruiting PHASE4

▶ Show 3 earlier versions

Feb 2024 — Jul 2024 [monthly]

Recruiting PHASE4
Jun 2023 — Feb 2024 [monthly]

Recruiting PHASE4

Status: Not Yet Recruiting → Recruiting
Mar 2023 — Jun 2023 [monthly]

Not Yet Recruiting PHASE4

First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:

Almac
Corium, Inc.
Premier Research
Prometrika, LLC
Worldwide Clinical Trials

Data source: Corium, Inc.

For direct contact, visit the study record on ClinicalTrials.gov .

Study Locations

Anaheim, United States , Bellaire, United States , Centennial, United States , Decatur, United States , Jacksonville, United States , Lakeland, United States , Las Vegas, United States , Lincoln, United States , Little Rock, United States , Maitland, United States and 10 more locations