Completed PHASE4 INTERVENTIONAL 4-arm NCT05685732

An Efficacy and Safety Study w/ Azstarys® in Children 4-12 Years of Age With ADHD (KP415P01)

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

Sponsor: Almac

Conditions Attention Deficit/Hyperactivity Disorder

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

Updated 10 times since 2023 Last updated: May 12, 2025 Started: Mar 22, 2023 Primary completion: May 2, 2024 Completion: May 2, 2024

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

This PHASE4 trial investigates Attention Deficit/Hyperactivity Disorder and is currently completed. Almac leads this study, which shows 10 recorded versions since 2023 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

Change History

10 versions recorded

Dec 2025 — Present [monthly]

Completed PHASE4
Jun 2025 — Dec 2025 [monthly]

Completed PHASE4
Sep 2024 — Jun 2025 [monthly]

Completed PHASE4
Aug 2024 — Sep 2024 [monthly]

Completed PHASE4

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

Active Not Recruiting PHASE4

▶ Show 5 earlier versions

May 2024 — Jul 2024 [monthly]

Active Not Recruiting PHASE4

Status: Recruiting → Active Not Recruiting
Feb 2024 — May 2024 [monthly]

Recruiting PHASE4
Jun 2023 — Feb 2024 [monthly]

Recruiting PHASE4
Mar 2023 — Jun 2023 [monthly]

Recruiting PHASE4

Status: Not Yet Recruiting → Recruiting
Feb 2023 — Mar 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

Data source: Corium, Inc.

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

Study Locations

Anaheim, United States , Atlanta, 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 and 10 more locations