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

NCT05721235 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 123

Last updated 2026-05-08

Study results available
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Summary

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.

Conditions

  • Attention Deficit/Hyperactivity Disorder

Interventions

DRUG

Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)

Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)

Sponsors & Collaborators

  • Premier Research

    collaborator OTHER

  • Prometrika, LLC

    collaborator INDUSTRY

  • Almac

    collaborator INDUSTRY

  • Worldwide Clinical Trials

    collaborator OTHER

  • Corium, Inc.

    lead INDUSTRY

Principal Investigators

  • Ann Childress, MD · Center for Psychiatry And Behavioral Medicine Inc.

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
4 Years
Max Age
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2023-06-02
Primary Completion
2025-07-31
Completion
2025-07-31
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05721235 on ClinicalTrials.gov