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

NCT05685732 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 246

Last updated 2025-05-13

Study results available
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Summary

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.

Conditions

  • Attention Deficit/Hyperactivity Disorder

Interventions

DRUG

Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)

Serdexmethylphenidate (SDX) and dexmethylphenidate (d-MPH)

OTHER

placebo

matching placebo

Sponsors & Collaborators

  • Premier Research Group plc

    collaborator UNKNOWN

  • Prometrika, LLC

    collaborator INDUSTRY

  • Almac

    collaborator INDUSTRY

  • Corium, Inc.

    lead INDUSTRY

Principal Investigators

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

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2023-03-22
Primary Completion
2024-05-02
Completion
2024-05-02
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 NCT05685732 on ClinicalTrials.gov