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ADZENYS XR-ODT™ in Children (4 to <6 Years) Diagnosed With Attention-deficit/Hyperactivity Disorder

NCT07169162 · Status: WITHDRAWN · Phase: PHASE4 · Type: INTERVENTIONAL

Last updated 2025-10-03

No results posted yet for this study

Summary

This is a randomized, double-blind, flexible dose-titration, placebo-controlled, parallel-group study designed to evaluate the efficacy, safety, and tolerability of ADZENYS XR-ODT compared to placebo in children with ADHD.

Conditions

  • Attention Deficit Hyperactivity Disorder

Interventions

DRUG

ADZENYS XR-ODT

ADZENYS XR-ODT™ (amphetamine) is an extended-release orally disintegrating tablet approved for once-daily oral administration for the treatment of ADHD in patients 6 years and older.

DRUG

Placebo Oral Tablet

Participants in this arm will be given placebo as matching ODT once daily during the double-blind treatment period.

Sponsors & Collaborators

  • Premier Research

    collaborator OTHER

  • Aytu BioPharma, Inc.

    lead INDUSTRY

Principal Investigators

  • Carolyn R Sikes, PhD · Neos Therapeutics, Inc

  • 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
5 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-05-31
Primary Completion
2025-09-05
Completion
2025-09-05
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 NCT07169162 on ClinicalTrials.gov