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

NCT07169162 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: NT0202.1009
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (1)

• Attention-deficit/hyperactivity disorder Rating Scale-IV Preschool Version Total Score

  Attention-Deficit/Hyperactivity Disorder Rating Scale-IV: Preschool Version (ADHD-RS-IV: Preschool Version) The ADHD-RS-IV Home and School checklists consist of the nine inattention and nine hyperactive/impulsive items that comprise the ADHD symptom criteria in the DSM-IV. Each item is rated on a four-point scale (0=never or rarely to 3=very often). Scores above the 93%ile are suspicious for but not diagnostic of preschool ADHD. Boys - Parent Inattention: 14 Hyperactivity/Impulsivity: 17 Total Score: 32/Teacher Inattention: 18 Hyperactivity/Impulsivity: 22 Total Score: 38 Girls - Parent Inattention: 12 Hyperactivity/Impulsivity: 14 Total Score: 24/Teacher Inattention: 11 Hyperactivity/Impulsivity: 13 Total Score: 24

  Visit 10/Day 56

Secondary Outcomes (3)

• Clinical Global Impression - Severity

  Visit 10/Day 56

• Attention-deficit/hyperactivity disorder Rating Scale-IV Preschool Version Total Score

  Visits 3-9 (Days 7, 14, 21, 28, 35, 42, 49)

• Clinical Global Impression - Severity

  Visits 3-9 (Days 7, 14, 21, 28, 35, 42, 49)

Other Outcomes (2)

• Treatment-emergent adverse events, vital signs, clinical laboratory evaluations, and ECG results

  Visits 3-9 (Days 7, 14, 21, 28, 35, 42, 49)

• Children's Sleep Habits Questionnaire (CSHQ) Subscale and Total Sleep Disturbance Scores

  Visits 3-9 (Days 7, 14, 21, 28, 35, 42, 49)

Study Arms (2)

ADZENYS XR-ODT

EXPERIMENTAL

Subjects will be assigned to receive ADZENYS XR-ODT orally disintegrating tablets in a randomized manner. Subjects will receive their dose once daily in the morning. All subjects will begin taking ADZENYS XR ODT 3.1 mg per day the morning after qualifying at Visit 2. The dose for each subject will be titrated in a stepwise fashion each week through Week 6 (Visit 8) based on the investigator's judgment of subject's clinical response (i.e., efficacy and tolerability) to 6.3 mg, 9.4 mg, 12.5 mg, 15.7 mg, up to 18.8 mg once daily, until an optimal dose or the highest dose is reached. No subject will receive a dose higher than 18.8 mg/day. Doses will comprise 1 or 2 tablets to achieve the (rounded) assigned dose. Once subjects reach an optimal dose of study drug, they will continue that dose for the remainder of the study.

Drug: ADZENYS XR-ODT

Placebo

PLACEBO COMPARATOR

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

Drug: Placebo Oral Tablet

Interventions

ADZENYS XR-ODT DRUG

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.

ADZENYS XR-ODT

Placebo Oral Tablet DRUG

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

Placebo

Eligibility Criteria

• Age: 4 Years - 5 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Subject meets DSM-5 criteria for ADHD, combined, hyperactive/impulsive, or inattentive presentation made during a clinical interview by an experienced clinician and confirmed with the K-SADS-PL.
• Subject has an age- and sex-adjusted rating of ≥90th percentile Total Score on the ADHD RS-IV Preschool Version (rated over past 6 months).
• Subject has a score of ≥4 on the CGI-S at Visit 2 (Baseline).
• Subject has had symptoms consistent with ADHD for at least 6 months.
• Subject has a Peabody Picture Vocabulary Test, 4th edition Standard Score of ≥70 at Visit 1 (Screening Visit).
• Subject has undergone an adequate course of nonpharmacological treatment for ADHD based on investigator judgment or the investigator considers the subject's condition severe enough to enroll without undergoing prior nonpharmacological treatment. Subjects who have been on a previous pharmacological treatment for ADHD may be enrolled provided they meet other entrance criteria.
• Subject has participated in structured group activity (e.g., preschool, daycare, camp) for at least 1 month that in the investigator's opinion allows assessment of symptoms and impairment in a setting outside of the home.

You may not qualify if:

• Other psychiatric diagnoses
• Significant cognitive impairment
• Chronic medical illnesses
• Structural cardiac defects
• Significant abnormal lab tests
• Taking disallowed medications
• Subject has history of or presence at Screening of long QT syndrome or QTc greater than 450 msec at Screening (using Fridericia's formula: QTcF) or any other clinically significant 12-lead ECG abnormality.
• Subject has a history of chronic vocal or motor tics or Tourette's syndrome or a family history of Tourette's syndrome.
• Subject has history or presence of suicidal ideation, significant self-injurious behavior, or violent behavior.
• Subject shows evidence of current physical, sexual, or emotional abuse.
• Subject has a height or a weight less than or equal to the 5th percentile for age and sex at the Screening Visit.
• Subject's blood pressure measurements exceed the 95th percentile for age, sex, and height at the Screening Visits (Visit 1) and/or Baseline Visit (Visit 2) per the American Academy of Pediatrics 2017 updated guidance.
• Subject's biological parent has a history of bipolar disorder.
• A parent/caregiver or someone living in the subject's home has a current or recent (past 12 months) history of substance abuse.

Sponsors & Collaborators

• Aytu BioPharma, Inc.: lead
• Premier Research: collaborator

Study Sites (1)

Center for Psychiatry and Behavioral Medicine, Inc.

Las Vegas, Nevada, 89128, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

Amphetamine

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Intervention Hierarchy (Ancestors)

Amphetamines; Phenethylamines; Ethylamines; Amines; Organic Chemicals

Study Officials

• Carolyn R Sikes, PhD

  Neos Therapeutics, Inc

  STUDY DIRECTOR

• Ann Childress, MD

  Center for Psychiatry And Behavioral Medicine Inc.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: Placebo-controlled

Study Record Dates

• First Submitted: September 5, 2025
• First Posted: September 11, 2025
• Study Start: May 1, 2019
• Primary Completion: September 5, 2025
• Study Completion: September 5, 2025
• Last Updated: October 3, 2025

Record last verified: 2025-09

Locations

US (1)