A Randomized, Double-blind, Parallel, Placebo-controlled, Flexible-dose Study of ADZENYS XR-ODT™ in Children Aged 4 to Less Than 6 Years Diagnosed With Attention-deficit/Hyperactivity Disorder (ADHD)

NCT07169162 Phase 4 WITHDRAWN

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.

Details

Lead sponsor	Aytu BioPharma, Inc.
Phase	Phase 4
Status	WITHDRAWN
Start date	2019-05
Completion	2025-09-05

Conditions

• Attention Deficit Hyperactivity Disorder

Interventions

• ADZENYS XR-ODT
• Placebo Oral Tablet

Primary outcomes

• Attention-deficit/hyperactivity disorder Rating Scale-IV Preschool Version Total Score — Visit 10/Day 56
  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

Countries

United States