ADZENYS XR-ODT™ in Children (4 to <6 Years) Diagnosed With Attention-deficit/Hyperactivity Disorder
← catalyst calendarSponsored by Aytu BioPharma, Inc. (industry) · AYTU — their whole pipeline →. With Premier Research.
Phase
Phase 4
Status
Withdrawn
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
0actual
Sites
1
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
Enrollment never started
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | May 2019 | estimated | When the study began enrolling |
| Primary completion | 2025-09-05 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-09-05 | actual | The whole study's end, after follow-up |
| First posted | 2025-09-11 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-03 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Attention Deficit Hyperactivity Disorder
Interventions
- Drug: ADZENYS XR-ODT
- Drug: Placebo Oral Tablet
Primary outcome
what the primary-completion date above is the date OFAttention-deficit/hyperactivity disorder Rating Scale-IV Preschool Version Total Score
measured Visit 10/Day 56
Permalink · AYTU's whole pipeline · Catalyst calendar · Every registered study · What changed