Attention Deficit Hyperactivity DisorderPhase 4NCT07169162
ADZENYS XR-ODT™ in Children (4 to <6 Years) Diagnosed With Attention-deficit/Hyperactivity Disorder
A Phase 4 study testing ADZENYS XR-ODT in people with Attention Deficit Hyperactivity Disorder, run by Aytu BioPharma, Inc. at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 4 to 5 years
- Conditions the study is for
- Attention Deficit Hyperactivity Disorder
- What is being tested?
- ADZENYS XR-ODT
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- 1 siteUnited States
- Study dates
- May 2019to 5 Sep 2025
- Phase
- Phase 4
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 4 to 5 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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.
Who cannot join
- Other psychiatric diagnoses
- Significant cognitive impairment
- Chronic medical illnesses
- Structural cardiac defects
- Significant abnormal lab tests
- Taking disallowed medications
Show all 14Show fewer
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Center for Psychiatry and Behavioral Medicine, Inc.
Las Vegas, Nevada, 89128
About this study
Official title: 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)
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.
Read the detailed description
This randomized, double-blind, flexible-dose, placebo-controlled, parallel group study is designed to evaluate the efficacy, safety, and tolerability of ADZENYS XR-ODT compared to placebo in children with ADHD. Male and female children ages 4 to less than 6 years with a diagnosis of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (combined, inattentive, or hyperactive/impulsive) will be enrolled.
A Screening/Washout Period of up to 4 weeks (Days -28 to -1), which will include washout of any current ADHD medications (if applicable), will be followed by an 8-week, Randomized, Double-blind, Flexible-dose Period during which subjects will be randomly assigned to placebo or to ADZENYS XR-ODT once daily. All subjects will start on 3.1 mg of ADZENYS XR-ODT or matching placebo. The dose for each subject will be titrated in a stepwise fashion each week from Visit 3 to Visit 8 (Weeks 1 to 6) based on efficacy and tolerability to 6.3 mg; 9.4 mg; 12.5 mg; 15.7 mg; and 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. Subjects must remain on a stable dose for at least 2 weeks.
An optimal dose is one that produces a reduction from Baseline of ADHD symptoms (ADHD Rating Scale IV [ADHD-RS-IV] Preschool Version) of ≥30% and a Clinical Global Impression Severity (CGI-S) score of 1 (normal), 2 (borderline ill), or 3 (mildly ill), while maintaining a tolerable adverse event (AE) profile. Once subjects reach an optimal dose of study drug, they will continue on that dose for the remainder of the study.
During titration, if a higher dose is not tolerated, the investigator may reduce the subject's dose by 1 dose level (this may not be done after Week 6 [Visit 8] of the study).
If further dose reductions are required, the subject should be discontinued from the study. Subjects who are unable to tolerate the lowest daily dose (3.1 mg) of study drug will be discontinued from the study.
Subjects who complete the 8-week Treatment Period may be eligible to enter the long-term safety and tolerability study of ADZENYS XR-ODT (NT0202.1010). For subjects to be eligible, they must complete Visit 10 without experiencing any clinically significant AEs that would preclude further exposure to ADZENYS XR-ODT. For subjects entering Study NT0202.1010, Visit 10 of this study can be Visit 1 of Study NT0202.1010, unless more than 2 weeks have elapsed since Visit 10. A safety follow-up telephone call will be made to parents/legal guardians approximately 1 week after discontinuation of study drug for subjects who do not roll over into Study NT0202.1010.
- Conditions
- Attention Deficit Hyperactivity Disorder
- Being tested
- ADZENYS XR-ODT, Placebo Oral Tablet
- Medical subject headings
- Attention Deficit Disorder with Hyperactivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ADZENYS XR-ODTDrug
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.
Placebo Oral TabletDrug
Participants in this arm will be given placebo as matching ODT once daily during the double-blind treatment period.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Placebo Oral Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: Visit 10/Day 56
Secondary outcomes (3)
Clinical Global Impression - Severity
Measured: Visit 10/Day 56
Attention-deficit/hyperactivity disorder Rating Scale-IV Preschool Version Total Score
Measured: Visits 3-9 (Days 7, 14, 21, 28, 35, 42, 49)
Clinical Global Impression - Severity
Measured: Visits 3-9 (Days 7, 14, 21, 28, 35, 42, 49)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Sep 2025
- Study startMay 2019 (estimated)
- Primary completion5 Sep 2025
- Study completion5 Sep 2025
Why it stopped: Enrollment never started
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Placebo-controlled
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- Aytu BioPharma, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Responsible party
- Sponsor
- Investigators
- Carolyn R Sikes, PhD, Study director, Neos Therapeutics, IncAnn Childress, MD, Principal investigator, Center for Psychiatry And Behavioral Medicine Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07169162
- Sponsor's protocol ID
- NT0202.1009
- Status last verified
- Sep 2025
- First submitted
- 5 Sep 2025
- Last updated
- 3 Oct 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 3 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07169162
- Acronym / sponsor ID
- NT0202.1009
- Conditions
- Attention Deficit Hyperactivity Disorder
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Enrollment never started
- Enrolment
- 0 participants (actual)
- Lead sponsor
- Aytu BioPharma, Inc.Industry (pharma, biotech, devices)
- Collaborators
- Premier Research
- Study start
- May 2019 (estimated)
- Primary completion
- 5 Sep 2025 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 11 Sep 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This randomized, double-blind, flexible-dose, placebo-controlled, parallel group study is designed to evaluate the efficacy, safety, and tolerability of ADZENYS XR-ODT compared to placebo in children with ADHD. Male and female children ages 4 to less than 6 years with a diagnosis of ADHD based on Diagnostic and Statistical Manual of Mental Disorders, Fifth Edition (DSM-5) criteria (combined, inattentive, or hyperactive/impulsive) will be enrolled.
A Screening/Washout Period of up to 4 weeks (Days -28 to -1), which will include washout of any current ADHD medications (if applicable), will be followed by an 8-week, Randomized, Double-blind, Flexible-dose Period during which subjects will be randomly assigned to placebo or to ADZENYS XR-ODT once daily. All subjects will start on 3.1 mg of ADZENYS XR-ODT or matching placebo. The dose for each subject will be titrated in a stepwise fashion each week from Visit 3 to Visit 8 (Weeks 1 to 6) based on efficacy and tolerability to 6.3 mg; 9.4 mg; 12.5 mg; 15.7 mg; and 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. Subjects must remain on a stable dose for at least 2 weeks.
An optimal dose is one that produces a reduction from Baseline of ADHD symptoms (ADHD Rating Scale IV [ADHD-RS-IV] Preschool Version) of ≥30% and a Clinical Global Impression Severity (CGI-S) score of 1 (normal), 2 (borderline ill), or 3 (mildly ill), while maintaining a tolerable adverse event (AE) profile. Once subjects reach an optimal dose of study drug, they will continue on that dose for the remainder of the study.
During titration, if a higher dose is not tolerated, the investigator may reduce the subject's dose by 1 dose level (this may not be done after Week 6 [Visit 8] of the study).
If further dose reductions are required, the subject should be discontinued from the study. Subjects who are unable to tolerate the lowest daily dose (3.1 mg) of study drug will be discontinued from the study.
Subjects who complete the 8-week Treatment Period may be eligible to enter the long-term safety and tolerability study of ADZENYS XR-ODT (NT0202.1010). For subjects to be eligible, they must complete Visit 10 without experiencing any clinically significant AEs that would preclude further exposure to ADZENYS XR-ODT. For subjects entering Study NT0202.1010, Visit 10 of this study can be Visit 1 of Study NT0202.1010, unless more than 2 weeks have elapsed since Visit 10. A safety follow-up telephone call will be made to parents/legal guardians approximately 1 week after discontinuation of study drug for subjects who do not roll over into Study NT0202.1010.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Placebo-controlled
| Arm | Type | Receives |
|---|---|---|
| ADZENYS XR-ODT | Experimental | Drug: ADZENYS XR-ODTSubjects 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. |
| Placebo | Placebo comparator | Drug: Placebo Oral TabletParticipants in this arm will be given placebo as matching ODT once daily during the double-blind treatment period. |
Who may qualify
- Ages
- 4 to 5 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (7 listed)
- 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).
Key exclusion criteria (14 listed)
- Other psychiatric diagnoses
- Significant cognitive impairment
- Chronic medical illnesses
- Structural cardiac defects
- Significant abnormal lab tests
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| ADZENYS XR-ODTADZENYS 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 | ADZENYS XR-ODT |
| Placebo Oral TabletParticipants in this arm will be given placebo as matching ODT once daily during the double-blind treatment period. | Drug | Placebo |
Primary outcome
Attention-deficit/hyperactivity disorder Rating Scale-IV Preschool Version Total Score
Time frame: 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
3 secondary outcomes
Clinical Global Impression - Severity
Time frame: Visit 10/Day 56
Attention-deficit/hyperactivity disorder Rating Scale-IV Preschool Version Total Score
Time frame: Visits 3-9 (Days 7, 14, 21, 28, 35, 42, 49)
Clinical Global Impression - Severity
Time frame: Visits 3-9 (Days 7, 14, 21, 28, 35, 42, 49)
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Oct 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Carolyn R Sikes, PhD study director
Neos Therapeutics, Inc
Ann Childress, MD principal investigator
Center for Psychiatry And Behavioral Medicine Inc.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing ADZENYS XR-ODT in people with Attention Deficit Hyperactivity Disorder, run by Aytu BioPharma, Inc. at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: withdrawn, as of the sponsor's last update on 3 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was withdrawn before enrolling participants, so there are no results.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Attention-deficit/hyperactivity disorder Rating Scale-IV Preschool Version Total Score (time frame: Visit 10/Day 56). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 3 Oct 2025.