Adult Attention Deficit Hyperactivity DisorderPhase 4NCT06000501
Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening
A Phase 4 study testing Serdexmethylphenidate/dexmethylphenidate in people with Adult Attention Deficit Hyperactivity Disorder, run by NYU Langone Health at 1 site in United States.
Trial summary
This is a single-site study. One purpose of this trial is to extend the safety and efficacy evidence basis for Azstarys in adults with ADHD. This open-label, treatment study will examine the efficacy of Azstarys on ADHD symptoms using the AISRS 18-item total score on the AISRS-expanded; the Adult ADHD Investigator… Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Adult Attention Deficit Hyperactivity Disorder
- What is being tested?
- Serdexmethylphenidate/dexmethylphenidate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Nov 2023to 17 Jul 2024
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults ages 18-60 years, inclusive at the time of consent
- Able to provide signed informed consent
- Any gender
- Subjects with a current primary DSM-5 diagnosis of ADHD of predominantly inattentive presentation, or combined presentations) as confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) Version 1.2.5, Subjects who are not receiving any pharmacological treatment for ADHD must have an AISRS 18 item total score of AISRS expanded of ≥ 28 at screening. Subjects who were previously receiving pharmacological treatment for ADHD at screening must have a minimum total AISRS 18 item of AISRS EXPANDED score of ≥ 22 at screening
- Dysthymia and anxiety disorders in remission but stable on psychiatric medication for three weeks or more at the discretion of principal investigator will be allowed- medication for these disorders to remain constant for the duration of the protocol.
- Subjects who are stimulant naïve.
Who cannot join
- Known hypersensitivity to serdexmethylphenidate, methylphenidate, or product components.
- Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days.
- Lifetime bipolar disorder, psychotic disorders, autism, intellectual disability except mood disorders accepted under the inclusion criteria at the discretion of the principal investigator.
- Active suicidality within past year, or history of suicide attempt in past 2 years
- Any history of severe past drug dependence determined by the MINI (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty)
- Concurrent substance abuse and/or history of substance use within 6 months
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- Use of any prescribed benzodiazepine
- Any unstable medical or neurological condition; clinically significant medical abnormalities such as cardiovascular abnormalities, and any chronic condition of the central nervous system.
- Any psychotropic medication usage
- Known nonresponse to MPH treatment
- History of allergic reaction or sensitivity to MPH
- Female of childbearing age, who are breastfeeding, pregnant, planning to be pregnant or men planning to make a woman pregnant during the study or for one-month post study
- PI/clinician discretion
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-Label Treatment, Investigator-Initiated Study, on the Duration and Efficacy of Azstarys (Serdexmethylphenidate and Dexmethylphenidate) on Adult ADHD Symptoms and Executive Function in Early Evening
This is a single-site study. One purpose of this trial is to extend the safety and efficacy evidence basis for Azstarys in adults with ADHD. This open-label, treatment study will examine the efficacy of Azstarys on ADHD symptoms using the AISRS 18-item total score on the AISRS-expanded; the Adult ADHD Investigator Symptom Rating Scale. The investigators will also examine Executive Function later in the day (early evening, about 12 hours after first morning dosing).
- Being tested
- Serdexmethylphenidate/dexmethylphenidate
- 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.
Serdexmethylphenidate/dexmethylphenidateDrug
Also called Azstarys
Azstarys capsules for once-daily oral use for three weeks. Flexible dose starting at 39.2 mg serd-mph/7.8 mg d-mph and moving up to 52.3 mg serd-mph/10.4 mg d-mph.
| Study group | Role | What they receive |
|---|---|---|
| Adult ADHD Patients | Experimental | Enrolled participants will begin with a two-week observation stabilization before starting treatment with Azstarys. Participants found to have ≥30% change in their total Adult ADHD Investigator Symptom Rating Scale (AISRS) scores during the two-week observation stabilization period treatment will be discontinued from the study. Remaining participants will be dispensed a three-week supply of Azstarys on a weekly basis. Receives: Drug: Serdexmethylphenidate/dexmethylphenidate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score
The expanded AISRS is an 34-item questionnaire assessing symptoms of adult ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 102; higher scores indicate more severe symptoms of ADHD.
Measured: Week 2, Week 5
Secondary outcomes (34)
Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
The expanded AISRS is an 34-item questionnaire assessing symptoms of adult ADHD. The 9-item subscale of the AISRS assessing inattentive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater overall inattentive symptoms.
Measured: Week 2, Week 5
Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
The expanded AISRS is an 34-item questionnaire assessing symptoms of adult ADHD. The 9-item subscale of the AISRS assessing hyperactive/impulsive symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater hyperactive/impulsive symptoms.
Measured: Week 2, Week 5
Change in Expanded AISRS - Overall Executive Dysfunction (EFD) Subscale Score
The expanded AISRS is an 34-item questionnaire assessing symptoms of adult ADHD. The 9-item subscale of the AISRS assessing executive dysfunction symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater hyperactive/impulsive symptoms.
Measured: Week 2, Week 5
Change in Expanded AISRS - Overall Emotional Control (EC) Subscale Score
The expanded AISRS is an 34-item questionnaire assessing symptoms of adult ADHD. The 9-item subscale of the AISRS assessing emotional control symptoms of ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 27; higher scores indicate greater hyperactive/impulsive symptoms.
Measured: Week 2, Week 5
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist DSM-5 Expanded Score
The ASRS is a 31-item questionnaire that assesses the frequency of ADHD symptoms over the past 7 days. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The ASRS includes several subscales: an Inattentive (IA) subscale (n = 9), a Hyperactive-Impulsive (HI) subscale (n = 9), an Executive Function Deficits (EFD) subscale (n = 9), and an Emotional Dyscontrol (ED) subscale (n = 4). It also yields a total combined ADHD symptom score. The total score is calculated as the sum of all item responses and ranges from 0 to 124, with higher scores indicating greater frequency of ADHD symptoms.
Measured: Week 2, Week 5
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Inattentive (IA) Subscale Score
The ASRS is a 31-item questionnaire that assesses the frequency of ADHD symptoms over the past 7 days. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The ASRS includes several subscales: an Inattentive (IA) subscale (n = 9), a Hyperactive-Impulsive (HI) subscale (n = 9), an Executive Function Deficits (EFD) subscale (n = 9), and an Emotional Dyscontrol (ED) subscale (n = 4). It also yields a total combined ADHD symptom score. The IA score ranges from 0-36. Higher scores indicating greater symptom severity.
Measured: Week 2, Week 5
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Hyperactive (HI) Subscale Score
The ASRS is a 31-item questionnaire that assesses the frequency of ADHD symptoms over the past 7 days. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The ASRS includes several subscales: an Inattentive (IA) subscale (n = 9), a Hyperactive-Impulsive (HI) subscale (n = 9), an Executive Function Deficits (EFD) subscale (n = 9), and an Emotional Dyscontrol (ED) subscale (n = 4). It also yields a total combined ADHD symptom score. The HI score ranges from 0-36. Higher scores indicating greater symptom severity.
Measured: Week 2, Week 5
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Executive Dysfunction (EFD) Subscale Score
The ASRS is a 31-item questionnaire that assesses the frequency of ADHD symptoms over the past 7 days. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The ASRS includes several subscales: an Inattentive (IA) subscale (n = 9), a Hyperactive-Impulsive (HI) subscale (n = 9), an Executive Function Deficits (EFD) subscale (n = 9), and an Emotional Dyscontrol (ED) subscale (n = 4). It also yields a total combined ADHD symptom score. The EFD score ranges from 0-36. Higher scores indicating greater symptom severity.symptoms.
Measured: Week 2, Week 5
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score Overall Emotional Dyscontrol (ED) Subscale Score
The ASRS is a 31-item questionnaire that assesses the frequency of ADHD symptoms over the past 7 days. Items are rated on a 5-point Likert scale ranging from 0 (never) to 4 (very often). The ASRS includes several subscales: an Inattentive (IA) subscale (n = 9), a Hyperactive-Impulsive (HI) subscale (n = 9), an Executive Function Deficits (EFD) subscale (n = 9), and an Emotional Dyscontrol (ED) subscale (n = 4). It also yields a total combined ADHD symptom score. The ED score ranges from 0-36. Higher scores indicating greater symptom severity.
Measured: Week 2, Week 5
Change in 1-Hour Post-Dose Time-Sensitive ADHD Symptom Scale (TASS) Score
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Measured: Week 2, Week 5
Change in 4-Hour Post-Dose TASS Score
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Measured: Week 2, Week 5
Change in 12-Hour Post-Dose TASS Score
18-item assessment of ADHD symptoms. Each item is rated on a 4-point Likert scale from 0 (not at all) to 3 (severe). The total score is the sum of responses and ranges from 0 to 54; higher scores indicate greater severity of symptoms.
Measured: Week 2, Week 5
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 4-Hour Post Dose Score
AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Measured: Week 3
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 6-Hour Post Dose Score
AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Measured: Week 3
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 8-Hour Post Dose Score
AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Measured: Week 3
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 10-Hour Post Dose Score
AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Measured: Week 3
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 12-Hour Post Dose Score
AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Measured: Week 3
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 4-Hour Post Dose Score
AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Measured: Week 4
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 6-Hour Post Dose Score
AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Measured: Week 4
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 8-Hour Post Dose Score
AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Measured: Week 4
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 10-Hour Post Dose Score
AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Measured: Week 4
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 12-Hour Post Dose Score
AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Measured: Week 4
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 4-Hour Post Dose Score
AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Measured: Week 5
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 6-Hour Post Dose Score
AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Measured: Week 5
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 8-Hour Post Dose Score
AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Measured: Week 5
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 10-Hour Post Dose Score
AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Measured: Week 5
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 12-Hour Post Dose Score
AMSES is used to assess the smoothness of effect of ADHD medication at specified timepoints throughout the day (4, 6, 8, 10, and 12 hours after dosing). At each timepoint, participants are asked to rate whether the medication's effect feels the same as when they first took it in the morning, using a 5-point Likert scale ranging from 0 (never) to 4 (very often). Higher scores indicate greater smoothness of medication effect.
Measured: Week 5
AMSES - Overall Smoothness of Effect Scale Score
AMSES is is an assessment of the smoothness of effect of ADHD medication throughout the day following dosing. The overall smoothness of effect scale is a subscale part of the AMSES that asks participants to respond to "How smooth do you think your medication effect is throughout the day?" on a scale from 0 (never) to 100 (very often). The higher the score, the smoother the medication effect is throughout the day.
Measured: Week 3
AMSES - Overall Smoothness of Effect Scale Score
AMSES is an assessment of the smoothness of effect of ADHD medication throughout the day following dosing. The overall smoothness of effect scale is a subscale part of the AMSES that asks participants to respond to "How smooth do you think your medication effect is throughout the day?" on a scale from 0 (never) to 100 (very often). The higher the score, the smoother the medication effect is throughout the day.
Measured: Week 4
AMSES - Overall Smoothness of Effect Scale Score
AMSES is an assessment of the smoothness of effect of ADHD medication throughout the day following dosing. The overall smoothness of effect scale is a subscale part of the AMSES that asks participants to respond to "How smooth do you think your medication effect is throughout the day?" on a scale from 0 (never) to 100 (very often). The higher the score, the smoother the medication effect is throughout the day.
Measured: Week 5
Change in Behavioral Regulation Index (BRI) T-Score
The Behavioral Regulation Index (BRI) t-score on the BRIEF-A (Behavior Rating Inventory of Executive Function-Adult Version) is a summary measure of an individual's ability to regulate their behavior and emotions, 50 indicates the population mean with a standard deviation of 10. A t-score of 65 or higher indicates difficulties in behavioral regulation.
Measured: Week 2, Week 5
Change in Metacognition Index (MI) T-Score
The Metacognition Index (MI) t-score on the BRIEF-A (Behavior Rating Inventory of Executive Function-Adult Version) is a measure of executive function that assesses an individual's ability to initiate, plan, organize, self-monitor, and manage their own cognitive processes, 50 indicates the population mean with a standard deviation of 10. A t-score of 65 or higher indicates difficulties with executive function related to planning, organization, and cognitive self-regulation.
Measured: Week 2, Week 5
Change in Global Executive Composite (GEC) T-score
The Global Executive Composite (GEC) t-score on the BRIEF-A (Behavior Rating Inventory of Executive Function-Adult Version) is a summary measure of overall executive function, 50 indicates the population mean with a standard deviation of 10. A t-score of 65 or higher indicates difficulties with executive function in daily life.
Measured: Week 2, Week 5
Change in Clinical Global Impression-Severity (CGI-S) Scale Score
1-item clinician-rated assessment of the severity of a subject's mental illness. The severity of illness is rated as follows: 0 (not assessed), 1 (normal, not at all ill), 2 (borderline mentally ill), 3 (mildly ill), 4 (moderately ill), 5 (markedly ill), 6 (severely ill), 7 (among the most extremely ill subjects). The total score is the numerical ranking provided by the clinician.
Measured: Week 2, Week 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Aug 2023
- Study start13 Nov 2023
- Primary completion3 Jul 2024
- Study completion17 Jul 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Adult Attention Deficit Hyperactivity DisorderStudies of the same condition, open and under way.
- More trials run by NYU Langone HealthThe sponsor's other registered studies.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- NYU Langone Health
- Sponsor type
- University, hospital or other
- Collaborators
- Corium, Inc.
- Responsible party
- Sponsor
- Investigators
- Lenard Adler, Principal investigator, NYU Langone Health
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06000501
- Sponsor's protocol ID
- 22-01003
- Status last verified
- Jul 2025
- First submitted
- 14 Aug 2023
- Last updated
- 29 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: The study protocol, statistical analysis plan, outcome measure results and adverse event data will be made available on ClinicalTrials.gov. IPD will not be shared due to capacity constraints and privacy concerns.
Study at a glance
From the registry record, last updated by the sponsor on 29 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Treatment, Investigator-Initiated Study, on the Duration and Efficacy of Azstarys (Serdexmethylphenidate and Dexmethylphenidate) on Adult ADHD Symptoms and Executive Function in Early Evening
- ClinicalTrials.gov ID
- NCT06000501
- Acronym / sponsor ID
- 22-01003
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- NYU Langone HealthUniversity, hospital or other
- Collaborators
- Corium, Inc.
- Study start
- 13 Nov 2023 (actual)
- Primary completion
- 3 Jul 2024 (actual)
- Study completion
- 17 Jul 2024 (actual)
- First posted
- 21 Aug 2023 (actual)
- Results
- Posted 29 Jul 2025
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 single-site study. One purpose of this trial is to extend the safety and efficacy evidence basis for Azstarys in adults with ADHD. This open-label, treatment study will examine the efficacy of Azstarys on ADHD symptoms using the AISRS 18-item total score on the AISRS-expanded; the Adult ADHD Investigator Symptom Rating Scale. The investigators will also examine Executive Function later in the day (early evening, about 12 hours after first morning dosing).
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adult ADHD Patients | Experimental | Drug: Serdexmethylphenidate/dexmethylphenidateEnrolled participants will begin with a two-week observation stabilization before starting treatment with Azstarys. Participants found to have ≥30% change in their total Adult ADHD Investigator Symptom Rating Scale (AISRS) scores during the two-week observation stabilization period treatment will be discontinued from the study. Remaining participants will be dispensed a three-week supply of Azstarys on a weekly basis. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Adults ages 18-60 years, inclusive at the time of consent
- Able to provide signed informed consent
- Any gender
- Subjects with a current primary DSM-5 diagnosis of ADHD of predominantly inattentive presentation, or combined presentations) as confirmed by the Adult ADHD Clinical Diagnostic Scale (ACDS) Version 1.2.5, Subjects who are not receiving any pharmacological treatment for ADHD must have an AISRS 18 item total score of AISRS expanded of ≥ 28 at screening. Subjects who were previously receiving pharmacological treatment for ADHD at screening must have a minimum total AISRS 18 item of AISRS EXPANDED score of ≥ 22 at screening
- Dysthymia and anxiety disorders in remission but stable on psychiatric medication for three weeks or more at the discretion of principal investigator will be allowed- medication for these disorders to remain constant for the duration of the protocol.
Key exclusion criteria (13 listed)
- Known hypersensitivity to serdexmethylphenidate, methylphenidate, or product components.
- Concurrent treatment with a monoamine oxidase inhibitor (MAOI), or use of an MAOI within the preceding 14 days.
- Lifetime bipolar disorder, psychotic disorders, autism, intellectual disability except mood disorders accepted under the inclusion criteria at the discretion of the principal investigator.
- Active suicidality within past year, or history of suicide attempt in past 2 years
- Any history of severe past drug dependence determined by the MINI (i.e., a focus of clinical attention or a cause of substantial social or occupational difficulty)
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 |
|---|---|---|
| Serdexmethylphenidate/dexmethylphenidateAlso: AzstarysAzstarys capsules for once-daily oral use for three weeks. Flexible dose starting at 39.2 mg serd-mph/7.8 mg d-mph and moving up to 52.3 mg serd-mph/10.4 mg d-mph. | Drug | Adult ADHD Patients |
Primary outcome
Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score
Time frame: Week 2, Week 5
The expanded AISRS is an 34-item questionnaire assessing symptoms of adult ADHD. Items are ranked on a 4-point Likert scale ranging from 0 (none) to 3 (severe). The total score is the sum of responses and ranges from 0 to 102; higher scores indicate more severe symptoms of ADHD.
34 secondary outcomes
Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score
Time frame: Week 2, Week 5
Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score
Time frame: Week 2, Week 5
Change in Expanded AISRS - Overall Executive Dysfunction (EFD) Subscale Score
Time frame: Week 2, Week 5
Change in Expanded AISRS - Overall Emotional Control (EC) Subscale Score
Time frame: Week 2, Week 5
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist DSM-5 Expanded Score
Time frame: Week 2, Week 5
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Inattentive (IA) Subscale Score
Time frame: Week 2, Week 5
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Hyperactive (HI) Subscale Score
Time frame: Week 2, Week 5
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Executive Dysfunction (EFD) Subscale Score
Time frame: Week 2, Week 5
Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist Score Overall Emotional Dyscontrol (ED) Subscale Score
Time frame: Week 2, Week 5
Change in 1-Hour Post-Dose Time-Sensitive ADHD Symptom Scale (TASS) Score
Time frame: Week 2, Week 5
Change in 4-Hour Post-Dose TASS Score
Time frame: Week 2, Week 5
Change in 12-Hour Post-Dose TASS Score
Time frame: Week 2, Week 5
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 4-Hour Post Dose Score
Time frame: Week 3
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 6-Hour Post Dose Score
Time frame: Week 3
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 8-Hour Post Dose Score
Time frame: Week 3
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 10-Hour Post Dose Score
Time frame: Week 3
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 12-Hour Post Dose Score
Time frame: Week 3
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 4-Hour Post Dose Score
Time frame: Week 4
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 6-Hour Post Dose Score
Time frame: Week 4
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 8-Hour Post Dose Score
Time frame: Week 4
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 10-Hour Post Dose Score
Time frame: Week 4
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 12-Hour Post Dose Score
Time frame: Week 4
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 4-Hour Post Dose Score
Time frame: Week 5
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 6-Hour Post Dose Score
Time frame: Week 5
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 8-Hour Post Dose Score
Time frame: Week 5
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 10-Hour Post Dose Score
Time frame: Week 5
Adult ADHD Medication Smoothness of Effect Scale (AMSES) - 12-Hour Post Dose Score
Time frame: Week 5
AMSES - Overall Smoothness of Effect Scale Score
Time frame: Week 3
AMSES - Overall Smoothness of Effect Scale Score
Time frame: Week 4
AMSES - Overall Smoothness of Effect Scale Score
Time frame: Week 5
Change in Behavioral Regulation Index (BRI) T-Score
Time frame: Week 2, Week 5
Change in Metacognition Index (MI) T-Score
Time frame: Week 2, Week 5
Change in Global Executive Composite (GEC) T-score
Time frame: Week 2, Week 5
Change in Clinical Global Impression-Severity (CGI-S) Scale Score
Time frame: Week 2, Week 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No. The study protocol, statistical analysis plan, outcome measure results and adverse event data will be made available on ClinicalTrials.gov. IPD will not be shared due to capacity constraints and privacy concerns.
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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.
Lenard Adler principal investigator
NYU Langone Health
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 Serdexmethylphenidate/dexmethylphenidate in people with Adult Attention Deficit Hyperactivity Disorder, run by NYU Langone Health 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 6 inclusion and 13 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: finished, as of the sponsor's last update on 29 Jul 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. 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?
Yes. Results are posted in the registry (first posted 29 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change in Expanded Adult ADHD Investigator Symptom Rating Scale (AISRS) Total Score (time frame: Week 2, Week 5). 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 29 Jul 2025.