Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening

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).

Study Overview

• Status: Completed
• Conditions: Adult Attention Deficit Hyperactivity Disorder
• Intervention / Treatment: Drug: Serdexmethylphenidate/dexmethylphenidate

• Study Type: Interventional
• Enrollment (Actual): 29
• Phase: Phase 4

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10016
      • NYU Langone Health

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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
• 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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Adult ADHD Patients; 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.

Drug: Serdexmethylphenidate/dexmethylphenidate; 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.; Other Names: Azstarys

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	Week 2, Week 5

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	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.	Week 2, Week 5

Collaborators and Investigators

• Sponsor: NYU Langone Health
• Collaborators: Corium, Inc.
• Investigators: Principal Investigator: Lenard Adler, NYU Langone Health

Study record dates

Study Major Dates

• Study Start (Actual): November 13, 2023
• Primary Completion (Actual): July 3, 2024
• Study Completion (Actual): July 17, 2024

Study Registration Dates

• First Submitted: August 14, 2023
• First Submitted That Met QC Criteria: August 18, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): July 29, 2025
• Last Update Submitted That Met QC Criteria: July 28, 2025
• Last Verified: July 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Attention Deficit Disorder with Hyperactivity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Central Nervous System Stimulants; Dopamine Uptake Inhibitors; Neurotransmitter Uptake Inhibitors; Dopamine Agents; Dexmethylphenidate Hydrochloride
• Other Study ID Numbers: 22-01003

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No