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

NCT06000501 | Completed Phase 4 Results FDA Drug

• 1 other identifier: 22-01003
• Study Type: interventional
• Target: 29
• Locations: 1 country
• Sites: 1

Brief 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 Symptom Rating Scale. The investigators will also examine Executive Function later in the day (early evening, about 12 hours after first morning dosing).

Conditions

Adult Attention Deficit Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (34)

• Change in Expanded AISRS - Overall Inattentive (IA) Subscale Score

  Week 2, Week 5

• Change in Expanded AISRS - Hyperactive/Impulsive (HI) Subscale Score

  Week 2, Week 5

• Change in Expanded AISRS - Overall Executive Dysfunction (EFD) Subscale Score

  Week 2, Week 5

• Change in Expanded AISRS - Overall Emotional Control (EC) Subscale Score

  Week 2, Week 5

• Change in Adult ADHD Self Report Scale (ASRS) Symptom Checklist DSM-5 Expanded Score

  Week 2, Week 5

Study Arms (1)

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.

Drug: Serdexmethylphenidate/dexmethylphenidate

Interventions

Serdexmethylphenidate/dexmethylphenidate DRUG

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.

Also known as: Azstarys

Adult ADHD Patients

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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

Sponsors & Collaborators

• NYU Langone Health: lead
• Corium, Inc.: collaborator

Study Sites (1)

NYU Langone Health

New York, New York, 10016, United States

Location

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Interventions

serdexmethylphenidate and dexmethylphenidate

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Results Point of Contact

• Title: Lenard Adler, MD
• Organization: NYU Langone Health

Lenard.Adler@nyulangone.org

212-263-3580

Study Officials

• Lenard Adler

  NYU Langone Health

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 14, 2023
• First Posted: August 21, 2023
• Study Start: November 13, 2023
• Primary Completion: July 3, 2024
• Study Completion: July 17, 2024
• Last Updated: July 29, 2025
• Results First Posted: July 29, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)