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

NCT ID: NCT06000501

Last Updated: 2025-07-29

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 29 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-11-13
• Study Completion Date: 2024-07-17

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

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Serdexmethylphenidate/dexmethylphenidate

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Other Intervention Names

Azstarys

Eligibility Criteria

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.

• 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

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Corium, Inc.

INDUSTRY

Sponsor Role: collaborator

NYU Langone Health

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Lenard Adler

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

NYU Langone Health

New York, New York, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

22-01003

Identifier Type: -

Identifier Source: org_study_id