NCT06000501

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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 29 (actual)
• Sponsor: NYU Langone Health · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2023-11-13
• Primary completion: 2024-07-03
• Completion: 2024-07-17
• First posted: 2023-08-21
• Last updated: 2025-07-29
• Results posted: 2025-07-29

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study