drugset / Trial / NCT06000501

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

NCT06000501 ↗

Phase 4 Completed 29 enrolled NYU Langone Health Corium, Inc. · collab
NaSingle-groupOpen-labelTreatment

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).

Timeline

Start
2023-11-13
Primary completion
2024-07-03
Completion
2024-07-17

Drugs

EvaluationDrugModalityDoseRoute
Subject Serdexmethylphenidate/dexmethylphenidate Unknown 10.4 mg Oral
Subject Serdexmethylphenidate/dexmethylphenidate Unknown 52.3 mg Oral