Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
NCT06000501 · ClinicalTrials.gov registry record · Phase 4
Duration and Efficacy of Azstarys on Adult ADHD Symptoms and Executive Function in Early Evening
A Phase 4 study, sponsored by NYU Langone Health.
- Completed
- Registry status
- Phase 4
- Development phase
- 29
- Enrollment target
NCT06000501: Completed Phase 4 study, sponsored by NYU Langone Health.
NCT06000501 is a Phase 4 study that has completed, run by NYU Langone Health. The registered enrollment target is 29 participants, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower). According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06000501, a Phase 4 study, has completed, sponsored by NYU Langone Health.
- COMPLETED
- Registry status
- Phase 4
- Development phase
- 29 participants
- Enrollment target
Study 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).
Primary Outcome
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.
Interventions
- DRUG Serdexmethylphenidate/dexmethylphenidate
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 29 participants |
| Start Date | 2023-11-13 |
| Est. Completion | 2024-07-17 |
| Phase | Phase 4 |
What the finished NCT06000501 record still lists
NCT06000501 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 29 participants, a relatively small participant target, below the 518-participant average among 9,235 other Phase 4 trials with a reported enrollment target (94% lower).
The record links to 0 conditions, and to 1 intervention - of which Serdexmethylphenidate/dexmethylphenidate is the first listed.
NCT06000501 does not publish any study locations in the registry export this page uses.
Frequently Asked Questions
What is clinical trial NCT06000501 about?
NCT06000501 is a clinical study titled "Duration and Efficacy of Azstarys 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 AD...
What is the current status of trial NCT06000501?
This trial is currently completed. It is a Phase 4 study. The enrollment target is 29 participants. The study started on 2023-11-13. Estimated completion is 2024-07-17.
What interventions are being tested in trial NCT06000501?
The interventions under investigation include: Serdexmethylphenidate/dexmethylphenidate (DRUG).
Who is sponsoring clinical trial NCT06000501?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Learn More About Clinical Trials
How this trial's enrollment target compares
Where NCT06000501's enrollment target sits among peer trials
29 1634th of 2000 higher than 366 of 2,000 other Phase 4 trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Phase 4 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
Source ClinicalTrials.gov registry export · 2026-08-08
Nationwide trials with similar profiles
Cross-condition peers matched on enrollment target and registry start date, not the same-condition list above.
Similar enrollment target
- NCT02429557 · 29 participants · Phase 1
Hemodynamic Mechanisms of Abdominal Compression in the Treatment of Orthostatic Hypotension in Autonomic Failure
- NCT02568878 · 29 participants · Phase 3
Creatine for Depressed Male and Female Methamphetamine Users
- NCT03014401 · 29 participants · NA
The Effect of Adipose-Derived Stem Cells for Knee Osteoarthritis
- NCT03128996 · 29 participants · Phase 1
Reduced Intensity Conditioning and Familial HLA-Mismatched BMT for Non-Malignant Disorders
Similar registry start date
- NCT05962346 · started 2026-12 · NA
Fetal Endoscopic Tracheal Occlusion for Congenital Diaphragmatic Hernia
- NCT07125183 · started 2026-12 · Phase 2
Study on Efficacy and Tolerability of Weekly Doxorubicin in Elderly Patients With Advanced or Metastatic Leiomyosarcoma
- NCT07292298 · started 2026-11 · Phase 2
Phase 2 Single-Arm Rectal Cancer Brachytherapy for Patients With Low-Lying Residual Adenocarcinoma After Total Neoadjuvant Therapy to Improve Organ Preservation Rates
- NCT04263285 · started 2026-10 · NA
Treatment of Depression Post-SCI