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NCT06577779 · ClinicalTrials.gov registry record · Phase 4
An Open-Label Treatment With Randomization Observation, Investigator-Initiated Study, on the Duration and Efficacy of Jornay PM (Methylphenidate Hydrochloride Extended-Release Capsules) on Adult ADHD Symptoms and Executive Function and Emotional Regulation Throughout the Day Into Early Evening
A Phase 4 study of Attention Deficit Hyperactivity Disorder, sponsored by NYU Langone Health.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 30
- Enrollment target
- 1
- Study location
NCT06577779: Recruiting Phase 4 study of Attention Deficit Hyperactivity Disorder, sponsored by NYU Langone Health.
NCT06577779 is a Phase 4 study of Attention Deficit Hyperactivity Disorder that is actively recruiting participants, run by NYU Langone Health. The registered enrollment target is 30 participants, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (86% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT06577779, a Phase 4 study of Attention Deficit Hyperactivity Disorder, is actively recruiting participants, sponsored by NYU Langone Health.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 30 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this study is to extend the efficacy evidence of sustained release methylphenidate compound (JornayPM) in adults with Attention-deficit/hyperactivity disorder (ADHD). JornayPM has recently been approved for treatment of patients 6 years and older with ADHD; the release mechanism is unique among ADHD products in that it is taken in the evening, with effects in the morning upon awakening and then throughout the subsequent day. Of note, to date, there is no clinical data as to the tolerability or clinical effects or dosing in adults with ADHD; therefore the primary aim of this trial is to gather the first set of these data.
Primary Outcome
The expanded AISRS is an 18-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 54; higher scores indicate more severe symptoms of ADHD.
Conditions Studied
Interventions
- DRUG Methylphenidate Hydrochloride Extended Release Capsule
Study Locations (1)
New York
- NYU Langone Health - New York
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 30 participants |
| Start Date | 2025-01-29 |
| Est. Completion | 2026-01 |
| Phase | Phase 4 |
What NCT06577779 shows while recruiting
NCT06577779 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 30 participants, a relatively small participant target, below the 216-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (86% lower).
The record links to 1 condition, with Attention Deficit Hyperactivity Disorder appearing as the primary indexed condition, and to 1 intervention - of which Methylphenidate Hydrochloride Extended Release Capsule is the first listed.
NCT06577779 reports a single indexed study location in New York.
Frequently Asked Questions
What is clinical trial NCT06577779 about?
NCT06577779 is a clinical study titled "An Open-Label Treatment With Randomization Observation, Investigator-Initiated Study, on the Duration and Efficacy of Jornay PM (Methylphenidate Hydrochloride Extended-Release Capsules) on Adult ADHD Symptoms and Executive Function and Emotional Regulation Throughout the Day Into Early Evening". The goal of this study is to extend the efficacy evidence of sustained release methylphenidate compound (JornayPM) in adults with Attention-deficit/hyperactivity disorder (ADHD). JornayPM has recently been approved for treatment of patients 6 years and older with ADHD; the release mechanism is uniqu...
What is the current status of trial NCT06577779?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 30 participants. The study started on 2025-01-29. Estimated completion is 2026-01.
What conditions does trial NCT06577779 study?
This clinical trial studies the following conditions: Attention Deficit Hyperactivity Disorder.
What interventions are being tested in trial NCT06577779?
The interventions under investigation include: Methylphenidate Hydrochloride Extended Release Capsule (DRUG).
Who is sponsoring clinical trial NCT06577779?
This trial is sponsored by NYU Langone Health, which has 1,164 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06577779 being conducted?
This trial has 1 study location across New York. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
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Where NCT06577779's enrollment target sits among peer trials
30 81st of 102 higher than 14 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder 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.
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