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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 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 297-participant average among 13 other Attention Deficit/Hyperactivity Disorder trials with a reported enrollment target (90% lower). The trial reports 1 study location across 1 state.
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.
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 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06577779
The ClinicalTrials.gov registry entry for NCT06577779 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 30 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 297-participant average among 13 other Attention Deficit/Hyperactivity Disorder trials with a reported enrollment target (90% lower). The listed sponsor is NYU Langone Health, which has 1,164 total studies on file at ClinicalTrials.gov.
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 1 study location spanning 1 distinct geographic area - top geographies include 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.
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Read our methodology - how this data is sourced, computed, and verified.
Related
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