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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

StatusRecruiting
PhasePhase 4
Started2025-01-29
View on ClinicalTrials.gov ↗
Record status
This record was last updated April 29, 2026 (before its estimated June 30, 2026 completion). Its status may not reflect the trial's current state.

Amendment history

2026-04-27
minor
Study Status v2
Primary completion date2025-12-30→2026-06-30
Completion date2026-01→2026-10-30
2025-06-23
minor
Study Status v1
Primary completion date2025-07-30→2025-12-30
Completion date2025-10→2026-01
Start date2024-08-19→2025-01-29
2024-08-28
minor
Original filing
385 trials monitored
See 19 trials at risk
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.
Trial Details
NCT Number NCT06577779
Lead Sponsor NYU Langone Health
Conditions Attention-deficit/Hyperactivity Disorder
Enrollment 30 participants
Start Date 2025-01-29
Primary Completion 2026-06-30 (estimated)
Study Completion 2026-10-30 (estimated)
Updated on ClinicalTrials.gov 2026-04-29