Ignite Creation Date:
2024-10-26 @ 3:39 PM
Last Modification Date:
2024-10-26 @ 3:39 PM
Study NCT ID:
NCT06577779
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-28
Brief Title:
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
Sponsor:
None
Organization:
None
Study Overview
Official Title:
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
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this study is to extend the efficacy evidence of sustained release methylphenidate compound JornayPM in adults with Attention-deficithyperactivity 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
Detailed Description:
None
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None