Ignite Creation Date:
2024-05-06 @ 8:04 PM
Last Modification Date:
2024-10-26 @ 3:20 PM
Study NCT ID:
NCT06248229
Status:
NOT_YET_RECRUITING
Last Update Posted:
2024-07-05
First Post:
2024-01-31
Brief Title:
A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder ADHD
Sponsor:
Rochester Center for Behavioral Medicine
Organization:
Rochester Center for Behavioral Medicine
Study Overview
Official Title:
A Single Center Flexible-Dose 10-Week Randomized Double-Blinded Placebo-Controlled Clinical Trial To Study The Efficacy Of Dyanavel XR In Treating Co-Occurring Fatigue In Adults With Attention DeficitHyperactivity Disorder ADHD
Status:
NOT_YET_RECRUITING
Status Verified Date:
2024-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The goal of this clinical trial is to study the impact of Dyanavel on co-occuring fatigue in adults with Attention DeficitHyperactivity Disorder The main question it aims to answer is whether Dyanavel XR leads to a statistically significant reduction in fatigue compared to placebo as measured by the Fatigue Symptom Inventory
Detailed Description:
10-week single center randomized double-blind placebo-controlled flexible titration trial evaluating the efficacy of Dyanavel Dyanavel XR XR in the treatment of fatigue symptoms in adult subjects with a diagnosis of ADHD Subjects will be randomly assigned 11 to a Dyanavel Dyanavel XR XR flexible titration dosing group n 22 to 25 or placebo group n 22 to 25 The study will utilize an intent to treat model and impute data if statistically feasible from dropouts utilizing a MNAR missing not at random approach
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
True
Is an FDA AA801 Violation?:
None