NCT06248229

A Trial of Dyanavel XR in Treating Co-occurring Fatigue Symptoms in Adults With Attention Deficit Hyperactivity Disorder (ADHD).

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 Deficit/Hyperactivity Disorder (ADHD)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 50 (estimated)
• Sponsor: Rochester Center for Behavioral Medicine · Academic / Other
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Accepted

Summary

The goal of this clinical trial is to study the impact of Dyanavel on co-occuring fatigue in adults with Attention Deficit/Hyperactivity 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 (1:1) 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.

Conditions

• Fatigue
• Attention Deficit Hyperactivity Disorder
• Attention Deficit Disorder

Interventions

Type	Name	Description
DRUG	Dyanavel XR	Dosing will begin the morning following Visit 2. Subjects in the active group will begin the study on 5 mg of Dyanavel XR. Subjects will be advised to take one capsule each morning upon awakening, dosed consistently with respect to time. Subjects will be advised that tablets should be swallowed whole, not crushed, chewed, or cut. Subjects can take Dyanavel XR with or without food. Subjects will return to the study site on a weekly (and later, bi-weekly) basis for evaluation of symptoms and possible side effects. Subjects will be titrated to their optimal dose based on the dose titration schedule displayed in Section 5.1. The PI will be available to consult with patients as needed between Week 0 and Week 4 to adjust dosage per the PI's clinical judgment.
DRUG	Placebo	Dosing will begin the morning following Visit 2. Subjects in the placebo group will begin the study on 5 mg of placebo. Subjects will be advised to take one tablet each morning upon awakening, dosed consistently with respect to time. Subjects will be advised that tablets should be swallowed whole, not crushed, chewed, or cut. Subjects can take Dyanavel XR with or without food. Subjects will return to the study site on a weekly (and later, bi-weekly) basis for evaluation of symptoms and possible side effects. Subjects will be titrated to their optimal dose based on the dose titration schedule displayed in Section 5.1. The PI will be available to consult with patients as needed between Week 0 and Week 4 to adjust dosage per the PI's clinical judgment.

Timeline

• Start date: 2024-09-01
• Primary completion: 2026-09-01
• Completion: 2026-12-01
• First posted: 2024-02-08
• Last updated: 2024-11-21

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study