Study of Flexible Dosing of Dyanavel XR for Treating Fatigue in Adults with ADHD in a 10-Week Randomized, Double-Blind Trial

What this Trial Is About

Researchers are studying the impact of Dyanavel XR on fatigue in adults diagnosed with Attention DeficitHyperactivity Disorder ADHD. This clinical trial aims to determine if Dyanavel XR can reduce fatigue symptoms compared to a placebo. The study uses a randomized, double-blind, placebo-controlled design with flexible dosing over a 10-week period. Participants will be randomly assigned to receive either Dyanavel XR or a matching placebo, starting at 5 mg once daily in the morning. Dosage may be adjusted weekly or bi-weekly based on individual response and side effects, with the investigator available to guide dosing between Weeks 0 and 4. Tablets should be swallowed whole and can be taken with or without food. Throughout the study, participants will attend regular visits for symptom evaluation and side effect monitoring. Various assessments, including the Fatigue Symptom Inventory, Behavior Rating Inventory of Executive Functioning-Adult, ADHD Rating Scale, and other quality of life and sleep questionnaires, will be conducted at screening, baseline, and multiple weeks during treatment. Safety and efficacy will be closely monitored, and the study is expected to conclude by December 2026.

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