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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dyanavel XR (Active Agent) | Active Comparator | Dyanavel 5, 10, 15 or 20 mg once daily in the morning |
|
| Placebo | Placebo Comparator | Matching placebo 5, 10, 15 or 20 mg once daily in the morning |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dyanavel XR | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Fatigue Symptom Inventory (FSI) | Rating scale completed by study coordinator or PI. Score would be 0-10 with 10 being a worse outcome. | Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8 |
| Measure | Description | Time Frame |
|---|---|---|
| Behavior Rating Inventory of Executive Functioning- Adult (BRIEF-A) | Rating scale to assess subject's cognitive functioning. T scores are used to interpret the individual's level of executive functioning, and are derived from their raw scores. T-scores of 65 or over are considered clinically significant. | Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8 |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Jaime Saal, MA | Contact | 2486088800 | 231 | jsaal@rcbm.net |
| Name | Affiliation | Role |
|---|---|---|
| Joel Young, MD | Medical Director | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Rochester Center for Behavioral Medicine | Recruiting | Rochester Hills | Michigan | 48307 | United States |
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8-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.
50 subjects qualifying for a ADHD diagnosis with co-occurring clinically significant fatigue symptoms will be randomized into the trial in two groups to ensure a minimum of 44 subjects completing the trial ( 25 per group, 10% hypothesized attrition rate).
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Only the unblinded pharmacist will be aware of the subject's assigned group for the duration of the study.
|
| Placebo | Drug | 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. |
|
| ADHD Rating Scale (ADHD-RS) | Rating scale to evaluate symptoms of adult ADHD. Scores range from 0-54, with higher scores indicates a worse outcome. | Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8 |
| ADHD Quality of Life Scale (ADHDQOL) | Rating scale to assess quality of life, with possible scores ranging from 0-100. Higher scores are indicative of a better outcome. | Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8 |
| Clinical Global Impression Scales (CGI) | Clinician's subjective rating of subject's severity on a 7-point likert scale from 0-7, with higher scores indicative of a worse outcome. | Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8 |
| Epworth Sleepiness Scale (ESS) | Rating scale to assess level of daytime sleepiness. Scoers range from 0-24 with higher scores indicative of a worse outcome. | Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8 |
| Insomnia Severity Index (ISI) | Rating scale to assess level of insomnia. Scores range from 0-28 with higher scores indicative of a worse outcome. | Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8 |
| Fibromyalgia Impact Questionnaire | Rating scale to assess subject's symptoms of fibromyalgia. Scores can range from 0-80, with higher scores indicative of a worse outcome. | Screening, Baseline, weeks 1, 2, 3, 4, 6 and 8 |
| ID | Term |
|---|---|
| D005221 | Fatigue |
| D001289 | Attention Deficit Disorder with Hyperactivity |
| ID | Term |
|---|---|
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D019958 | Attention Deficit and Disruptive Behavior Disorders |
| D065886 | Neurodevelopmental Disorders |
| D001523 | Mental Disorders |
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| ID | Term |
|---|---|
| D000661 | Amphetamine |
| ID | Term |
|---|---|
| D000662 | Amphetamines |
| D010627 | Phenethylamines |
| D005021 | Ethylamines |
| D000588 | Amines |
| D009930 | Organic Chemicals |
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