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Stimulant
Dyanavel XR for ADHD and Fatigue
Rochester Hills, MI
Phase 4
Recruiting
Led By Joel Young, MD
Research Sponsored by Rochester Center for Behavioral Medicine
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
At screening, all subjects must have a Fatigue Symptom Inventory average score on both of the interference and severity scales greater than 3.
All subjects must be 18-65 years of age at the time of consent.
Timeline
Screening 3 weeks
Treatment Varies
Follow Up screening, baseline, weeks 1, 2, 3, 4, 6 and 8
Awards & highlights
Drug Has Already Been Approved
Pivotal Trial
Summary
This trial aims to see if Dyanavel can help reduce fatigue in adults with ADHD. It will compare the effects of Dyanavel XR to a placebo to see if there is a significant difference in
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Who is the study for?
Adults aged 18-65 with ADHD and significant fatigue living in or near Michigan, who can swallow tablets and follow the study plan. They must score high on specific ADHD and fatigue scales, have no major intellectual deficits, agree to use two birth control methods if applicable, and sign informed consent.Check my eligibility
What is being tested?
The trial is testing whether Dyanavel XR reduces fatigue in adults with ADHD more effectively than a placebo. Participants will be randomly assigned to receive either Dyanavel XR or a placebo, and their levels of fatigue will be measured using the Fatigue Symptom Inventory.See study design
What are the potential side effects?
Possible side effects of Dyanavel XR include nervousness, trouble sleeping, loss of appetite, weight loss, dizziness, stomach pain, headache or fast heart rate. Side effects vary from person to person.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
My fatigue significantly interferes with my daily life and is severe.
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I am between 18 and 65 years old.
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I can swallow pills without any issues.
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Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ screening, baseline, weeks 1, 2, 3, 4, 6 and 8
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~screening, baseline, weeks 1, 2, 3, 4, 6 and 8
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Fatigue Symptom Inventory (FSI)
Secondary study objectives
ADHD Quality of Life Scale (ADHDQOL)
ADHD Rating Scale (ADHD-RS)
Behavior Rating Inventory of Executive Functioning- Adult (BRIEF-A)
+4 moreAwards & Highlights
Drug Has Already Been Approved
The FDA has already approved this drug, and is just seeking more data.
Pivotal Trial
The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: Dyanavel XR (Active Agent)Active Control1 Intervention
Dyanavel 5, 10, 15 or 20 mg once daily in the morning
Group II: PlaceboPlacebo Group1 Intervention
Matching placebo 5, 10, 15 or 20 mg once daily in the morning
Find a Location
Closest Location:Rochester Center for Behavioral Medicine· Rochester Hills, MI· 845 miles
Who is running the clinical trial?
Rochester Center for Behavioral MedicineLead Sponsor
3 Previous Clinical Trials
96 Total Patients Enrolled
2 Trials studying Fatigue
70 Patients Enrolled for Fatigue
Joel Young, MDPrincipal InvestigatorMedical Director
2 Previous Clinical Trials
839 Total Patients Enrolled
1 Trials studying Fatigue
44 Patients Enrolled for Fatigue