Dyanavel XR for ADHD and Fatigue

Overseen By Jaime Saal, MA

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Rochester Center for Behavioral Medicine

Must not be taking: CNS stimulants, MAOIs

Disqualifiers: Substance abuse, Unstable psychiatric, Heart disease, others

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 1 Jurisdiction This treatment is already approved in other countries

Compensation: Varies

Number of Visits: 3

Duration: 10 weeks

50 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial investigates whether Dyanavel XR, a medication typically prescribed for ADHD, can also reduce fatigue in adults with both ADHD and significant tiredness. Participants will receive either Dyanavel XR or a placebo (a non-active pill) to determine if there is a noticeable difference in fatigue levels. The study seeks adults diagnosed with ADHD who experience significant fatigue impacting daily life. As a Phase 4 trial, this research aims to understand how this FDA-approved and effective treatment can benefit more patients.

Will I have to stop taking my current medications?

The trial requires that some medications, especially stimulant medications like methylphenidate or amphetamine-based drugs, be stopped before starting the study. The primary investigator will review your current medications to decide if they might interfere with the study drug.

What is the safety track record for Dyanavel XR?

Research has shown that Dyanavel XR, a medication for ADHD, is generally safe but carries some risks. Studies have found it can cause side effects such as a faster heartbeat, higher blood pressure, and nervousness. In rare cases, serious heart issues like sudden death, stroke, and heart attack have been reported in adults using similar stimulant medications.

Dyanavel XR also carries a high risk of misuse and addiction due to its stimulant nature. This is important to consider when thinking about joining a trial. However, Dyanavel XR has FDA approval for treating ADHD, indicating its safety has been tested in other settings. Always discuss any concerns with a healthcare provider before joining a clinical trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Most treatments for ADHD and fatigue involve stimulants or non-stimulant medications like methylphenidate, amphetamine salts, or atomoxetine. Dyanavel XR is unique because it offers a once-daily extended-release liquid formulation, making it easier to adjust dosages and potentially improving adherence, especially in individuals who have difficulty swallowing pills. Researchers are excited about Dyanavel XR as it combines amphetamine with a delivery system that allows for smoother and more sustained release of the medication, which may enhance focus and reduce fatigue throughout the day with fewer peaks and troughs in symptom control.

What evidence suggests that Dyanavel XR might be an effective treatment for fatigue in adults with ADHD?

Research has shown that Dyanavel XR, which participants in this trial may receive, helps alleviate ADHD symptoms. Studies have found it improves focus and reduces hyperactivity more effectively than a placebo. For ADHD, Dyanavel XR acts quickly and has long-lasting effects. While the trial tests its potential to reduce fatigue in people with ADHD, its known benefits suggest it might help with fatigue as well. However, no published data specifically proves it reduces fatigue yet. ^{4 6 7 8 9}

Who Is on the Research Team?

Joel Young, MD

Principal Investigator

Medical Director

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

My fatigue significantly interferes with my daily life and is severe.

I can sign and understand the consent form for this study.

I understand and can follow the study's requirements and medication instructions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

1 visit (in-person)

Treatment

Participants receive Dyanavel XR or placebo with flexible titration dosing for 10 weeks

10 weeks

Weekly visits (in-person or virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• Dyanavel XR

Trial Overview 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.

How Is the Trial Designed?

Group I: Dyanavel XR (Active Agent) Active Control 1 Intervention

Dyanavel 5, 10, 15 or 20 mg once daily in the morning

Group II: Placebo Placebo Group 1 Intervention

Matching placebo 5, 10, 15 or 20 mg once daily in the morning

Dyanavel XR is already approved in United States for the following indications:

Approved in United States as Dyanavel XR for:

• Attention Deficit Hyperactivity Disorder (ADHD)

Who Is Running the Clinical Trial?

Rochester Center for Behavioral Medicine

Lead Sponsor

Trials

4

Recruited

150+

Published Research Related to This Trial

In a 2-year open-label study involving participants aged 6-17 with ADHD, extended-release guanfacine (GXR) demonstrated long-term safety and efficacy, with most adverse events being mild to moderate.

Significant improvements in ADHD symptoms were observed as early as the first month and continued throughout the 24-month treatment period, supporting GXR as a viable monotherapy for ADHD.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Long-term safety and efficacy of guanfacine extended release in children and adolescents with attention-deficit/hyperactivity disorder. Sallee, FR., Lyne, A., Wigal, T., et al.[2013]

In a study involving 22 adults with ADHD, both modafinil and dextroamphetamine significantly improved ADHD symptoms compared to placebo, with modafinil showing promise as an alternative treatment.

Both medications were well tolerated, suggesting that modafinil could be a viable option for adults seeking treatment for ADHD without the side effects commonly associated with traditional stimulants.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of modafinil compared to dextroamphetamine for the treatment of attention deficit hyperactivity disorder in adults. Taylor, FB., Russo, J.[2018]

A review of treatments for adult ADHD found that approved long-acting medications, including stimulants and the nonstimulant atomoxetine, are effective in improving symptoms and generally well tolerated, based on a synthesis of studies from 2002 to 2011.

Different long-acting medications have unique formulations that affect their release and potential for abuse, but all have similar efficacy and safety profiles, making them viable options for managing ADHD in adults.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Treating attention-deficit/hyperactivity disorder in adults: focus on once-daily medications. Weisler, RH., Childress, AC.[2021]

Modafinil has been shown to significantly improve symptoms of ADHD and cognitive function in patients, based on a review of 4 randomized clinical trials.

The medication has a favorable safety profile, with common side effects like insomnia and headache occurring in about 20% of patients, but its long-term efficacy remains uncertain and requires further research.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Use of modafinil for the treatment of attention deficit/hyperactivity disorder. Lindsay, SE., Gudelsky, GA., Heaton, PC.[2018]

Dyanavel XR (AMPH EROS) is an extended-release oral suspension designed for patients with ADHD who have difficulty swallowing pills, providing a flexible dosing option that can be adjusted based on individual needs.

Clinical trials have shown that AMPH EROS is effective in managing ADHD symptoms, and it offers a convenient alternative to traditional amphetamine formulations, although its higher cost may limit accessibility for some patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Amphetamine extended-release oral suspension for attention-deficit/hyperactivity disorder. Childress, AC., Chow, H.[2019]

Extended-release guanfacine (Intuniv) significantly improves symptoms of inattention and hyperactivity-impulsivity in children and adolescents with ADHD, with effective doses ranging from 1 to 4 mg/day compared to placebo.

While GXR does not cause significant ECG changes, it can lead to mild heart rate slowing and lower blood pressure, necessitating monitoring of vital signs, especially in children with a history of cardiovascular issues.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Guanfacine extended release in the treatment of attention deficit hyperactivity disorder in children and adolescents. Connor, DF., Rubin, J.[2017]

Guanfacine extended-release (GXR) has been shown to be an effective treatment for ADHD in children aged 6-12, outperforming placebo in all randomized controlled trials reviewed.

However, GXR did not demonstrate efficacy in adolescents, and while adverse effects were generally mild to moderate, there were high rates of early discontinuation in long-term studies.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Focus on Guanfacine Extended-release: A Review of its Use in Child and Adolescent Psychiatry. Elbe, D., Reddy, D.[2021]

In a 2-week placebo-controlled trial involving 23 men with HIV, 73% of those treated with dextroamphetamine reported significant improvements in mood and energy, compared to only 25% in the placebo group, indicating its efficacy as a treatment for depression and fatigue.

The study found no evidence of tolerance, abuse, or dependence on dextroamphetamine, suggesting it is a safe option for patients with HIV experiencing depressive symptoms and fatigue.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of dextroamphetamine on depression and fatigue in men with HIV: a double-blind, placebo-controlled trial. Wagner, GJ., Rabkin, R.[2019]

Adderall XR is a long-acting psychostimulant approved for treating ADHD in both children and adults, with a 12-hour duration of action and demonstrated superior efficacy compared to the nonstimulant atomoxetine.

The largest effectiveness trial for ADHD therapies confirmed that Adderall XR significantly improves quality of life in children and shows proven safety and efficacy in adults, with potential benefits for treating comorbid conditions like oppositional defiant disorder.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Adderall XR: long acting stimulant for single daily dosing. Sallee, FR., Smirnoff, AV.[2019]

In a 5-week study involving 130 adults with ADHD, amphetamine extended-release tablets (AMPH ER TAB) significantly improved attention performance compared to placebo, with higher mean scores on the Permanent Product Measure of Performance (PERMP) test at multiple time points post-dose.

The safety profile of AMPH ER TAB was favorable, with common side effects like decreased appetite and insomnia being mostly mild to moderate, and no serious adverse events reported during the trial.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Randomized, Double-Blind, Placebo-Controlled, Fixed-Dose Study to Evaluate the Efficacy and Safety of Amphetamine Extended-Release Tablets in Adults With Attention-Deficit/Hyperactivity Disorder. Cutler, AJ., Childress, AC., Pardo, A., et al.[2022]

The extended-release formulation of mixed amphetamine salts (MAS XR) effectively improves ADHD symptoms in children, adolescents, and adults, as demonstrated in both short- and long-term studies.

MAS XR is generally well tolerated, and a specific study indicates it can be safely used in adults with ADHD who also have primary essential hypertension, although its safety in patients with other cardiovascular conditions still needs further evaluation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stimulant therapy in the management of ADHD: mixed amphetamine salts (extended release). Faraone, SV.[2019]

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06248229

A Trial of Dyanavel XR in Treating Co-occurring Fatigue ... The goal of this clinical trial is to study the impact of Dyanavel on co-occuring fatigue in adults with Attention Deficit/Hyperactivity Disorder.

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39754122/

Extended-release amphetamine (Dyanavel XR) is ... Dyanavel XR was significantly associated with reduced IR supplementation at 90 days compared to the pooled group of patients taking other ER medications.

3. dyanavelxr.com dyanavelxr.com/study-results/

Study Results | Dyanavel® XR (amphetamine) | Tris Pharma DYANAVEL XR was shown to improve ADHD symptoms compared to placebo when measured with a standardized performance test, the PERMP.

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5994670/

Efficacy and Safety of Amphetamine Extended-Release ... Conclusion: AMPH EROS was effective in reducing symptoms of ADHD and had a rapid onset and extended duration of effect. Reported AEs were consistent with those ...

5. bmcpsychiatry.biomedcentral.com bmcpsychiatry.biomedcentral.com/articles/10.1186/s12888-024-06446-z

Extended-release amphetamine (Dyanavel XR) is associated ... The current research shows that Dyanavel XR is uniquely associated with reductions in the tendency to supplement daily ER treatment with IR ...

6. trisadhdhcp.com trisadhdhcp.com/dyanavel-xr-tablet/safety-data/

Safety Data | DYANAVEL® XR (amphetamine) Tablet DYANAVEL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of ...

7. dyanavelxrhcp.com dyanavelxrhcp.com/dyanavel-xr-liquid/safety-data/

Safety Data | DYANAVEL® XR (amphetamine) | Tris Pharma ... DYANAVEL XR has a high potential for abuse and misuse, which can lead to the development of a substance use disorder, including addiction. Misuse and abuse of ...

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/label/2021/210526s000lbl.pdf

Dyanavel XR (amphetamine) - accessdata.fda.gov Sudden death, stroke and myocardial infarction have been reported in adults with CNS stimulant treatment at recommended doses. Sudden death has been reported in ...

9. fda.gov fda.gov/media/181801/download

Dynavel Pediatric Postmarketing Safety Review The safety and effectiveness have been established in pediatric patients with ADHD ages 6 to 17 years [see. Adverse Reactions (6.1), Clinical ...