SPN-812 for ADHD

Not currently recruiting at 1 trial location

Overseen By Leslie Brijbasi

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: Supernus Pharmaceuticals, Inc.

Must not be taking: Non-stimulants, Qelbree

Disqualifiers: Substance use disorder, Neurological disorder, Schizophrenia, Bipolar, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

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: 5

Duration: 14 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness and safety of a medication called SPN-812 (also known as Viloxazine or Qelbree) for adults with ADHD and mood symptoms. The goal is to evaluate how well this treatment works and its safety for individuals with these conditions. Participants will take SPN-812 once daily for up to 14 weeks. This trial may suit adults diagnosed with ADHD who experience mood symptoms like anxiety or depression. Participants must have access to a smartphone and be willing to attend online appointments during the trial. As a Phase 4 trial, this research aims to understand how this already FDA-approved and effective treatment benefits more patients.

Do I have to stop taking my current medications for the trial?

You may need to stop taking certain medications for this trial. If you are currently taking Qelbree or other non-stimulant ADHD medications like atomoxetine, clonidine, or guanfacine, you cannot participate. Stimulant medications for ADHD and most medications for mood symptoms are allowed.

What is the safety track record for SPN-812?

A previous study approved SPN-812 for treating ADHD in children and teens, indicating a good safety record for younger patients. Research has shown that SPN-812 is generally safe for adults as well. Long-term studies found that adults tolerated SPN-812 well, with no new safety issues over time.

SPN-812 also proved effective and safe, with few side effects when used as directed. However, some research mentions possible risks related to mood and behavior. These effects might occur but are not certain. Overall, current evidence suggests that SPN-812 is a safe option for many people with ADHD. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Researchers are excited about SPN-812 for ADHD because it offers a unique approach compared to typical stimulant-based treatments like Adderall and Ritalin. Unlike these standard options, which primarily target dopamine pathways, SPN-812 works by modulating norepinephrine, a different neurotransmitter involved in attention and behavior regulation. This new mechanism of action could mean fewer side effects related to stimulants, such as anxiety or sleep disturbances. Additionally, SPN-812 is administered once daily, which can simplify treatment routines for patients.

What is the effectiveness track record for SPN-812 in treating ADHD?

Research has shown that SPN-812, the treatment under study in this trial, helps alleviate ADHD symptoms. In earlier studies, participants taking SPN-812 demonstrated noticeable improvements in attention and hyperactivity. Many adults taking 400 mg or more experienced positive results over time. Additionally, SPN-812 was generally safe, with most participants not experiencing serious side effects. Overall, these findings support SPN-812's effectiveness in managing ADHD symptoms. ^{1 3 6 7 8}

Are You a Good Fit for This Trial?

Adults over 18 with ADHD and mood symptoms, who can sign consent and use the study app for telemedicine appointments. Women must not be pregnant or nursing and agree to birth control if of childbearing potential; men should agree to contraception too. Excludes recent substance abusers, those on certain medications, or with severe mental health issues.

Inclusion Criteria

Has a CGI-S score ≥3 at Screening

Has an AISRS Total score ≥24 at Screening

I am willing and able to give my consent electronically.

Exclusion Criteria

I am pregnant, nursing, or not using birth control while sexually active with a male partner.

I have had a serious head injury or neurological condition that may affect my brain function.

Has any history of schizophrenia, schizoaffective disorder, or bipolar disorder, or has any other psychiatric disorders in the investigator's clinical judgement would interfere with their ability to participate in the study

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

Up to 4 weeks

Up to 2 visits (virtual)

Treatment

Participants receive SPN-812 with flexible dosing for up to 14 weeks

14 weeks

3 visits (virtual)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SPN-812

Trial Overview The trial is testing SPN-812 (Qelbree®) in adults with ADHD and mood symptoms. It's an open-label study where everyone gets the drug at flexible doses to see how effective and safe it is when participants manage their own treatment using a mobile app.

How Is the Trial Designed?

Group I: Open-Label Treatment Experimental Treatment 1 Intervention

SPN-812 (200mg to 600mg once daily) for up to 14 weeks

SPN-812 is already approved in United States for the following indications:

Approved in United States as Qelbree for:

• Attention Deficit Hyperactivity Disorder (ADHD) in adults and pediatric patients 6 years and older

Who Is Running the Clinical Trial?

Supernus Pharmaceuticals, Inc.

Lead Sponsor

Trials

49

Recruited

14,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10742293/

Efficacy and Safety of SPN-812 (Extended-Release Viloxazine ... In our study, patients treated with SPN-812 (100 mg/d, 200 mg/d, and 400 mg/d) had significantly lower Conners 3-PS and WFIRS-P scores than ...

2. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/39373844/

An Open-Label Extension Study Assessing the Long-Term ... In total, 73% percent of adult participants in this long-term study used viloxazine ER doses of 400 mg or more during maintenance treatment.

3. clinicaltrials.gov clinicaltrials.gov/study/NCT03247530

Study Details | NCT03247530 | Evaluation of SPN-812 ... The Primary Endpoint was the change from baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 5th Edition (ADHD-RS-5) Total score at Week 6 ( ...

4. jamanetwork.com jamanetwork.com/journals/jamanetworkopen/fullarticle/2826361

Response Trajectories and Temporal Trends of Viloxazine ... In this study, viloxazine was well-tolerated and associated with improvements in ADHD symptoms, and a moderate dose (200-400 mg or 6-8 mg/kg) appeared to ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S0165178120333254

Early response to SPN-812 (viloxazine extended-release) ... Early response after two weeks of treatment with once-daily SPN-812 in pediatric patients with ADHD can predict efficacy outcome at Week 6.

6. clinicaltrials.gov clinicaltrials.gov/study/NCT06185985?term=AREA%5BBasicSearch%5D(AREA%5BInterventionSearch%5D(VIVALAN)%20AND%20AREA%5BStudyType%5D(INTERVENTIONAL))&rank=4

Open-label Safety and Efficacy of SPN-812 (Viloxazine ... This is a Phase IV, open-label, flexible dose, decentralized clinical trial to evaluate the efficacy and safety of SPN-812 in adults with ADHD and mood ...

7. qelbree.com qelbree.com/adults/about-qelbree/adhd-treatment-with-qelbree

Non-Stimulant ADHD Treatment Results - Qelbree® Qelbree was proven to be a safe‡ and effective treatment for ADHD, with a low incidence of side effects in a clinical trial when taken as directed. Important: ...

8. sciencedirect.com sciencedirect.com/science/article/abs/pii/S0165032725006615

Analysis of risk signals for Viloxazine in the treatment ... Viloxazine has shown efficacy and tolerability but poses potential safety risks, particularly regarding mood, behavior, and sensory processing.