SPN-812 for ADHD

Recruiting at 59 trial locations

Overseen By Ann Childress, MD

Age: < 18

Sex: Any

Trial Phase: Phase 4

Sponsor: Supernus Pharmaceuticals, Inc.

Must not be taking: CYP1A2 substrates

Disqualifiers: Major psychiatric, neurological disorders, 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: Unknown

Duration: 6 weeks

286 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a treatment called SPN-812 (also known as Viloxazine or Qelbree) to evaluate its effectiveness and safety for young children with ADHD. ADHD affects focus and behavior, often making it difficult for children to sit still or pay attention. The trial includes two groups: one receives the actual medication, while the other receives a placebo (a harmless pill with no active ingredients) for comparison. Children aged 4 to 5 years, diagnosed with ADHD, and experiencing symptoms that impact their daily activities might be suitable for this trial. As a Phase 4 trial, this research involves an FDA-approved treatment, aiming to understand its benefits for more patients.

Will I have to stop taking my current medications?

If you are currently taking a stimulant ADHD medication, you will need to stop it at least 1 week before the study begins. Also, you cannot use certain medications like theophylline or melatonin during the study.

What is the safety track record for SPN-812?

Research has shown that SPN-812, also known as viloxazine extended release, has undergone safety testing in several studies. One study found SPN-812 to be well tolerated over time, with no new safety issues. When used as directed, side effects were minimal. Another study supported these findings, demonstrating that SPN-812 is safe and effective for treating ADHD, with few side effects. However, some reports mention possible risks related to mood and behavior changes. Overall, current data indicates that SPN-812 has a strong safety record. ^{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 traditional treatments like stimulants (e.g., Adderall and Ritalin). Unlike these standard options, which primarily increase dopamine levels, SPN-812 is a non-stimulant that works by enhancing norepinephrine signaling in the brain. This mechanism could mean fewer side effects associated with stimulants, such as sleep issues and appetite loss. Additionally, SPN-812 aims to provide consistent symptom relief throughout the day, offering a more stable option for managing ADHD.

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

Research has shown that SPN-812, also known as viloxazine extended release, effectively treats ADHD in children and teens. In this trial, participants will receive either SPN-812 or a placebo. Studies found that those taking SPN-812 showed significant improvements in their ADHD symptoms. For instance, they scored lower on tests measuring ADHD symptoms and their impact on daily life. Early improvements after just two weeks of medication often predicted better results by week six. Using SPN-812 over a longer period has also linked to continued improvement in ADHD symptoms. Overall, SPN-812 has been well-tolerated and effective in managing ADHD. ^{1 6 7 8 9}

Who Is on the Research Team?

Jonathan Rubin, MD, MBA

Principal Investigator

Supernus Pharmaceuticals, Inc.

Are You a Good Fit for This Trial?

This trial is for medically healthy boys and girls aged between 4 years and 5 years 9 months with ADHD, as per DSM-IV-TR criteria. They must have a certain severity of symptoms, be in structured group activities like preschool, and not currently undergoing behavioral interventions for ADHD.

Inclusion Criteria

Has an ADHD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (females) at Screening and at Baseline (Day 1)

Has a CGI-S score of ≥ 4 (moderate or worse) at Screening and at Baseline (Day 1)

Is not currently receiving a behavioral intervention for ADHD at the time of screening nor plans to receiving a behavioral intervention for ADHD throughout their study (if subject is receiving a behavioral interventions for another psychiatric disorder or disorders, their eligibility will be evaluated on a case-by-case basis)

Exclusion Criteria

My BMI is above the 95th percentile for my age and gender.

Has a current diagnosis of a major psychiatric disorder

Has global development delay or intellectual disability by medical history

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

up to 4 weeks

Treatment

Participants receive SPN-812 or placebo for 6 weeks

6 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

2 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Placebo
• SPN-812

Trial Overview The study tests the effectiveness and safety of SPN-812 (viloxazine extended release) compared to a placebo in managing ADHD symptoms in preschool-age children. The goal is to see if this medication can help improve their attention and behavior.

How Is the Trial Designed?

Group I: SPN-812 Experimental Treatment 1 Intervention

SPN-812, qd

Group II: Placebo Placebo Group 1 Intervention

Placebo, qd

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+

Published Research Related to This Trial

Extended-release viloxazine (viloxazine ER) has been shown to significantly improve ADHD symptoms in school-age children and adolescents, with effective doses of 100 mg/d and 200 mg/d for children, and 200 mg/d and 400 mg/d for adolescents, compared to placebo.

As a nonstimulant medication, viloxazine ER offers a faster onset of action (1-2 weeks) than atomoxetine (4 weeks) and is suitable for patients who do not respond to or cannot tolerate stimulant medications, although it carries a boxed warning for suicidal ideation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Extended-Release Viloxazine for the Treatment of Attention-Deficit Hyperactivity Disorder in School-Age Children and Adolescents. Raible, H., D'Souza, MS.[2023]

In a study involving 22 healthy adults, SPN-812 (viloxazine) was found to have a modest increase in exposure when coadministered with the CYP2D6 inhibitor paroxetine, indicating that the two drugs can be safely used together without significant risk of adverse effects.

All adverse events reported during the trial were mild, suggesting that SPN-812 is well-tolerated even when taken with other medications that affect its metabolism.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Impact of Paroxetine, a Strong CYP2D6 Inhibitor, on SPN-812 (Viloxazine Extended-Release) Pharmacokinetics in Healthy Adults. Wang, Z., Kosheleff, AR., Adeojo, LW., et al.[2022]

In a Phase III study involving 313 children aged 6-11 with ADHD, SPN-812 (viloxazine extended-release) at doses of 200 mg and 400 mg once daily significantly improved ADHD symptoms compared to placebo, as measured by the ADHD Rating Scale (RS)-5 Total score.

The treatment was generally well tolerated, with less than 5% of participants discontinuing due to adverse events, indicating a favorable safety profile for SPN-812.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Once-Daily SPN-812 200 and 400 mg in the treatment of ADHD in School-aged Children: A Phase III Randomized, Controlled Trial. Nasser, A., Liranso, T., Adewole, T., et al.[2021]

In a 6-week randomized, double-blind, placebo-controlled trial involving 477 children aged 6-11, SPN-812 (viloxazine extended-release) significantly reduced ADHD symptoms, with improvements seen as early as week 1 and maintained through the end of the study.

SPN-812 was well tolerated, with a low discontinuation rate due to adverse events (less than 5%), and common side effects included somnolence, decreased appetite, and headache.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase III, Randomized, Placebo-controlled Trial to Assess the Efficacy and Safety of Once-daily SPN-812 (Viloxazine Extended-release) in the Treatment of Attention-deficit/Hyperactivity Disorder in School-age Children. Nasser, A., Liranso, T., Adewole, T., et al.[2021]

In an 8-week study involving 222 children aged 6 to 12, SPN-812 (extended-release viloxazine) significantly improved ADHD symptoms compared to placebo, particularly at doses of 200 mg, 300 mg, and 400 mg, with effect sizes ranging from 0.547 to 0.623.

The treatment was generally well tolerated, with common side effects including somnolence, headache, and decreased appetite, indicating a favorable safety profile as further investigations continue in Phase III trials.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase II Double-Blind, Placebo-Controlled, Efficacy and Safety Study of SPN-812 (Extended-Release Viloxazine) in Children With ADHD. Johnson, JK., Liranso, T., Saylor, K., et al.[2020]

In a trial involving 36 healthy adults, the combination of viloxazine extended-release (ER) and methylphenidate did not alter the pharmacokinetics of either drug, indicating that they can be safely coadministered without affecting their absorption or effectiveness.

The combination treatment was well tolerated, with all reported adverse events being mild, suggesting a favorable safety profile for using viloxazine ER alongside methylphenidate.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Coadministered Viloxazine Extended-Release (SPN-812) and Methylphenidate in Healthy Adults. Faison, SL., Fry, N., Adewole, T., et al.[2022]

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. 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 ( ...

3. 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.

4. link.springer.com link.springer.com/article/10.1007/s40263-025-01209-0

Results of a Long-Term, Phase 3, Open-Label Extension Trial Continued improvement of ADHD symptoms was observed and appeared sustained with long-term viloxazine ER treatment. The results of this large- ...

5. 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 ...

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

An Open-Label Extension Study Assessing the Long-Term ... Conclusions: Long-term viloxazine ER use was well tolerated, with no new long-term safety findings. Improvements in ADHD symptoms and associated ...

8. 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: ...

9. 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.