SPN-812 ER for ADHD

Not currently recruiting at 15 trial locations

Age: < 65

Sex: Any

Trial Phase: Phase 3

Sponsor: Supernus Pharmaceuticals, Inc.

Must be taking: SPN-812

Disqualifiers: Systemic disease, Major psychiatric, Neurological, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 6

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the long-term safety and effectiveness of SPN-812 ER, a treatment for ADHD in children. It is an open-label study, meaning all participants know they are receiving the actual treatment. The trial focuses on children and teens who have completed a previous study with SPN-812, are in good health, and meet specific weight criteria. Children who have finished a prior SPN-812 study and have no major health issues might be suitable for this trial. As a Phase 3 trial, it represents the final step before FDA approval, providing an opportunity to contribute to the availability of a new ADHD treatment.

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the study team or your doctor.

Is there any evidence suggesting that SPN-812 ER is likely to be safe for humans?

Research has shown that SPN-812 ER, a medication for ADHD, has been well-tolerated in past studies. The FDA approved it for children and, in 2022, also for adults, based on evidence of its effectiveness and safety in various studies. One study noted that SPN-812 significantly reduced ADHD symptoms and was generally well-tolerated. However, another study advised that safety concerns should still be considered, despite its strong effectiveness.

While many have tolerated SPN-812 well, awareness of any reported side effects or adverse events remains important. Prospective trial participants might find this information helpful in understanding the treatment's safety history. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for ADHD?

Researchers are excited about SPN-812 ER for ADHD because it offers a novel approach to managing symptoms compared to current treatments like stimulant medications. Unlike standard stimulant options, which often work by increasing dopamine and norepinephrine activity, SPN-812 ER is a non-stimulant that targets the norepinephrine system differently, potentially reducing common side effects such as sleep issues and appetite loss. This treatment also provides the convenience of once-daily dosing, which could improve adherence, especially in pediatric patients. Overall, SPN-812 ER promises a fresh alternative with a potentially better side effect profile for those who struggle with or prefer not to use stimulants.

What evidence suggests that SPN-812 ER might be an effective treatment for ADHD?

Research has shown that SPN-812 ER, also known as viloxazine ER, improves ADHD symptoms in children. One study found that children taking SPN-812 experienced a noticeable reduction in ADHD symptoms compared to those taking a placebo, which contains no active medicine. Additionally, long-term results suggest these improvements persist over time. The treatment was well-tolerated, indicating it is generally safe for children. ^{1 3 6 7 8}

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 children with ADHD who weigh at least 20 kg (6-11 years old) or 35 kg (12+ years), have completed a prior SPN-812 study, and are in good health. Girls able to have babies must not be pregnant, breastfeeding, and if sexually active, use reliable birth control.

Inclusion Criteria

I weigh at least 20 kg if I'm 6-11 years old, or at least 35 kg if I'm 12 or older.

I am using effective birth control or am not sexually active.

Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR); written Informed Assent/Consent obtained from the subject if appropriate.

Exclusion Criteria

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

Pregnancy, breastfeeding or refusal to practice contraception during the study for FOCP

You are currently using drugs or drinking alcohol.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Optimization

Participants' dosages are optimized for individual needs

6 months

Visits every 3 months

Maintenance

Participants continue treatment with SPN-812 to assess long-term safety and efficacy

Up to 72 months for Cohort A, up to 24 months for Cohort B

Visits every 3 months

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• SPN-812 ER

Trial Overview

The trial tests the long-term safety and effectiveness of an extended-release medication called SPN-812 for treating pediatric ADHD. It's an open-label study where all participants know they're receiving the actual drug.

How Is the Trial Designed?

Group I: Open-Label Treatment Experimental Treatment 1 Intervention

Cohort 'A': Pediatric subjects 6-17 years of age who completed a Phase 2 (Study 812P202) or one of four Phase 3 trials (Study 812P301-P304). Cohort 'B': Pediatric subjects 4-5 years of age who completed a Phase 4 trial.

Who Is Running the Clinical Trial?

Supernus Pharmaceuticals, Inc.

Lead Sponsor

Trials

49

Recruited

14,000+

Published Research Related to This Trial

In a Phase 3 trial involving 297 adolescents with ADHD, the 400 mg/day dose of SPN-812 showed a statistically significant improvement in ADHD symptoms compared to placebo, while the 600 mg/day dose did not demonstrate superiority, likely due to a high placebo response.

SPN-812 was well tolerated across both doses, with a low discontinuation rate of less than 5% due to adverse events, indicating a favorable safety profile.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Phase 3 Placebo-Controlled Trial of Once-Daily 400-mg and 600-mg SPN-812 (Viloxazine Extended-Release) in Adolescents with ADHD. Nasser, A., Liranso, T., Adewole, T., 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 study involving 1397 pediatric patients with ADHD, early response to treatment with SPN-812 was found to be a strong predictor of long-term efficacy, with a 75% positive predictive power after just two weeks.

The most significant indicators of treatment success were changes in ADHD Rating Scale-5 scores and Clinical Global Impressions-Improvement scores, highlighting the importance of monitoring early treatment responses.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early response to SPN-812 (viloxazine extended-release) can predict efficacy outcome in pediatric subjects with ADHD: a machine learning post-hoc analysis of four randomized clinical trials. Faraone, SV., Gomeni, R., Hull, JT., et al.[2021]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC6939319/

A Phase II Double-Blind, Placebo-Controlled, Efficacy and ...

Conclusion: SPN-812 significantly reduced the severity of ADHD symptoms and was well tolerated. The efficacy and safety of SPN-812 are being investigated in ...

2.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC9328182/

A Phase III, Randomized, Double-Blind, Placebo-Controlled ...

Treatment with viloxazine ER resulted in a statistically significant improvement in primary and key secondary endpoints, indicating improvements ...

3.

clinicaltrials.gov

clinicaltrials.gov/study/NCT03247530

Study Details | NCT03247530 | Evaluation of SPN-812 ...

This is a multicenter, randomized, double-blind, placebo-controlled, 3-arm, parallel-group study, to assess the efficacy and safety of SPN-812 as monotherapy ...

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.

sciencedirect.com

sciencedirect.com/science/article/pii/S0165178122005133

Machine learning Post Hoc analysis of a phase 3 clinical trial

Response was defined as ≥50% reduction from baseline in the Adult ADHD Investigator Symptoms Rating Scale (AISRS) Total score at Week 6. The adult study sample ...

6.

accessdata.fda.gov

accessdata.fda.gov/drugsatfda_docs/nda/2021/211964Orig1s000IntegratedR.pdf

211964Orig1s000 INTEGRATED REVIEW - accessdata.fda.gov

On November 8, 2019, the Applicant submitted a 505(b)(1) new drug application (NDA) for viloxazine ER for the treatment of ADHD in children and ...

7.

link.springer.com

link.springer.com/article/10.1007/s40263-024-01120-0

An Open-Label Extension Study Assessing the Long-Term ...

FDA approval was expanded to include adults with ADHD in 2022 on the basis of demonstrated efficacy and safety in a phase III, double-blind, ...

8.

pmc.ncbi.nlm.nih.gov

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

Efficacy and Safety of SPN-812 (Extended-Release Viloxazine ...

At present, SPN-812 (100, 200, and 400 mg/d) is superior to the corresponding control in efficacy measures. However, the safety problem cannot be ignored.