SPN-812 for ADHD

Recruiting at 56 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

Trial Summary

What is the purpose of this trial?

This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.

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 data supports the effectiveness of the drug SPN-812 for treating ADHD?

Research shows that SPN-812 (viloxazine extended-release) significantly reduces ADHD symptoms in children, with improvements in ADHD rating scores compared to a placebo. It was well tolerated, with common side effects like sleepiness and headache. ^{1 2 3 4 5}

Is SPN-812 (Viloxazine) safe for humans?

SPN-812 (Viloxazine) has been studied in children and adolescents with ADHD and was generally well tolerated, with common side effects including sleepiness, headache, and decreased appetite. Safety assessments in studies included monitoring for serious issues like heart problems and suicidal thoughts, and the treatment was found to be safe in these trials. ^{1 2 3 4 5}

How is the drug SPN-812 different from other ADHD treatments?

SPN-812 (viloxazine extended-release) is unique because it is a non-stimulant that works by affecting serotonin receptors and the norepinephrine transporter, unlike many ADHD medications that are stimulants. It is taken once daily, which can be more convenient for children and adolescents. ^{1 2 3 4 6}

Research Team

Jonathan Rubin, MD, MBA

Principal Investigator

Supernus Pharmaceuticals, Inc.

Eligibility Criteria

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

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)

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)

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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 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 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 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]

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]

References

1. United States 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. [2021]

2. United States 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. [2020]

3. United States 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. [2021]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Pharmacokinetics of Coadministered Viloxazine Extended-Release (SPN-812) and Methylphenidate in Healthy Adults. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Extended-Release Viloxazine for the Treatment of Attention-Deficit Hyperactivity Disorder in School-Age Children and Adolescents. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Impact of Paroxetine, a Strong CYP2D6 Inhibitor, on SPN-812 (Viloxazine Extended-Release) Pharmacokinetics in Healthy Adults. [2022]