What is SPN-812 studying for ADHD in children?

SPN-812 is being studied to evaluate its effects on ADHD symptoms in preschool-age children. This trial aims to assess how well the medication works and its safety in children aged 4 to 5 years. The study is sponsored by Supernus Pharmaceuticals, Inc.

Who may be eligible for this ADHD clinical trial?

Children aged between 4 years 0 months and 5 years 9 months with a confirmed diagnosis of ADHD may be eligible. Both boys and girls can participate. Important factors include symptom severity, current participation in group activities, and not recently starting new behavioral therapies. Please review eligibility criteria for more details.

Is there any cost to participate in this ADHD clinical trial?

Study-related care, including the study drug or procedure and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect their study visits and medication to be provided free during the trial.

Actively Recruiting

Phase 4

Age: 48Months - 69Months

All Genders

ID04781140

Phase 4 Study of SPN-812 Viloxazine Extended-Release for Treating ADHD in Children Ages 4 to 5 Years

Led by Supernus Pharmaceuticals, Inc. · Updated on 2026-02-18

286

Participants Needed

Research Sites

N/A

Total Duration

AI-Summary

What this Trial Is About

Researchers are evaluating the efficacy and safety of SPN-812 viloxazine extended release in children aged 4 to 5 years with Attention-DeficitHyperactivity Disorder ADHD. This phase 4 study is randomized, double-blind, placebo-controlled, and involves multiple centers. It aims to assess treatment effects and tolerability in this preschool-age group with ADHD symptoms confirmed by specific diagnostic criteria. Participants will be randomly assigned to receive either 100mg of SPN-812 or a placebo once daily for 6 weeks. The study includes a screening period of up to 4 weeks to determine eligibility. The total study duration for each participant is up to 10 weeks, during which the two groups will be compared to evaluate the impact of the medication versus placebo. During the study, children will be assessed using the Attention-DeficitHyperactivity Disorder Rating Scale, 4th Edition, Preschool Version ADHD-RS-IV-P and the Clinical Global Impression scales to measure symptom severity and change. Safety and tolerability will be monitored throughout. Parents or guardians will provide consent, and children will participate in structured activities to help evaluate their symptoms outside the home. Regular study visits will include clinical evaluations and monitoring over the 6-week treatment period.

CONDITIONS

Brief Title

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD

Who Can Participate

Age: 48Months - 69Months

All Genders

Eligibility Criteria

You may qualify if you...

Male or female aged 4 years 0 months to 5 years 9 months at screening and medically healthy
Parent or legal guardian able and willing to provide written informed consent
Primary diagnosis of ADHD by DSM-IV-TR criteria confirmed with K-SADS-PL
ADHD-RS-IV-P Total Score ≥ 28 (males) or ≥ 24 (females) at screening and baseline
Clinical Global Impression-Severity score ≥ 4 (moderate or worse) at screening and baseline
Adequate non-drug treatment or symptoms severe enough to need medication
Participating in structured group activity at least 2 days per week during study
No new behavioral therapy started within 30 days before screening, and no planned changes during study
If on ADHD medication, symptoms not well controlled and medication stopped at least 7 days before baseline
No conditions that could affect assessments or increase risk
Living with same parent(s) or under shared custody for at least 6 months prior to screening
Body weight at or above 5th percentile for age and sex at screening and baseline

You will not qualify if you...

Diagnosis of another primary psychiatric disorder or comorbid disorder likely to interfere with study
Major neurological disorder or history of seizures assessed case-by-case
Family history of Bipolar Disorder in first degree relative
Global developmental delay or intellectual disability
Significant systemic disease per investigator judgment
Body mass index above 95th percentile at screening or baseline
Blood pressure and pulse rate above 95th percentile for age and sex at screening or baseline
Clinically significant ECG findings at screening
Current or prior use of SPN-812 discontinued due to lack of effect or adverse reactions
Allergic reaction, hypersensitivity, or intolerance to viloxazine
Allergy to pudding or applesauce or inability to swallow intact capsule
Food allergy or dietary restrictions contraindicating study participation
Recent investigational drug use within 30 days or 5 half-lives before baseline
Positive urine drug test at screening (except allowed stimulant medication)
Use of prohibited medications including certain CYP1A2 substrates during screening or study
Any reason per investigator preventing participation
Suicidal ideation or behavior within 6 months or lifetime suicide attempt per C-SSRS at screening

Research Team

Joseph T Hull, PhD

Leslie Brijbasi

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Phase 4 Study of SPN-812 Viloxazine Extended-Release for Treating ADHD in Children Ages 4 to 5 Years

On this page

AI-Summary

What this Trial Is About

Brief Title

Who Can Participate

Eligibility Criteria

Research Team

Not the Right Trial for You?

On this page

Who Can Participate

Eligibility Criteria