NCT04781140

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

A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of SPN-812 in Preschool-Age Children (4 to 5 Years Old) With Attention-Deficit/Hyperactivity Disorder (ADHD)

• Status: Recruiting
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 286 (estimated)
• Sponsor: Supernus Pharmaceuticals, Inc. · Industry
• Sex: All
• Age: 48 Months – 69 Months
• Healthy volunteers: Not accepted

Summary

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

Detailed description

This is a randomized, double-blind, placebo-controlled, multicenter, 2-arm (1:1), parallel-group, efficacy and safety/tolerability fixed-dose study of SPN-812 in preschool-age children (4 to 5 years old) with ADHD. Participants will be screened for eligibility for up to 4 weeks. Eligible participants will be treated with study medication for 6 weeks. The total duration of the study is up to 10 weeks.

Conditions

• Attention-Deficit/Hyperactivity Disorder

Interventions

Type	Name	Description
DRUG	100mg SPN-812	100mg SPN-812 will be administered once daily and compared to Placebo
DRUG	Placebo	Placebo will be administered once daily

Timeline

• Start date: 2024-03-19
• Primary completion: 2026-06-01
• Completion: 2026-06-01
• First posted: 2021-03-04
• Last updated: 2026-02-18

Locations

47 sites across 1 country: United States

Regulatory

• FDA-regulated drug study