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)

Date Added
March 11th, 2026
PRO Number
Pro00146607
Researcher
Stephen Stripling

List of Studies

Keywords
ADD/ADHD, Children's Health
Summary

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 a DSM-IV-TR diagnosis of ADHD. Approximately 286 subjects will be randomized to either SPN-812 or matching placebo in a 1:1 ratio (143 subjects per arm). Following up to 4 weeks of screening, subjects will be treated with study medication (SM) for 6 weeks, then will either be enrolled in a separate OLE study or followed for an additional 1 week for safety. The total duration of the study is up to 10 weeks.

Institution
MUSC
Recruitment Contact
Sydney Horton
843.473.6616
syh206@musc.edu



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