Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
Phase 4
286
about 1.8 years
4–5.75
47 sites in AL, AR, CA +21
About this study
This trial is testing a treatment called SPN-812 in children aged 4 to 5 years old who have ADHD. The goal is to see if this treatment helps with their symptoms and whether it's safe for them.
Based on ClinicalTrials.gov records.
What participants do
- 1.Take 100mg SPN-812
- 2.Take Placebo
Participation effort
Estimated from trial records. Details can vary by site.
Logistics difficulty varies by site location and availability.
Trial highlights
Treatment details
Auto-extracted from trial records to preview treatments and outcomes.
Primary: Change from Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Total Score at End of Study (Week 6)
Secondary: Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Responder Rate (percentage of subjects with ≥ 50% Reduction in Change from Baseline) at End of Study (Week 6), Change from Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Hyperactivity/Impulsivity Subscale Score at End of Study (Week 6), Change from Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Inattention Subscale Score at End of Study (Week 6), Change from Baseline in the Clinical Global Impression of Severity (CGI-S) Score at End of Study (Week 6)
Psychiatry / Mental Health