Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
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Phase
Phase 4
Status
Recruiting
Study type
Interventional
Design
Randomized · Quadruple · Treatment
Enrollment
286estimated
Sites
47
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2024-03-19 | actual | When the study began enrolling |
| Primary completion | Jun 2026 | estimated | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | Jun 2026 | estimated | The whole study's end, after follow-up |
| First posted | 2021-03-04 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2026-02-18 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Condition
- Attention-Deficit/Hyperactivity Disorder
Interventions
- Drug: 100mg SPN-812 — also filed as SPN-812
- Drug: Placebo
Primary outcome
what the primary-completion date above is the date OFChange 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)
measured Baseline and Week 6
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