Medical Information Only. Always consult your healthcare provider before enrolling in any clinical trial.
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
NCT04781140 · View on ClinicalTrials.gov ↗
Study 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.
Conditions Studied
Interventions
- DRUG Placebo
- DRUG 100mg SPN-812
Study Locations (20)
Florida
- Luna Research Center — Coral Gables
- Sarkis Clinical Trials — Gainesville
- Clinical Neuroscience Solutions, Inc. — Jacksonville
- Avantis Clinical Research LLC — Miami
- Hope Research Network, LLC. — Miami
- Medical Research Group of Central Florida — Orange City
- Clinical Neuroscience Solutions, Inc. — Orlando
- APG Research LLC — Orlando
- D&H Tamarac Research Center — Tamarac
- Pediatric Neurology and Epilepsy Specialists — Winter Park
Georgia
- Advanced Discovery Research LLC — Atlanta
- Clinical Integrative Research Center of Atlanta — Atlanta
- CenExcel iResearch, LLC — Decatur
- CenExel iResearch, LLC. — Savannah
California
- Advanced Research Center (ARC), Inc. — Anaheim
- Sun Valley Research Center — Imperial
- Alliance Research — Long Beach
Alabama
- The Center for Clinical Trials, Inc. — Saraland
Arkansas
- Preferred Research Partners, Inc. — Little Rock
Colorado
- IMMUNOe Research Centers — Centennial
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 286 participants |
| Start Date | 2024-03-19 |
| Est. Completion | 2026-06 |
| Phase | Phase 4 |
Interested in This Trial?
Always speak with your doctor before enrolling in a clinical trial.
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT04781140
The ClinicalTrials.gov registry entry for NCT04781140 describes a study currently listed as recruiting. It is categorized as Phase 4, which is the standard way researchers label where a study sits along the investigational pathway from early safety work through later efficacy and post-marketing evaluation. The registered enrollment target is 286 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Supernus Pharmaceuticals, which has 43 total studies on file at ClinicalTrials.gov, and sponsors are the parties responsible for study design, oversight, and regulatory filings.
The record links to 1 condition, with Attention-Deficit/Hyperactivity Disorder appearing as the primary indexed condition, and to 2 interventions — of which Placebo is the first listed. Interventions can include drugs, devices, procedures, behavioral programs, or observational arms, and each is tracked as a separate registry field so that downstream queries can filter accurately. When a trial lists multiple interventions, it usually reflects a multi-arm design or a comparison protocol rather than a single treatment being tested in isolation. The brief summary published in the registry is the clearest source of protocol intent and should be read before drawing conclusions from any sidebar tags.
Geographic footprint matters for practical reasons: NCT04781140 reports 20 study locations spanning 6 distinct geographic areas — top geographies include Florida, Georgia, California. A larger site network tends to correlate with broader recruitment capacity, but it does not imply anything about study quality, and site-level enrollment status can diverge from the overall registry status shown above. Every data point on this page comes from the public ClinicalTrials.gov dataset and is reproduced here for reference only; it is not a medical recommendation, an endorsement of the sponsor, or an invitation to enroll. Verify current status, eligibility criteria, and contact details directly at ClinicalTrials.gov, and discuss any participation decision with your own healthcare provider.
Frequently Asked Questions
What is clinical trial NCT04781140 about?
NCT04781140 is a clinical study titled "Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD". This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.
What is the current status of trial NCT04781140?
This trial is currently recruiting. It is a Phase 4 study. The enrollment target is 286 participants. The study started on 2024-03-19. Estimated completion is 2026-06.
What conditions does trial NCT04781140 study?
This clinical trial studies the following conditions: Attention-Deficit/Hyperactivity Disorder. These conditions were identified from the trial registry and reflect the primary focus areas of the research.
What interventions are being tested in trial NCT04781140?
The interventions under investigation include: Placebo (DRUG), 100mg SPN-812 (DRUG). Each intervention is being evaluated for safety and efficacy as part of this clinical study.
Who is sponsoring clinical trial NCT04781140?
This trial is sponsored by Supernus Pharmaceuticals, which has 43 total clinical trials registered on ClinicalTrials.gov. The sponsor is responsible for the study's design, funding, and regulatory compliance.
Where is trial NCT04781140 being conducted?
This trial has 20 study locations across Alabama, Arkansas, California, Colorado, Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
Learn More About Clinical Trials
How Clinical Trials Work
Understand phases 1-4, trial design, randomization, and the informed consent process.
Patient Rights in Clinical Trials
Your rights as a participant: consent, withdrawal, privacy, and who to contact.
Finding the Right Clinical Trial
A practical guide to searching trials, understanding eligibility, and evaluating options.
All Guides
Browse our complete library of clinical trial educational resources.
Read our methodology — how this data is sourced, computed, and verified.