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NCT04781140 · ClinicalTrials.gov registry record · Phase 4
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
A Phase 4 study of Attention Deficit Hyperactivity Disorder, sponsored by Supernus Pharmaceuticals.
- Recruiting
- Registry status
- Phase 4
- Development phase
- 286
- Enrollment target
- 20
- Study locations
NCT04781140: Recruiting Phase 4 study of Attention Deficit Hyperactivity Disorder, sponsored by Supernus Pharmaceuticals.
NCT04781140 is a Phase 4 study of Attention Deficit Hyperactivity Disorder that is actively recruiting participants, run by Supernus Pharmaceuticals. The registered enrollment target is 286 participants, above the 214-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (34% higher). The trial reports 20 study locations across 6 states. According to ClinicalTrials.gov, the official US trial registry.
The verdict
NCT04781140, a Phase 4 study of Attention Deficit Hyperactivity Disorder, is actively recruiting participants, sponsored by Supernus Pharmaceuticals.
- RECRUITING
- Registry status
- Phase 4
- Development phase
- 286 participants
- Enrollment target
- 20
- Study locations
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.
Primary Outcome
The Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) consists of 18 items that correspond directly to the DSM-IV-TR criteria for ADHD. The scale is subdivided into two subscales: inattention ("IA", 9 items) and hyperactivity-impulsivity ("H/I", 9 items).The clinician rates the frequency and severity of each symptom on a 4-point Likert-type scale, where 0 = Never or rarely, 1 = Sometimes, 2 = Often, and 3 = Very often. The sum of the ratings of
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 |
What NCT04781140 shows while recruiting
NCT04781140 is an interventional study that assigns participants to a tested intervention. The registered 286 participants enrollment target is mid-sized for trials with a published cap, above the 214-participant average among 102 other Attention Deficit Hyperactivity Disorder trials with a reported enrollment target (34% higher).
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.
NCT04781140 names 20 study sites across 6 states, led by Florida, Georgia, California.
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.
What interventions are being tested in trial NCT04781140?
The interventions under investigation include: Placebo (DRUG), 100mg SPN-812 (DRUG).
Who is sponsoring clinical trial NCT04781140?
This trial is sponsored by Supernus Pharmaceuticals, which has 57 total clinical trials registered on ClinicalTrials.gov.
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
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Where NCT04781140's enrollment target sits among peer trials
286 21st of 102 higher than 82 of 102 other Attention Deficit Hyperactivity Disorder trials
participants (enrollment target), bucketed by value
Each bar is a band; taller bars hold more other Attention Deficit Hyperactivity Disorder trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.
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