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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 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, roughly in line with the 278-participant average among 13 other Attention Deficit/Hyperactivity Disorder trials with a reported enrollment target. The trial reports 20 study locations across 6 states.

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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.

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

FieldValue
Enrollment Target 286 participants
Start Date 2024-03-19
Est. Completion 2026-06
Phase Phase 4

Sponsor

Supernus Pharmaceuticals

57 total trials

What the Registry Record Tells You About NCT04781140

The ClinicalTrials.gov registry entry for NCT04781140 describes a study currently listed as recruiting, categorized as Phase 4. The registered enrollment target is 286 participants, a figure that helps gauge the scale of data the investigators plan to collect, roughly in line with the 278-participant average among 13 other Attention Deficit/Hyperactivity Disorder trials with a reported enrollment target. The listed sponsor is Supernus Pharmaceuticals, which has 57 total studies on file at ClinicalTrials.gov.

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 reports 20 study locations spanning 6 distinct geographic areas - top geographies include 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.

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Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.