RecruitingPhase 4NCT04781140

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD

A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of SPN-812 in Preschool-Age Children (4 to 5 Years Old) With Attention-Deficit/Hyperactivity Disorder (ADHD)

Sponsor

Supernus Pharmaceuticals, Inc.

Enrollment

286 participants

Start Date

Mar 19, 2024

Study Type

INTERVENTIONAL

Conditions

Attention Deficit Hyperactivity Disorder

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.

Eligibility

Min Age: 48 MonthsMax Age: 69 Months

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying a drug called 100mg SPN-812 and a drug called Placebo for people with attention deficit hyperactivity disorder. The study is currently recruiting participants at 47 locations. People eligible for this study include aged 48 Months to 69 Months.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG100mg SPN-812

100mg SPN-812 will be administered once daily and compared to Placebo

DRUGPlacebo

Placebo will be administered once daily

Locations(47)

The Center for Clinical Trials, Inc.

Saraland, Alabama, United States

Preferred Research Partners, Inc.

Little Rock, Arkansas, United States

Advanced Research Center (ARC), Inc.

Anaheim, California, United States

Sun Valley Research Center

Imperial, California, United States

Alliance Research

Long Beach, California, United States

IMMUNOe Research Centers

Centennial, Colorado, United States

Luna Research Center

Coral Gables, Florida, United States

Sarkis Clinical Trials

Gainesville, Florida, United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, United States

Avantis Clinical Research LLC

Miami, Florida, United States

Hope Research Network, LLC.

Miami, Florida, United States

Medical Research Group of Central Florida

Orange City, Florida, United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, United States

APG Research LLC

Orlando, Florida, United States

D&H Tamarac Research Center

Tamarac, Florida, United States

Pediatric Neurology and Epilepsy Specialists

Winter Park, Florida, United States

Advanced Discovery Research LLC

Atlanta, Georgia, United States

Clinical Integrative Research Center of Atlanta

Atlanta, Georgia, United States

CenExcel iResearch, LLC

Decatur, Georgia, United States

CenExel iResearch, LLC.

Savannah, Georgia, United States

Qualmedica Research, LLC.

Evansville, Indiana, United States

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, United States

Qualmedica Research, LLC.

Owensboro, Kentucky, United States

DelRicht Research (Touro Medical Center)

New Orleans, Louisiana, United States

DelRicht Research

Prairieville, Louisiana, United States

Kennedy Krieger Institute

Baltimore, Maryland, United States

Boston Children's Hospital

Boston, Massachusetts, United States

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, United States

Precise Research Centers

Flowood, Mississippi, United States

Clinical Research of Southern Nevada, LLC.

Las Vegas, Nevada, United States

Med Clinical Research

Irvington, New Jersey, United States

Jersey Shore University Medical Center

Neptune City, New Jersey, United States

Icahn School of Medicine at Mount Sinai

New York, New York, United States

Duke University

Durham, North Carolina, United States

Cincinnati Children's Hospital and Medical Center

Cincinnati, Ohio, United States

CincyScience

West Chester, Ohio, United States

Cyn3rgy Research

Gresham, Oregon, United States

Penn State Health Medical Group - Psychiatry and Behavioral Health

Hershey, Pennsylvania, United States

Coastal Carolina Research Center

North Charleston, South Carolina, United States

Coastal Pediatric Research

Summerville, South Carolina, United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, United States

Houston Clinical Trials, LLC.

Bellaire, Texas, United States

Javara

Dallas, Texas, United States

AIM Trials, LLC

Plano, Texas, United States

Family Psych of The Woodlands

The Woodlands, Texas, United States

Clinical Research Partners, LLC

Petersburg, Virginia, United States

Virginia Commonwealth University, Virginia Treatment Center for Children

Richmond, Virginia, United States

View Full Details on ClinicalTrials.gov

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NCT04781140

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