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Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD | Clinical Trials | Clareo Health

COMPLETEDPHASE2

Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD

Evaluation of the Efficacy and Safety of SPN-812 (Viloxazine Extended-release Capsule) in Children With ADHD - A Double-Blind, Placebo-Controlled, Dose-Ranging Study

NCT02633527•Supernus Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

This was a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy and safety of SPN-812 (Viloxazine Extended-release Capsule) in children 6-12 years of age with ADHD.

Detailed Description

This study is a randomized, double-blind, placebo-controlled, multicenter, 5-arm, parallel-group, dose-ranging study to assess the efficacy, safety, and tolerability of SPN-812 (Viloxazine Extended-release Capsule) as monotherapy in the treatment of Attention-Deficit/Hyperactivity Disorder (ADHD) in children (6-12 years of age). Subjects are randomized in a 1:2:2:2:2 ratio to receive placebo or one of four active treatments (100 mg, 200 mg, 300 mg, or 400 mg SPN-812). The primary objective is to assess the efficacy of SPN-812 in reducing ADHD symptoms as measured by the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition (ADHD-RS-IV).

Eligibility

Age

6 - 12 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Healthy male or female subjects, 6-12 years of age, inclusive, with a diagnosis of ADHD according to the Diagnostic and Statistical Manual of Mental Disorders-IV (DSM IV), confirmed with the Mini International Neuropsychiatric Interview for Children and Adolescents (MINI-KID).
•2. ADHD-RS-IV-Parent Version: Investigator Administered and Scored score of at least 26.
•3. CGI-S score of at least 4
•4. Weight of at least 20 kg.
•5. Free of medication for the treatment of ADHD or any psychosis for at least one week prior to enrollment.

Exclusion Criteria

•1. Current or lifetime diagnosis of major depressive disorder, bipolar disorder, personality disorder, Tourette's disorder, or psychosis not otherwise specified.
•2. Currently meeting DSM-IV criteria for pervasive developmental disorder, obsessive compulsive disorder, post-traumatic stress disorder, or any other anxiety disorder as primary diagnosis.
•3. Significant systemic disease.
•4. Evidence of suicidality within the six months before Screening or at Screening.
•5. BMI greater than 95th percentile for the appropriate age and gender.
•6. Pregnancy or refusal to practice abstinence during the study for female subjects of childbearing potential (FOCP).
•7. Substance or alcohol use during the last three months.
•8. Positive urine screen for cotinine, alcohol, or drugs of abuse at Screening.

Locations (1)

Florida Clinical Research Center, LLC

Maitland, Florida, United States

Key Dates

Start Date

February 1, 2016

Primary Completion Date

July 25, 2016

Completion Date

July 25, 2016

Last Updated

October 27, 2021

Enrollment

222

ACTUAL participants

Conditions

Attention-Deficit/Hyperactivity Disorder (ADHD)

Interventions

Placebo

DRUG

100mg SPN-812

DRUG

200mg SPN-812

DRUG

300mg SPN-812

DRUG

400mg SPN-812

DRUG

The ADHD Kids´ Study for Children 9-12 Years of Age

NCT07379359

Attention-Deficit/Hyperactivity Disorder (ADHD)

View study

COMPLETEDPHASE3

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Adults With ADHD

NCT04016779

Attention-Deficit/Hyperactivity Disorder (ADHD)

View study

WITHDRAWN

A Naturalistic Prospective Study of Treatment Effectiveness for Attention-Deficit/Hyperactivity Disorder (ADHD)

NCT00323700

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 27, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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