Open-label Study to Evaluate Long-term Safety and Efficacy of SPN-812 (Viloxazine Extended-release Capsule)

NCT02736656 | Active Not Recruiting Phase 3

• 1 other identifier: 812P310
• Study Type: interventional
• Target: 1,400
• Locations: 1 country
• Sites: 16

Brief Summary

Open label extension, long-term multicenter study of safety and efficacy of SPN-812 in pediatric ADHD patients

Conditions

Attention-Deficit/Hyperactivity Disorder

Outcome Measures

Primary Outcomes (1)

• Incidence of adverse events

  The incidence (percentage of subjects dosed) of adverse events by System Organ Class and Preferred term by cohort

  up to 72 months

Secondary Outcomes (2)

• Trends in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV-Preschool, ADHD-RS-IV or ADHD-RS-5) Score

  up to 72 months

• Trends in Clinical Global Impression-Improvement (CGI-I) scale score

  up to 72 months

Study Arms (1)

Open-Label Treatment

EXPERIMENTAL

Cohort 'A': Pediatric subjects 6-17 years of age who completed a Phase 2 (Study 812P202) or one of four Phase 3 trials (Study 812P301-P304). Cohort 'B': Pediatric subjects 4-5 years of age who completed a Phase 4 trial.

Drug: SPN-812

Interventions

SPN-812 DRUG

Cohort 'A': Children 6-11 yrs of age take 100-400mg SPN-812 once daily by mouth and adolescents 12-17 yrs of age take 100-600mg SPN-812 once daily by mouth. Pediatric subjects in Cohort 'A' are given a choice to extend their participation in the study every 6 months for up to 72 months. Cohort 'B': Pre-school-age children 4-5 yrs of age take 100mg SPN-812 once daily by mouth. Pediatric subjects in Cohort 'B' will be treated with 100 mg SPN-812 (100 mg capsule) for up to 6 months.

Also known as: viloxazine extended-release capsules

Open-Label Treatment

Eligibility Criteria

• Age: 4 Years - 18 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may not qualify if:

• Completion of a previous blinded study of SPN-812 for the treatment of ADHD.
• Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
• Weight of at least 20 kg if 6-11 years old and at least 35 kg if 12 years or older.
• Written Informed Consent obtained from the subject's parent or legally authorized representative (LAR); and written Informed Assent obtained from the subject if appropriate; written Informed Consent obtained from the subject if he/she is 18 years old.
• Females of Childbearing Potential (FOCP) must be either sexually inactive (abstinent) or, if sexually active, must agree to use one of the following acceptable birth control methods beginning 30 days prior to the first dose, throughout the study:
• simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration
• surgically sterile male partner
• simultaneous use of male condom and diaphragm with spermicide
• established hormonal contraceptive
• Current diagnosis of significant systemic disease or of a major psychiatric or neurological disorder, including history or family history of seizures or seizure-like disorders. History of Major Depressive Disorder is allowed if the subject is free of episodes currently and for the last six months.
• Current evidence of suicidal ideation and/or behaviors (assessed with Columbia Suicide Severity Rating Scale or C-SSRS).
• Body Mass Index (BMI) greater than 95th percentile for the appropriate age and gender (according to the CDC BMI-for-Age Growth Charts for boys and girls).
• Pregnancy, breastfeeding, or refusal to practice contraception during the study for female subjects of childbearing potential (FOCP).
• Current substance or alcohol use.
• Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (16)

Woodland International Research Group

Little Rock, Arkansas, 72211, United States

Location

Alliance for Wellness dba Alliance for Research

Long Beach, California, 90807, United States

Location

MCB Clinical Research Centers, LLC

Colorado Springs, Colorado, 80910, United States

Location

Meridien Research at Florida Clinical Research Center

Bradenton, Florida, 34201, United States

Location

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

Location

Indago Research & Health Center, Inc.

Hialeah, Florida, 33012, United States

Location

Florida Clinical Research Center, LLC.

Maitland, Florida, 32751, United States

Location

Florida Clinical Research Center, LLC

Maitland, Florida, 32751, United States

Location

IPS Research

Oklahoma City, Oklahoma, 73103, United States

Location

Paradigm Research Professionals

Oklahoma City, Oklahoma, 73118, United States

Location

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119, United States

Location

CNS Healthcare

Memphis, Tennessee, 38119, United States

Location

Bayou City Research Corporation

Houston, Texas, 77006, United States

Location

Road Runner Research

San Antonio, Texas, 78258, United States

Location

Ericksen Research & Development

Clinton, Utah, 84015, United States

Location

Northwest Clinical Trials

Bellevue, Washington, 98004, United States

Location

Related Publications (1)

• Findling RL, Katic A, Liebowitz M, Waxmonsky J, Fry N, Qin P, Yarullina I, Maldonado-Cruz Z, Lieberman VR, Rubin J. Viloxazine Extended-Release Capsules in Children and Adolescents with Attention-Deficit/Hyperactivity Disorder: Results of a Long-Term, Phase 3, Open-Label Extension Trial. CNS Drugs. 2025 Nov;39(11):1157-1172. doi: 10.1007/s40263-025-01209-0. Epub 2025 Aug 13.

  PMID: 40802027 DERIVED

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jonathan Rubin, MD, MBA

  Supernus Pharmaceuticals, Inc.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 4, 2016
• First Posted: April 13, 2016
• Study Start: February 2, 2016
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: June 25, 2025

Record last verified: 2025-06

Locations

US (16)