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

Open-Label Extension Study to Evaluate the Long Term Safety and Efficacy of SPN-812 for the Treatment of Pediatric Patients With Attention-Deficit/Hyperactivity Disorder (ADHD)

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

Study Overview

• Status: Active, not recruiting
• Conditions: Attention-Deficit/Hyperactivity Disorder
• Intervention / Treatment: Drug: SPN-812

Detailed Description

This is a multicenter open-label extension study assessing long term safety and efficacy of SPN-812 (viloxazine extended-release capsules) in pediatric subjects with ADHD (A) who completed a Phase 2 (812P202: children 6 to 12 years of age) or one of four Phase 3 trials (812P301/812P303: children 6 to 11 years of age; 812P302/812P304: adolescents 12 to 17 years of age) or (B) who completed a Phase 4 trial (812P401: preschool-age children, 4-5 years of age). The study is divided into two phases, Optimization and Maintenance phases. Subjects in Cohort 'A' who completed a Phase 2 or Phase 3 trial followed protocol Schedule 'A' (exposure up to 72 months). Subjects in Cohort 'B' who complete the Phase 4 trial will follow Schedule 'B' (exposure up to 6 months).

• Study Type: Interventional
• Enrollment (Estimated): 1400
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Arkansas
    • Little Rock, Arkansas, United States, 72211
      • Woodland International Research Group
  • California
    • Long Beach, California, United States, 90807
      • Alliance for Wellness dba Alliance for Research
  • Colorado
    • Colorado Springs, Colorado, United States, 80910
      • MCB Clinical Research Centers, LLC
  • Florida
    • Bradenton, Florida, United States, 34201
      • Meridien Research at Florida Clinical Research Center
    • Gainesville, Florida, United States, 32607
      • Sarkis Clinical Trials
    • Hialeah, Florida, United States, 33012
      • Indago Research & Health Center, Inc.
    • Maitland, Florida, United States, 32751
      • Florida Clinical Research Center, LLC
    • Maitland, Florida, United States, 32751
      • Florida Clinical Research Center, LLC.
  • Oklahoma
    • Oklahoma City, Oklahoma, United States, 73118
      • Paradigm Research Professionals
    • Oklahoma City, Oklahoma, United States, 73103
      • IPS Research
  • Tennessee
    • Memphis, Tennessee, United States, 38119
      • Clinical Neuroscience Solutions, Inc.
    • Memphis, Tennessee, United States, 38119
      • CNS Healthcare
  • Texas
    • Houston, Texas, United States, 77006
      • Bayou City Research Corporation
    • San Antonio, Texas, United States, 78258
      • Road Runner Research
  • Utah
    • Clinton, Utah, United States, 84015
      • Ericksen Research & Development
  • Washington
    • Bellevue, Washington, United States, 98004
      • Northwest Clinical Trials

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 18 years (Child, Adult)
• Accepts Healthy Volunteers: No

Description

Cohort 'A' Inclusion/Exclusion Criteria:

Inclusion Criteria 'A':

1. Completion of a previous blinded study of SPN-812 for the treatment of ADHD.
2. Continues to be medically healthy and with clinically normal laboratory profiles, vital signs, and electrocardiograms (ECGs).
3. Weight of at least 20 kg if 6-11 years old and at least 35 kg if 12 years or older.
4. 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.

5. 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:

   1. simultaneous use of male condom and intra-uterine contraceptive device placed at least four weeks prior to the first study drug administration
   2. surgically sterile male partner
   3. simultaneous use of male condom and diaphragm with spermicide
   4. established hormonal contraceptive

Exclusion Criteria 'A':

1. 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.
2. Current evidence of suicidal ideation and/or behaviors (assessed with Columbia Suicide Severity Rating Scale or C-SSRS).
3. 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).
4. Pregnancy, breastfeeding, or refusal to practice contraception during the study for female subjects of childbearing potential (FOCP).
5. Current substance or alcohol use.
6. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Cohort 'B' Inclusion/Exclusion Criteria:

Inclusion Criteria 'B':

1. Has completed a previous Study 812P401 and is less than 6 years of age at Visit 1 in this study (812P310).
2. Continues to be medically healthy with clinically normal laboratory profiles, vital signs, and electrocardiograms.
3. Weighs at least ≥5th percentile for age and sex.
4. Parent or LAR is willing and able to provide Written Informed Consent.

Exclusion Criteria 'B':

1. Has a current diagnosis of significant systemic disease and/or of a major psychiatric or neurological disorder.
2. Current evidence of suicidal ideation and/or behaviors (assessed with Columbia Suicide Severity Rating Scale or C-SSRS), is at significant risk of suicide, either in the opinion of the Investigator or defined as a "yes" to suicidal ideation C-SSRS questions 4 or 5 or answering "yes" to suicidal behavior on the C-SSRS at Visit 1 or has attempted suicide from day of end of study in previous blinded study to day of Visit 1 in this study (812P310).
3. Has a BMI >95th percentile for the appropriate age and sex (according to the CDC BMI-for-Age Growth Charts for boys and girls).
4. Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Open-Label Treatment; 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; 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.; Other Names: viloxazine extended-release capsules

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Trends in Attention-Deficit/Hyperactivity Disorder Rating Scale (ADHD-RS-IV-Preschool, ADHD-RS-IV or ADHD-RS-5) Score	Change from Baseline in ADHD-RS Total score by visit by cohort	up to 72 months
Trends in Clinical Global Impression-Improvement (CGI-I) scale score	CGI-I score by visit by cohort	up to 72 months

Collaborators and Investigators

• Sponsor: Supernus Pharmaceuticals, Inc.
• Investigators: Study Director: Jonathan Rubin, MD, MBA, Supernus Pharmaceuticals, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 2, 2016
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: April 4, 2016
• First Submitted That Met QC Criteria: April 7, 2016
• First Posted (Estimated): April 13, 2016

Study Record Updates

• Last Update Posted (Estimated): June 25, 2025
• Last Update Submitted That Met QC Criteria: June 19, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neurologic Manifestations; Nervous System Diseases; Mental Disorders; Neurodevelopmental Disorders; Attention Deficit and Disruptive Behavior Disorders; Dyskinesias; Hyperkinesis; Attention Deficit Disorder with Hyperactivity; Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Neurotransmitter Agents; Membrane Transport Modulators; Psychotropic Drugs; Adrenergic Agents; Neurotransmitter Uptake Inhibitors; Antidepressive Agents; Adrenergic Uptake Inhibitors; Antidepressive Agents, Second-Generation; Viloxazine
• Other Study ID Numbers: 812P310