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

July 13, 2026 updated by: Supernus Pharmaceuticals, Inc.

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

Status

Indicates the current recruitment status or the expanded access status.
Active, not recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 who completed a randomized, double-blind, placebo-controlled clinical trial, including (A) a Phase 2 (Study 812P202: children 6 to 12 years of age) or a Phase 3 trial (Study 812P301 or 812P303: children 6 to 11 years of age; or Study 812P302 or 812P304: adolescents 12 to 17 years of age) or (B) a Phase 4 trial (Study 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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1400

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

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

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Open-Label Treatment

Cohort 'A': Children and adolescents, 6-17 years of age, who completed a Phase 2 (Study 812P202) or Phase 3 (Study 812P301, 812P302, 812P303, or 812P304) randomized, double-blind, placebo-controlled clinical trial.

Cohort 'B': Preschool-age children, 4-5 years of age, who completed a Phase 4 (Study 812P401) randomized, double-blind, placebo-controlled clinical 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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: up to 72 months
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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
Time Frame: up to 72 months
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
Time Frame: up to 72 months
CGI-I score by visit by cohort
up to 72 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Supernus Pharmaceuticals, Inc.

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Jonathan Rubin, MD, MBA, Supernus Pharmaceuticals, Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
February 2, 2016

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
September 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
September 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 4, 2016

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 7, 2016

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 13, 2016

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
July 15, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
July 13, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 812P310

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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