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Attention-Deficit/Hyperactivity DisorderPhase 3NCT02736656

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

A Phase 3 study testing SPN-812 in people with Attention-Deficit/Hyperactivity Disorder, run by Supernus Pharmaceuticals, Inc. at 16 sites in United States.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
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Trial summary

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

Who is it for?
Ages 4 to 18 years
Conditions the study is for
Attention-Deficit/Hyperactivity Disorder
What is being tested?
SPN-812
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,400 participants
Where
16 sitesUnited States
Study dates
2 Feb 2016to Sep 2026
Phase
Phase 3
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 4 to 18 years
  • All sexes
  • No healthy volunteers
  • Child, Adult

Who may be able to join

  • 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
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  • surgically sterile male partner
  • simultaneous use of male condom and diaphragm with spermicide
  • established hormonal contraceptive
  • Has completed a previous Study 812P401 and is less than 6 years of age at Visit 1 in this study (812P310).
  • Continues to be medically healthy with clinically normal laboratory profiles, vital signs, and electrocardiograms.
  • Weighs at least ≥5th percentile for age and sex.
  • Parent or LAR is willing and able to provide Written Informed Consent.

Who cannot join

  • 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.
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  • Cohort 'B' Inclusion/Exclusion Criteria:
  • Has a current diagnosis of significant systemic disease and/or of a major psychiatric or neurological disorder.
  • 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).
  • Has a BMI >95th percentile for the appropriate age and sex (according to the CDC BMI-for-Age Growth Charts for boys and girls).
  • Any reason which, in the opinion of the Investigator, would prevent the subject from participating in the study.

Trial locations and contacts

16 sites in 1 country.

16 sites in 1 country

United States16 sites

  • Northwest Clinical Trials

    Bellevue, Washington, 98004

  • Meridien Research at Florida Clinical Research Center

    Bradenton, Florida, 34201

  • Ericksen Research & Development

    Clinton, Utah, 84015

  • MCB Clinical Research Centers, LLC

    Colorado Springs, Colorado, 80910

  • Sarkis Clinical Trials

    Gainesville, Florida, 32607

  • Indago Research & Health Center, Inc.

    Hialeah, Florida, 33012

  • Bayou City Research Corporation

    Houston, Texas, 77006

  • Woodland International Research Group

    Little Rock, Arkansas, 72211

  • Alliance for Wellness dba Alliance for Research

    Long Beach, California, 90807

  • Florida Clinical Research Center, LLC.

    Maitland, Florida, 32751

  • Florida Clinical Research Center, LLC

    Maitland, Florida, 32751

  • Clinical Neuroscience Solutions, Inc.

    Memphis, Tennessee, 38119

  • CNS Healthcare

    Memphis, Tennessee, 38119

  • IPS Research

    Oklahoma City, Oklahoma, 73103

  • Paradigm Research Professionals

    Oklahoma City, Oklahoma, 73118

  • Road Runner Research

    San Antonio, Texas, 78258

Other trials in United States

About this study

Official title: 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

Read the 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).

Being tested
SPN-812
Medical subject headings
Attention Deficit Disorder with Hyperactivity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SPN-812Drug

    Also called viloxazine extended-release capsules

    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.

Study groups in NCT02736656
Study groupRoleWhat they receive
Open-Label TreatmentExperimentalCohort '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.
Receives: Drug: SPN-812

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

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

    Measured: up to 72 months

Secondary outcomes (2)

  1. 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

    Measured: up to 72 months

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

    CGI-I score by visit by cohort

    Measured: up to 72 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Apr 2016 (estimated)
  2. Study start2 Feb 2016
  3. Primary completionSep 2026 (estimated)
  4. Study completionSep 2026 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,400 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02736656
Sponsor's protocol ID
812P310
Status last verified
Jul 2026
First submitted
4 Apr 2016
Last updated
15 Jul 2026
Results posted
No

Publications

  • 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.

    PubMed 40802027

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SPN-812 in people with Attention-Deficit/Hyperactivity Disorder, run by Supernus Pharmaceuticals, Inc. at 16 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: under way, not looking for participants, as of the sponsor's last update on 15 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 16 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: up to 72 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02736656, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Jul 2026.

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