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Could this pill tame ADHD in kids as young as 4?

NCT ID NCT04781140

Symptom relief Sponsor: Supernus Pharmaceuticals, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 11, 2026 · Updated 1 time

Summary

This study tests whether a medication called SPN-812 (viloxazine) can safely reduce ADHD symptoms in children aged 4 to 5. About 286 kids will receive either the drug or a placebo for 6 weeks. The goal is to see if the drug improves attention and reduces hyperactivity better than a placebo.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 286 people

The number the study aims to enrol. It can still change while the study runs.

Started

Mar 2024

Expected to finish

Jan 2028

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

48 to 69 months

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: 1. Is male or female 4 years 0 months of age to less than or equal to 5 years 9 months of age at Visit 1 (Screening) and considered medically healthy. 2. Subject's parent(s) or legal guardian(s)/representative(s) is (are) willing and able to provide written informed consent before completing any study related procedures. 3. Has a primary diagnosis of ADHD according to DSM-IV-TR criteria and confirmed with the Kiddie Schedule for Affective Disorders and Schizophrenia - Present and Lifetime Version (K-SADS-PL). 4. Has an ADHD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (females) at Visit 1 (Screening) and at Visit 2 (Baseline). 5. Has a CGI-S score of ≥ 4 (moderate or worse) at Visit 1 (Screening) and at Visit 2 (Baseline). 6. Has undergone an adequate course of non-pharmacologic treatment or is having symptoms severe enough to warrant pharmacologic treatment without prior non-pharmacologic treatment. 7. Is participating in a structured group activity (e.g., preschool, kindergarten, sports, Sunday school, summer camp or childcare program) at least 2 days a week during study so as to assess symptoms and impairment in a setting outside the home. 8. Has not initiated any behavioral intervention/therapy within 30 days of Visit 1 (Screening) and does not plan to initiate any new or discontinue any ongoing behavioral intervention/therapy during the study (e.g., subject is eligible if behavioral intervention/therapy is initiated 30 or more days prior to Visit 1 \[Screening\] and continues with a similar duration/frequency throughout their study). 9. Subjects who are on ADHD medication at Visit 1 (Screening), but whose ADHD symptoms are not well controlled on current ADHD medication (e.g., meets Inclusion Criterion #4), meet all other inclusion/exclusion criteria, and discontinues ADHD medication at least 7 days prior to the day of Visit 2 (Baseline) are eligible to participate. 10. Has no current condition in the opinion of the Investigator that could confound efficacy assessments, safety assessments or increase participant risk. 11. Has lived with the same parent(s) or legal guardian(s) or has lived under a shared living arrangement (e.g., joint legal custody) for greater than or equal to 6 months prior to Visit 1 (Screening). 12. Has a body weight ≥5th percentile for age and sex at Visit 1 (Screening) and Visit 2 (Baseline). Exclusion Criteria: 1. Has a diagnosis at Screening (per K-SADS-PL) of another psychiatric disorder that is considered to be the primary diagnosis rather than ADHD or has a comorbid psychiatric disorder secondary to ADHD that, in the opinion of the investigator (after consulting medical monitor), will likely interfere with study treatment adherence and/or impact study results. 2. Has a current diagnosis of a major neurological disorder. The eligibility of those who have seizures, a history of seizure-like events (e.g., syncope, myoclonus, severe muscle spasms), a family history of seizure disorder (immediate family, i.e., sibling, parent), and/or febrile seizures will be assessed on a case-by-case basis after consulting the medical monitor. 3. History of Bipolar Disorder diagnosed in a first degree relative. 4. Has global development delay or intellectual disability by medical history. 5. Has a current diagnosis of a significant (per Investigator's evaluation and/or judgement) systemic disease. 6. Has body mass index \> 95th percentile for the subject's age and sex at Visit 1 (Screening) or Visit 2 (Baseline). 7. Has a mean resting systolic and diastolic blood pressure\* that are both \>95th percentile for age sex, and height and has a mean resting pulse rate\* that is \>95th percentile for age and sex (males: \>117 bpm; females: \>122 bpm) at Visit 1 (Screening) or Visit 2 (Baseline). \* Note: The mean of three measurements while seated. 8. Has a clinically significant electrocardiogram finding(s) at Visit 1 (Screening). 9. Is currently taking SPN-812 for ADHD, has previously taken SPN-812 for ADHD, but discontinued due to a lack of efficacy or adverse reactions, or has history of allergic reaction, hypersensitivity or intolerance to viloxazine. 10. Has an allergy to or cannot swallow pudding and applesauce and cannot swallow intact capsule whole. 11. Has any food allergy, intolerance, restriction or special diet that, in the opinion of the Investigator, could contraindicate the subject's participation in the study. 12. Has received any investigational drug within the longer of 30 days or 5 half-lives prior to Visit 2 (e.g., first dose of study medication). 13. Has a positive urine drug test at Visit 1 (Screening). A positive test for amphetamines is allowed for subjects receiving a stimulant ADHD medication at Screening. The subject will be required to discontinue the stimulant for the duration of the study, beginning at least 7 days prior to Visit 2 (Baseline). 14. Is using of prohibited concomitant medications including known CYP1A2 substrates (e.g., theophylline, melatonin) during the Screening Period or (anticipated) for the duration of the study. 15. Any reason that, in the opinion of the Investigator, would prevent the subject from participating in the study. 16. Has suicidal ideation ("Yes" indicated on C-SSRS question 4 or 5) or suicidal behavior ("Yes" indicated on C-SSRS for any suicidal behavior) within 6 months prior to or the day of Visit 1 (Screening) or has attempted suicide ("Yes" indicated on C-SSRS for lifetime).

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Conditions

The condition(s) this trial relates to.

attention deficit hyperactivity disorder, inattentive type attention deficit-hyperactivity disorder

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Attention deficit hyperactivity disorder

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The study's own enquiry address

    This study publishes an address for enquiries. See it below .

  2. The places running it

    47 sites. The list below names each one and where it is.

  3. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  4. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • AIM Trials, LLC

    RECRUITING

    Plano, Texas, 75093, United States

    Contact Email: •••••@•••••

  • APG Research LLC

    RECRUITING

    Orlando, Florida, 32803, United States

  • Advanced Discovery Research LLC

    RECRUITING

    Atlanta, Georgia, 30318, United States

    Contact Email: •••••@•••••

  • Advanced Research Center (ARC), Inc.

    RECRUITING

    Anaheim, California, 92805, United States

    Contact Email: •••••@•••••

  • Alliance Research

    RECRUITING

    Long Beach, California, 90807, United States

    Contact Email: •••••@•••••

  • Avantis Clinical Research LLC

    RECRUITING

    Miami, Florida, 33155, United States

    Contact Email: •••••@•••••

  • Boston Children's Hospital

    RECRUITING

    Boston, Massachusetts, 02445, United States

  • CenExcel iResearch, LLC

    RECRUITING

    Decatur, Georgia, 30030, United States

  • CenExel iResearch, LLC.

    RECRUITING

    Savannah, Georgia, 31405, United States

  • Cincinnati Children's Hospital and Medical Center

    RECRUITING

    Cincinnati, Ohio, 45229, United States

    Contact Email: •••••@•••••

  • CincyScience

    RECRUITING

    West Chester, Ohio, 45069, United States

    Contact Email: •••••@•••••

  • Clinical Integrative Research Center of Atlanta

    RECRUITING

    Atlanta, Georgia, 30328, United States

  • Clinical Neuroscience Solutions, Inc.

    RECRUITING

    Jacksonville, Florida, 32256, United States

  • Clinical Neuroscience Solutions, Inc.

    RECRUITING

    Orlando, Florida, 32801, United States

    Contact Email: •••••@•••••

  • Clinical Neuroscience Solutions, Inc.

    RECRUITING

    Memphis, Tennessee, 38119, United States

  • Clinical Research Partners, LLC

    RECRUITING

    Petersburg, Virginia, 23805, United States

    Contact Email: •••••@•••••

  • Clinical Research of Southern Nevada, LLC.

    RECRUITING

    Las Vegas, Nevada, 89128, United States

  • Coastal Carolina Research Center

    RECRUITING

    North Charleston, South Carolina, 29405, United States

  • Coastal Pediatric Research

    RECRUITING

    Summerville, South Carolina, 29486, United States

    Contact Email: •••••@•••••

  • Cyn3rgy Research

    RECRUITING

    Gresham, Oregon, 97030, United States

    Contact Email: •••••@•••••

  • D&H Tamarac Research Center

    RECRUITING

    Tamarac, Florida, 33321, United States

    Contact Email: •••••@•••••

  • DelRicht Research

    RECRUITING

    Prairieville, Louisiana, 70769, United States

    Contact Email: •••••@•••••

  • DelRicht Research (Touro Medical Center)

    RECRUITING

    New Orleans, Louisiana, 70115, United States

    Contact Email: •••••@•••••

  • Duke University

    RECRUITING

    Durham, North Carolina, 27705, United States

  • Family Psych of The Woodlands

    RECRUITING

    The Woodlands, Texas, 77381, United States

    Contact Email: •••••@•••••

  • Hope Research Network, LLC.

    RECRUITING

    Miami, Florida, 33166, United States

    Contact Email: •••••@•••••

  • Houston Clinical Trials, LLC.

    RECRUITING

    Bellaire, Texas, 77401, United States

  • IMMUNOe Research Centers

    RECRUITING

    Centennial, Colorado, 80112, United States

    Contact Email: •••••@•••••

  • Icahn School of Medicine at Mount Sinai

    RECRUITING

    New York, New York, 10028, United States

  • Javara

    RECRUITING

    Dallas, Texas, 75230, United States

  • Jersey Shore University Medical Center

    RECRUITING

    Neptune City, New Jersey, 07753, United States

  • Kennedy Krieger Institute

    RECRUITING

    Baltimore, Maryland, 21205, United States

  • Kentucky Pediatric/Adult Research

    RECRUITING

    Bardstown, Kentucky, 40004, United States

  • Luna Research Center

    RECRUITING

    Coral Gables, Florida, 33134, United States

  • Med Clinical Research

    RECRUITING

    Irvington, New Jersey, 07111, United States

    Contact Email: •••••@•••••

  • Medical Research Group of Central Florida

    RECRUITING

    Orange City, Florida, 32763, United States

  • Neurobehavioral Medicine Group

    RECRUITING

    Bloomfield Hills, Michigan, 48302, United States

    Contact Email: •••••@•••••

  • Pediatric Neurology and Epilepsy Specialists

    RECRUITING

    Winter Park, Florida, 32789, United States

  • Penn State Health Medical Group - Psychiatry and Behavioral Health

    RECRUITING

    Hershey, Pennsylvania, 17033, United States

  • Precise Research Centers

    RECRUITING

    Flowood, Mississippi, 39232, United States

  • Preferred Research Partners, Inc.

    RECRUITING

    Little Rock, Arkansas, 72211, United States

    Contact Email: •••••@•••••

  • Qualmedica Research, LLC.

    RECRUITING

    Evansville, Indiana, 47715, United States

  • Qualmedica Research, LLC.

    RECRUITING

    Owensboro, Kentucky, 42301, United States

  • Sarkis Clinical Trials

    RECRUITING

    Gainesville, Florida, 32607, United States

  • Sun Valley Research Center

    RECRUITING

    Imperial, California, 92251, United States

    Contact Email: •••••@•••••

  • The Center for Clinical Trials, Inc.

    RECRUITING

    Saraland, Alabama, 36571, United States

    Contact Email: •••••@•••••

  • Virginia Commonwealth University, Virginia Treatment Center for Children

    RECRUITING

    Richmond, Virginia, 23220, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.