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RecruitingNCT04781140Updated Oct 5, 2026

Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD

A Phase 4 interventional study of 100mg SPN-812 and Placebo in Attention-Deficit/Hyperactivity Disorder, sponsored by Supernus Pharmaceuticals, Inc.. Recruiting at 54 sites in United States. Open to participants aged 48 Months to 69 Months. Per ClinicalTrials.gov, last updated 2026-10-05.

Sponsored by Supernus Pharmaceuticals, Inc. · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Started Mar 2024; still recruiting 2 years 6 months later.
Updated Oct 5, 2026Site recruiting status changed8 sites added+1 moreGo to Updates ↓
Phase
Phase 4
Study type
Interventional
Enrollment
286
Allocation
Randomized
Ages
48 Months to 69 Months
Sex
All
01

Study summary

This study will evaluate the efficacy and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.

Read the detailed description

This is a randomized, double-blind, placebo-controlled, multicenter, 2-arm (1:1), parallel-group, efficacy and safety/tolerability fixed-dose study of SPN-812 in preschool-age children (4 to 5 years old) with ADHD. Participants will be screened for eligibility for up to 4 weeks. Eligible participants will be treated with study medication for 6 weeks. The total duration of the study is up to 10 weeks.

02

Conditions studied

  • Attention-Deficit/Hyperactivity Disorder

Keywords

  • ADHD
03

In context

Attention Deficit Disorder with Hyperactivity

1,514 studies on the registry are indexed under Attention Deficit Disorder with Hyperactivity; 255 are open to participants now.

This study's planned enrollment of 286 is above the median of 72 across 1,207 interventional studies indexed under Attention Deficit Disorder with Hyperactivity.

Browse Attention Deficit Disorder with Hyperactivity studies →

Lead sponsor

Supernus Pharmaceuticals, Inc. is the lead sponsor of 61 studies on the registry; 6 are open to participants now.

Of its 31 completed or terminated interventional studies of FDA-regulated products, 25 (81%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
48 Months to 69 Months
Sexes eligible
All
Accepts healthy volunteers
No

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

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).
05

Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Quadruple (Participant, Care provider, Investigator, Outcomes assessor)
Enrollment
286 participants (estimated)

Study arms

  • Placebo comparator
    Placebo

    Placebo, qd

    Drug: Placebo

  • Experimental
    SPN-812

    SPN-812, qd

    Drug: 100mg SPN-812

Interventions

  • Drug100mg SPN-812

    100mg SPN-812 will be administered once daily and compared to Placebo

    Also known as: SPN-812

  • DrugPlacebo

    Placebo will be administered once daily

06

What researchers measure

Primary outcomes

  1. Change from Baseline in the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Total Score at End of Study (Week 6)

    The Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) consists of 18 items that correspond directly to the DSM-IV-TR criteria for ADHD. The scale is subdivided into two subscales: inattention ("IA", 9 items) and hyperactivity-impulsivity ("H/I", 9 items).The clinician rates the frequency and severity of each symptom on a 4-point Likert-type scale, where 0 = Never or rarely, 1 = Sometimes, 2 = Often, and 3 = Very often. The sum of the ratings of all 18 items yields the raw Total score (range: 0-54; the higher the Total score, the more severe the ADHD symptoms). Post-baseline raw Total scores are converted to a change from baseline Total score. A lower change from baseline ADHD-RS-IV-P Total Score (\<0) represents a better outcome.

    Time frame: Baseline and Week 6

Secondary outcomes

  1. Change from Baseline in the Clinical Global Impression of Severity (CGI-S) Score at End of Study (Week 6)

    The Clinical Global Impression of Severity (CGI-S) is a single item clinician-rated assessment of the severity of subject's condition (ADHD symptoms) in relation to the clinician's total experience with patients with ADHD. The CGI-S is evaluated on a 7-point scale with 1 = Normal, not at all ill, asymptomatic, 2 = Borderline Ill, 3 = Mildly Ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, and 7 = Among the most extremely ill patients (the higher the score, the more severe the overall ADHD symptoms). Post-baseline (raw) CGI-S scores are converted to a change from baseline score. A lower change from baseline CGI-S score (\<0) represents a better outcome.

    Time frame: Baseline and Week 6

  2. Clinical Global Impression of Change (CGI-C) Score at End of Study (Week 6)

    The Clinical Global Impression of Change (CGI-C) is a single item clinician-rated assessment of how much the subject's condition (ADHD) has improved, worsened or has not changed relative to his/her baseline state prior to the beginning of treatment. The CGI-C is rated on a 7-point scale from 1 to 7, where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved", 4 = "no change", 5 = "minimally worse", 6 = "much worse", and 7 = "very much worse". A CGI-C score \<4 represents a better outcome.

    Time frame: Week 6

  3. Change from Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Hyperactivity/Impulsivity Subscale Score at End of Study (Week 6)

    The Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) consists of 18 items that correspond directly to the DSM-IV-TR criteria for ADHD. The scale is subdivided into two subscales: inattention ("IA", 9 items) and hyperactivity-impulsivity ("H/I" 9 items).The clinician rates the frequency and severity of each symptom on a 4-point Likert-type scale, where 0 = Never or rarely, 1 = Sometimes, 2 = Often, and 3 = Very often. The sum of the nine H/I items yields the raw H/I subscale score (range: 0-27; the higher the H/I subscale score, the more severe the H/I symptoms). Post-baseline raw H/I subscale scores are converted to a change from baseline score. A lower change from baseline H/I subscale score (\<0) represents a better outcome.

    Time frame: Baseline and Week 6

  4. Change from Baseline in Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Inattention Subscale Score at End of Study (Week 6)

    The Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) consists of 18 items that correspond directly to the DSM-IV-TR criteria for ADHD. The scale is subdivided into two subscales: inattention ("IA", 9 items) and hyperactivity-impulsivity ("H/I" 9 items).The clinician rates the frequency and severity of each symptom on a 4-point Likert-type scale, where 0 = Never or rarely, 1 = Sometimes, 2 = Often, and 3 = Very often. The sum of the nine IA items yields the raw IA subscale score (range: 0-27; the higher the IA subscale score, the more severe the IA symptoms). Post-baseline raw IA subscale scores are converted to a change from baseline score. A lower change from baseline IA subscale score (\<0) represents a better outcome.

    Time frame: Baseline and Week 6

  5. Clinical Global Impression of Severity (CGI-S) Responder Rate (percentage of subjects with CGI-S score of 1 or 2) at End of Study (Week 6)

    The Clinical Global Impression of Severity (CGI-S) is a single item clinician-rated assessment of the severity of subject's condition (ADHD symptoms) in relation to the clinician's total experience with patients with ADHD. The CGI-S is evaluated on a 7-point scale with 1 = Normal, not at all ill, asymptomatic, 2 = Borderline Ill, 3 = Mildly Ill, 4 = Moderately Ill, 5 = Markedly Ill, 6 = Severely Ill, and 7 = Among the most extremely ill patients. The responder rate (percent) is calculated by dividing "the number of 'responders' (m)" by "the number of subjects analyzed at the respective Visit/Week (n)" and multiplying the product by 100. Responder Rate values range from 0 to 100%. A percent \>50% represents a greater number of "responders" versus "non-responders".

    Time frame: Baseline and Week 6

  6. Clinical Global Impression of Change (CGI-C) Responder Rate (percentage of subjects with CGI-C score of 1 or 2) at End of Study (Week 6)

    The Clinical Global Impression of Change (CGI-C) is a single item clinician-rated assessment of how much the subject's condition (ADHD) has improved, worsened or has not changed relative to his/her baseline state prior to the beginning of treatment. The CGI-C is rated on a 7-point scale from 1 to 7, where 1 = "very much improved", 2 = "much improved", 3 = "minimally improved", 4 = "no change", 5 = "minimally worse", 6 = "much worse", and 7 = "very much worse". The responder rate (percent) is calculated by dividing "the number of 'responders' (m)" by "the number of subjects analyzed at the respective Visit/Week (n)" and multiplying the product by 100. Responder Rate values range from 0 to 100%. A percent \>50% represents a greater number of "responders" versus "non-responders".

    Time frame: Week 6

  7. Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) Responder Rate (percentage of subjects with ≥ 50% Reduction in Change from Baseline) at End of Study (Week 6)

    The Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) consists of 18 items that correspond directly to the DSM-IV-TR criteria for ADHD. The scale is subdivided into two 9 item subscales: inattention and hyperactivity-impulsivity. The clinician rates the frequency and severity of each symptom on a 4-point Likert-type scale; 0 = Never or rarely, 1 = Sometimes, 2 = Often, and 3 = Very often. Sum of 18 ratings yields the Total score (range: 0-54; higher score represents severer symptoms). Percent reduction is calculated for the ADHD-RS-IV-P score: \[("Post-baseline"-"Baseline")/"Baseline"\] x 100; range: 0 to 100%; a "responder" is a subject with a 50% or greater reduction in change from baseline Total score. Responder rate (percent of responders) is calculated: \["number of 'responders' (m)"/ "number of subjects analyzed" (n)\] X 100; range: 0 to 100%. A Responder Rate greater than 50%, represents more "responders" versus "nonresponders".

    Time frame: Baseline and Week 6

07

Study locations

39 of 54 sites recruiting
  • The Center for Clinical Trials, Inc.
    Saraland, Alabama 36571, United States
    Recruiting
  • Preferred Research Partners-NWA, LLC
    Fayetteville, Arkansas 72703, United States
    Withdrawn
  • Preferred Research Partners, Inc.
    Little Rock, Arkansas 72211, United States
    Recruiting
  • Advanced Research Center (ARC), Inc.
    Anaheim, California 92805, United States
    Recruiting
  • Wake Research-Pharmacology Research Institute (WR-PRI), LLC [Encino]
    Encino, California 91316, United States
    Withdrawn
  • National Institute of Clinical Research (PICR)
    Garden Grove, California 92844, United States
    Terminated
  • Sun Valley Research Center
    Imperial, California 92251, United States
    Recruiting
  • Alliance Research
    Long Beach, California 90807, United States
    Recruiting
  • Wake Research-Pharmacology Research Institute (WR-PRI), LLC [Newport Beach]
    Newport Beach, California 92660, United States
    Withdrawn
  • IMMUNOe Research Centers
    Centennial, Colorado 80112, United States
    Recruiting
  • Vertex Clinical Research, LLC
    Clermont, Florida 34711, United States
    Withdrawn
  • Luna Research Center
    Coral Gables, Florida 33134, United States
    • · Contact · 305-613-7761
    Recruiting
  • Sarkis Clinical Trials
    Gainesville, Florida 32607, United States
    Terminated
  • Clinical Neuroscience Solutions, Inc.
    Jacksonville, Florida 32256, United States
    • · Contact · 904-281-5757
    Recruiting
  • Accel Research Sites - Lakeland CRU
    Lakeland, Florida 33803, United States
    Terminated
  • Avantis Clinical Research LLC
    Miami, Florida 33155, United States
    Recruiting
  • Medical Research Group of Central Florida
    Orange City, Florida 32763, United States
    • · Contact · 386-775-7627
    Recruiting
  • Clinical Neuroscience Solutions, Inc.
    Orlando, Florida 32801, United States
    Recruiting
  • APG Research LLC
    Orlando, Florida 32803, United States
    Recruiting
  • D&H Tamarac Research Center
    Tamarac, Florida 33321, United States
    Recruiting
  • Hope Research Network, LLC.
    Virginia Gardens, Florida 33166, United States
    Recruiting
  • Pediatric Neurology and Epilepsy Specialists
    Winter Park, Florida 32789, United States
    Recruiting
  • Advanced Discovery Research LLC
    Atlanta, Georgia 30318, United States
    Recruiting
  • Clinical Integrative Research Center of Atlanta
    Atlanta, Georgia 30328, United States
    • · Contact · 678-705-7341
    Recruiting
  • CenExcel iResearch, LLC
    Decatur, Georgia 30030, United States
    • · Contact · 404-537-1281
    Recruiting
  • CenExel iResearch, LLC.
    Savannah, Georgia 31405, United States
    • · Contact · 912-744-0800
    Recruiting
  • Qualmedica Research, LLC.
    Evansville, Indiana 47715, United States
    Terminated
  • Kentucky Pediatric/Adult Research
    Bardstown, Kentucky 40004, United States
    Recruiting
  • Qualmedica Research, LLC.
    Owensboro, Kentucky 42301, United States
    Terminated
  • DelRicht Research (Touro Medical Center)
    New Orleans, Louisiana 70115, United States
    Terminated
  • DelRicht Research
    Prairieville, Louisiana 70769, United States
    Recruiting
  • Kennedy Krieger Institute
    Baltimore, Maryland 21205, United States
    • · Contact · 443-923-3850
    Recruiting
  • Boston Children's Hospital
    Boston, Massachusetts 02445, United States
    Recruiting
  • Neurobehavioral Medicine Group
    Bloomfield Hills, Michigan 48302, United States
    Recruiting
  • Precise Research Centers
    Flowood, Mississippi 39232, United States
    • · Contact · 601-420-5812
    Recruiting
  • Clinical Research of Southern Nevada, LLC.
    Las Vegas, Nevada 89128, United States
    Recruiting
  • Hassman Research Institute
    Berlin, New Jersey 08009, United States
    Withdrawn
  • Med Clinical Research
    Irvington, New Jersey 07111, United States
    Recruiting
  • Jersey Shore University Medical Center
    Neptune City, New Jersey 07753, United States
    Recruiting
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10028, United States
    Withdrawn
  • Duke University
    Durham, North Carolina 27705, United States
    • · Contact · 919-681-1100
    Recruiting
  • Cincinnati Children's Hospital and Medical Center
    Cincinnati, Ohio 45229, United States
    Recruiting
  • CincyScience
    West Chester, Ohio 45069, United States
    Withdrawn
  • Cyn3rgy Research
    Gresham, Oregon 97030, United States
    Recruiting
  • Penn State Health Medical Group - Psychiatry and Behavioral Health
    Hershey, Pennsylvania 17033, United States
    Recruiting
  • Coastal Carolina Research Center
    North Charleston, South Carolina 29405, United States
    Recruiting
  • Coastal Pediatric Research
    Summerville, South Carolina 29486, United States
    Recruiting
  • Clinical Neuroscience Solutions, Inc.
    Memphis, Tennessee 38119, United States
    • · Contact · 901-843-1045
    Recruiting
  • Houston Clinical Trials, LLC.
    Bellaire, Texas 77401, United States
    Withdrawn
  • Javara
    Dallas, Texas 75230, United States
    Terminated
  • AIM Trials, LLC
    Plano, Texas 75093, United States
    Recruiting
  • Family Psych of The Woodlands
    The Woodlands, Texas 77381, United States
    Recruiting
  • Clinical Research Partners, LLC
    Petersburg, Virginia 23805, United States
    Recruiting
  • Virginia Commonwealth University, Virginia Treatment Center for Children
    Richmond, Virginia 23220, United States
    • · Contact · 804-628-8736
    Recruiting
08

Updates

1 registry update since Sep 25, 2026
Sites
8 sites added, 1 site removed. 8 sites changed recruiting status
Show 8 added (8 United States)
  • Preferred Research Partners-NWA, LLC · Fayetteville, United States
  • Wake Research-Pharmacology Research Institute (WR-PRI), LLC [Encino] · Encino, United States
  • National Institute of Clinical Research (PICR) · Garden Grove, United States
  • Wake Research-Pharmacology Research Institute (WR-PRI), LLC [Newport Beach] · Newport Beach, United States
  • Vertex Clinical Research, LLC · Clermont, United States
  • Accel Research Sites - Lakeland CRU · Lakeland, United States
  • Hope Research Network, LLC. · Virginia Gardens, United States
  • Hassman Research Institute · Berlin, United States
Show 1 removed
  • Hope Research Network, LLC. · Miami, United States
Oct 5, 2026
Show all 1 update
  1. Oct 5, 2026
    8 sites added, 1 site removed. 8 sites changed recruiting status
    Show 8 added (8 United States)
    • Preferred Research Partners-NWA, LLC · Fayetteville, United States
    • Wake Research-Pharmacology Research Institute (WR-PRI), LLC [Encino] · Encino, United States
    • National Institute of Clinical Research (PICR) · Garden Grove, United States
    • Wake Research-Pharmacology Research Institute (WR-PRI), LLC [Newport Beach] · Newport Beach, United States
    • Vertex Clinical Research, LLC · Clermont, United States
    • Accel Research Sites - Lakeland CRU · Lakeland, United States
    • Hope Research Network, LLC. · Virginia Gardens, United States
    • Hassman Research Institute · Berlin, United States
    Show 1 removed
    • Hope Research Network, LLC. · Miami, United States
    + 2 other changes: verification date and contact details

From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗

09

Registry details

Key details

Study ID
NCT04781140
Lead sponsor
Supernus Pharmaceuticals, Inc.
Responsible party
Sponsor
First posted
Mar 4, 2021
Start date
Mar 19, 2024
Primary completion
Jan 2028 (estimated)
Completion
Jan 2028 (estimated)
Last update
Oct 5, 2026

Study contacts

Olivia Elbaum
Contact
clinicaltrials@supernus.com
301-838-2500
Joseph Hull, PhD
study director · Supernus Pharmaceuticals, Inc.

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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