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

NCT04781140 | Recruiting Phase 4 FDA Drug

• 1 other identifier: 812P401
• Study Type: interventional
• Target: 286
• Locations: 1 country
• Sites: 47

Brief 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.

Conditions

Attention-Deficit/Hyperactivity Disorder

Keywords

ADHD

Outcome Measures

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.

  Baseline and Week 6

Secondary Outcomes (7)

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

  Baseline and Week 6

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

  Week 6

• 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)

  Baseline and Week 6

• 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)

  Baseline and Week 6

• 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)

  Baseline and Week 6

Study Arms (2)

Placebo

PLACEBO COMPARATOR

Placebo, qd

Drug: Placebo

SPN-812

EXPERIMENTAL

SPN-812, qd

Drug: 100mg SPN-812

Interventions

Placebo DRUG

Placebo will be administered once daily

Placebo

100mg SPN-812 DRUG

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

Also known as: SPN-812

SPN-812

Eligibility Criteria

• Age: 48 Months - 69 Months
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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.
• 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.
• 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).
• Has an ADHD-RS-IV-P Total Score of ≥ 28 (males) or ≥ 24 (females) at Visit 1 (Screening) and at Visit 2 (Baseline).
• Has a CGI-S score of ≥ 4 (moderate or worse) at Visit 1 (Screening) and at Visit 2 (Baseline).
• Has undergone an adequate course of non-pharmacologic treatment or is having symptoms severe enough to warrant pharmacologic treatment without prior non-pharmacologic treatment.
• 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.
• 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).

You may not qualify if:

• Has no current condition in the opinion of the Investigator that could confound efficacy assessments, safety assessments or increase participant risk.
• 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).
• Has a body weight ≥5th percentile for age and sex at Visit 1 (Screening) and Visit 2 (Baseline).
• 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.
• 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.
• History of Bipolar Disorder diagnosed in a first degree relative.
• Has global development delay or intellectual disability by medical history.
• Has a current diagnosis of a significant (per Investigator's evaluation and/or judgement) systemic disease.
• Has body mass index \> 95th percentile for the subject's age and sex at Visit 1 (Screening) or Visit 2 (Baseline).
• 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.
• Has a clinically significant electrocardiogram finding(s) at Visit 1 (Screening).
• 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.
• Has an allergy to or cannot swallow pudding and applesauce and cannot swallow intact capsule whole.
• 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.
• 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).

Sponsors & Collaborators

• Supernus Pharmaceuticals, Inc.: lead

Study Sites (47)

The Center for Clinical Trials, Inc.

Saraland, Alabama, 36571, United States

RECRUITING

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211, United States

RECRUITING

Advanced Research Center (ARC), Inc.

Anaheim, California, 92805, United States

RECRUITING

Sun Valley Research Center

Imperial, California, 92251, United States

RECRUITING

Alliance Research

Long Beach, California, 90807, United States

RECRUITING

IMMUNOe Research Centers

Centennial, Colorado, 80112, United States

RECRUITING

Luna Research Center

Coral Gables, Florida, 33134, United States

RECRUITING

Sarkis Clinical Trials

Gainesville, Florida, 32607, United States

RECRUITING

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256, United States

RECRUITING

Avantis Clinical Research LLC

Miami, Florida, 33155, United States

RECRUITING

Hope Research Network, LLC.

Miami, Florida, 33166, United States

RECRUITING

Medical Research Group of Central Florida

Orange City, Florida, 32763, United States

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

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

RECRUITING

CenExcel iResearch, LLC

Decatur, Georgia, 30030, United States

RECRUITING

CenExel iResearch, LLC.

Savannah, Georgia, 31405, United States

RECRUITING

Qualmedica Research, LLC.

Evansville, Indiana, 47715, United States

RECRUITING

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, 40004, United States

RECRUITING

Qualmedica Research, LLC.

Owensboro, Kentucky, 42301, United States

RECRUITING

DelRicht Research (Touro Medical Center)

New Orleans, Louisiana, 70115, United States

RECRUITING

DelRicht Research

Prairieville, Louisiana, 70769, United States

RECRUITING

Kennedy Krieger Institute

Baltimore, Maryland, 21205, United States

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

RECRUITING

Clinical Research of Southern Nevada, LLC.

Las Vegas, Nevada, 89128, United States

RECRUITING

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

RECRUITING

Duke University

Durham, North Carolina, 27705, United States

RECRUITING

Cincinnati Children's Hospital and Medical Center

Cincinnati, Ohio, 45229, United States

RECRUITING

CincyScience

West Chester, Ohio, 45069, United States

RECRUITING

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

RECRUITING

Houston Clinical Trials, LLC.

Bellaire, Texas, 77401, United States

RECRUITING

Javara

Dallas, Texas, 75230, United States

RECRUITING

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

RECRUITING

MeSH Terms

Conditions

Attention Deficit Disorder with Hyperactivity

Condition Hierarchy (Ancestors)

Attention Deficit and Disruptive Behavior Disorders; Neurodevelopmental Disorders; Mental Disorders

Study Officials

• Jonathan Rubin, MD, MBA

  Supernus Pharmaceuticals, Inc.

  STUDY DIRECTOR

Central Study Contacts

Joseph T Hull, PhD

CONTACT

240-403-5324; jhull@supernus.com

Leslie Brijbasi

CONTACT

301-838-2519; lbrijbasi@supernus.com

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 26, 2021
• First Posted: March 4, 2021
• Study Start: March 19, 2024
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: February 18, 2026

Record last verified: 2026-02

Locations

US (47)