RECRUITING

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

Conditions

Attention-Deficit/Hyperactivity Disorder ADHD

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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

Official Title

A Phase 4, Randomized, Double-Blind, Multicenter, Placebo-Controlled, Parallel-Group Study of the Efficacy and Safety of SPN-812 in Preschool-Age Children (4 to 5 Years Old) With Attention-Deficit/Hyperactivity Disorder (ADHD)

Quick Facts

Study Start:2024-03-19

Study Completion:2025-12

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:RECRUITING

Study ID

NCT04781140

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.

Ages Eligible for Study:48 Months to 69 Months

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:CHILD

Inclusion Criteria	Exclusion Criteria
1. Is male or female between 4 years 0 months and 5 years 9 months of age at 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, including a signed Informed Consent Form and documentation of assent (if applicable) by the subject 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 Screening and at Baseline (Day 1). 5. Has a CGI-S score of ≥ 4 (moderate or worse) at Screening and at Baseline (Day 1). 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 or child care program) so as to assess symptoms and impairment in a setting outside the home. 8. Is not currently receiving a behavioral intervention for ADHD at the time of screening nor plans to receiving a behavioral intervention for ADHD throughout their study (if subject is receiving a behavioral interventions for another psychiatric disorder or disorders, their eligibility will be evaluated on a case-by-case basis). 9. For subjects who are on ADHD medication at screening, but who's ADHD symptoms are not well controlled on current ADHD medication are allowed in the study if they meet all other inclusion/exclusion criteria 10. Has no current condition in the opinion of the Investigator that could confound safety assessments or increase participant risk. 11. Has lived with the same parent(s) or legal guardian(s) for greater than or equal to 6 months. 12. Has a body weight ≥5th percentile for age and sex at Screening and Baseline.	1. Has a current diagnosis of a major psychiatric disorder. 2. Has a current diagnosis of a major neurological disorder. Subjects with seizures or with a history of seizure-like events, or with a family history of seizure disorder (immediate family, i.e., sibling, parent) are excluded. Febrile seizures are not exclusionary and will be assessed on a case-by-case basis, however, a history of complex febrile seizures is exclusionary. If for any reason the subject received medication for a febrile seizure, this will be exclusionary. 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 gender. 7. Has a resting blood pressure and heart rate\* measurement (average of the 3 'sitting' vital signs readings) greater than or equal to 95th percentile for age at screening or baseline. \* Note: The heart rate obtained during Vital Signs refers to "pulse rate". 8. Has a clinically significant electrocardiogram findings at screening. 9. Has history of allergic reaction, hypersensitivity or intolerance to viloxazine. 10. Has an allergy to applesauce or cannot swallow capsules and applesauce. 11. 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. Received any investigational drug within the longer of 30 days or 5 half-lives prior to Day 1 dosing with SM. 13. Positive drug test at 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 1 week prior to the Baseline Visit. 14. Use 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.

Inclusion Criteria

Exclusion Criteria

1. Is male or female between 4 years 0 months and 5 years 9 months of age at 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, including a signed Informed Consent Form and documentation of assent (if applicable) by the subject 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 Screening and at Baseline (Day 1).
5. Has a CGI-S score of ≥ 4 (moderate or worse) at Screening and at Baseline (Day 1).
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 or child care program) so as to assess symptoms and impairment in a setting outside the home.
8. Is not currently receiving a behavioral intervention for ADHD at the time of screening nor plans to receiving a behavioral intervention for ADHD throughout their study (if subject is receiving a behavioral interventions for another psychiatric disorder or disorders, their eligibility will be evaluated on a case-by-case basis).
9. For subjects who are on ADHD medication at screening, but who's ADHD symptoms are not well controlled on current ADHD medication are allowed in the study if they meet all other inclusion/exclusion criteria
10. Has no current condition in the opinion of the Investigator that could confound safety assessments or increase participant risk.
11. Has lived with the same parent(s) or legal guardian(s) for greater than or equal to 6 months.
12. Has a body weight ≥5th percentile for age and sex at Screening and Baseline.

1. Has a current diagnosis of a major psychiatric disorder.
2. Has a current diagnosis of a major neurological disorder. Subjects with seizures or with a history of seizure-like events, or with a family history of seizure disorder (immediate family, i.e., sibling, parent) are excluded. Febrile seizures are not exclusionary and will be assessed on a case-by-case basis, however, a history of complex febrile seizures is exclusionary. If for any reason the subject received medication for a febrile seizure, this will be exclusionary.
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 gender.
7. Has a resting blood pressure and heart rate\* measurement (average of the 3 'sitting' vital signs readings) greater than or equal to 95th percentile for age at screening or baseline. \* Note: The heart rate obtained during Vital Signs refers to "pulse rate".
8. Has a clinically significant electrocardiogram findings at screening.
9. Has history of allergic reaction, hypersensitivity or intolerance to viloxazine.
10. Has an allergy to applesauce or cannot swallow capsules and applesauce.
11. 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. Received any investigational drug within the longer of 30 days or 5 half-lives prior to Day 1 dosing with SM.
13. Positive drug test at 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 1 week prior to the Baseline Visit.
14. Use 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.

Contacts and Locations

Study Contact

Joseph T Hull, PhD

CONTACT

240-403-5324

jhull@supernus.com

Leslie Brijbasi

CONTACT

301-838-2519

lbrijbasi@supernus.com

Principal Investigator

Jonathan Rubin, MD, MBA

STUDY_DIRECTOR

Supernus Pharmaceuticals, Inc.

Study Locations (Sites)

The Center for Clinical Trials, Inc.

Saraland, Alabama, 36571

United States

Preferred Research Partners- NWA, LLC

Fayetteville, Arkansas, 72703

United States

Preferred Research Partners, Inc.

Little Rock, Arkansas, 72211

United States

Advanced Research Center, Inc.

Anaheim, California, 92805

United States

Wake Research-Pharmacology Research Institute (WR-PRI), LLC [Encino]

Encino, California, 91316

United States

National Institute of Clinical Research- Phase I Lab

Garden Grove, California, 92844

United States

Sun Valley Research Center

Imperial, California, 92251

United States

Alliance Research

Long Beach, California, 90807

United States

Wake Research-Pharmacology Research Institute (WR-PRI), LLC [Newport Beach]

Newport Beach, California, 92660

United States

Vertex Clinical Research, LLC.

Clermont, Florida, 34711

United States

Luna Research Center

Coral Gables, Florida, 33134

United States

Sarkis Clinical Trials

Gainesville, Florida, 32607

United States

Clinical Neuroscience Solutions, Inc.

Jacksonville, Florida, 32256

United States

Accel Research Sites-LKD CRU

Lakeland, Florida, 33803

United States

Avantis Clinical Research LLC

Miami, Florida, 33155

United States

Hope Research Network, LLC.

Miami, Florida, 33166

United States

Medical Research Group of Central Florida

Orange City, Florida, 32763

United States

Clinical Neuroscience Solutions, Inc.

Orlando, Florida, 32801

United States

APG Research LLC

Orlando, Florida, 32803

United States

D&H Tamarac Research Center

Tamarac, Florida, 33321

United States

Advanced Discovery Research LLC

Atlanta, Georgia, 30318

United States

Clinical Integrative Research Center of Atlanta

Atlanta, Georgia, 30328

United States

CenExcel iResearch, LLC

Decatur, Georgia, 30030

United States

Qualmedica Research, LLC.

Evansville, Indiana, 47715

United States

Kentucky Pediatric/Adult Research

Bardstown, Kentucky, 40004

United States

Qualmedica Research, LLC.

Owensboro, Kentucky, 42301

United States

DelRicht Research

Baton Rouge, Louisiana, 70115

United States

DelRicht Research (Touro Medical Center)

New Orleans, Louisiana, 70115

United States

Neurobehavioral Medicine Group

Bloomfield Hills, Michigan, 48302

United States

Clinical Research of Southern Nevada, LLC.

Las Vegas, Nevada, 89128

United States

Hassman Research Institute

Berlin, New Jersey, 08009

United States

CincyScience

West Chester, Ohio, 45069

United States

Cyn3rgy Research

Gresham, Oregon, 97030

United States

Coastal Carolina Research Center

North Charleston, South Carolina, 29405

United States

Coastal Pediatric Research

Summerville, South Carolina, 29486

United States

Clinical Neuroscience Solutions, Inc.

Memphis, Tennessee, 38119

United States

Javara

Dallas, Texas, 75230

United States

Family Psych of The Woodlands

The Woodlands, Texas, 77381

United States

Clinical Research Partners, LLC

Petersburg, Virginia, 23805

United States

Collaborators and Investigators

Sponsor: Supernus Pharmaceuticals, Inc.

Jonathan Rubin, MD, MBA, STUDY_DIRECTOR, Supernus Pharmaceuticals, Inc.

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 Registration Dates

Study Start Date2024-03-19

Study Completion Date2025-12

Study Record Updates

Study Start Date2024-03-19

Study Completion Date2025-12

Terms related to this study

Keywords Provided by Researchers

ADHD

Additional Relevant MeSH Terms

Attention-Deficit/Hyperactivity Disorder