Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
NCT ID: NCT04781140
Last Updated: 2025-11-10
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE4
286 participants
INTERVENTIONAL
2024-03-19
2025-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Placebo
Placebo, qd
Placebo
Placebo will be administered once daily
SPN-812
SPN-812, qd
100mg SPN-812
100mg SPN-812 will be administered once daily and compared to Placebo
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
100mg SPN-812
100mg SPN-812 will be administered once daily and compared to Placebo
Placebo
Placebo will be administered once daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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).
Exclusion Criteria
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).
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).
48 Months
69 Months
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Supernus Pharmaceuticals, Inc.
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Jonathan Rubin, MD, MBA
Role: STUDY_DIRECTOR
Supernus Pharmaceuticals, Inc.
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
The Center for Clinical Trials, Inc.
Saraland, Alabama, United States
Preferred Research Partners - NWA, LLC
Fayetteville, Arkansas, United States
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States
Advanced Research Center (ARC), Inc.
Anaheim, California, United States
National Institute of Clinical Research (NICR)
Garden Grove, California, United States
Sun Valley Research Center
Imperial, California, United States
Alliance Research
Long Beach, California, United States
IMMUNOe Research Centers
Centennial, Colorado, United States
Luna Research Center
Coral Gables, Florida, United States
Sarkis Clinical Trials
Gainesville, Florida, United States
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States
Accel Research Sites-LKD CRU
Lakeland, Florida, United States
Avantis Clinical Research LLC
Miami, Florida, United States
Hope Research Network, LLC.
Miami, Florida, United States
Medical Research Group of Central Florida
Orange City, Florida, United States
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States
APG Research LLC
Orlando, Florida, United States
D&H Tamarac Research Center
Tamarac, Florida, United States
Advanced Discovery Research LLC
Atlanta, Georgia, United States
Clinical Integrative Research Center of Atlanta
Atlanta, Georgia, United States
CenExcel iResearch, LLC
Decatur, Georgia, United States
CenExel iResearch, LLC.
Savannah, Georgia, United States
Qualmedica Research, LLC.
Evansville, Indiana, United States
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States
Qualmedica Research, LLC.
Owensboro, Kentucky, United States
DelRicht Research
Baton Rouge, Louisiana, United States
DelRicht Research (Touro Medical Center)
New Orleans, Louisiana, United States
Kennedy Krieger Institute
Baltimore, Maryland, United States
Boston Children's Hospital
Boston, Massachusetts, United States
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States
Precise Research Centers
Flowood, Mississippi, United States
Clinical Research of Southern Nevada, LLC.
Las Vegas, Nevada, United States
Med Clinical Research
Irvington, New Jersey, United States
Jersey Shore University Medical Center
Neptune City, New Jersey, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Duke University
Durham, North Carolina, United States
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, United States
CincyScience
West Chester, Ohio, United States
Cyn3rgy Research
Gresham, Oregon, United States
Penn State Health Milton S. Hershey Medical Center-Investigational Drug Service Pharmacy
Hershey, Pennsylvania, United States
Coastal Carolina Research Center
North Charleston, South Carolina, United States
Coastal Pediatric Research
Summerville, South Carolina, United States
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States
Houston Clinical Trials, LLC.
Bellaire, Texas, United States
Javara
Dallas, Texas, United States
AIM Trials
Plano, Texas, United States
Family Psych of The Woodlands
The Woodlands, Texas, United States
Clinical Research Partners, LLC
Petersburg, Virginia, United States
Virginia Commonwealth University, Virginia Treatment Center for Children
Richmond, Virginia, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: backup
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: backup
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
812P401
Identifier Type: -
Identifier Source: org_study_id