Actively Recruiting
A Phase 4, Randomized, Double-Blind, Placebo-Controlled Study of SPN-812 in Preschool-Age Children With ADHD
Led by Supernus Pharmaceuticals, Inc. · Updated on 2026-02-18
286
Participants Needed
47
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the efficacy and safety of SPN-812 (viloxazine extended release) in children aged 4 to 5 years with Attention-Deficit/Hyperactivity Disorder (ADHD). This phase 4 study is randomized, double-blind, placebo-controlled, and involves multiple centers. It aims to assess treatment effects and tolerability in this preschool-age group with ADHD symptoms confirmed by specific diagnostic criteria. Participants will be randomly assigned to receive either 100mg of SPN-812 or a placebo once daily for 6 weeks. The study includes a screening period of up to 4 weeks to determine eligibility. The total study duration for each participant is up to 10 weeks, during which the two groups will be compared to evaluate the impact of the medication versus placebo. During the study, children will be assessed using the Attention-Deficit/Hyperactivity Disorder Rating Scale, 4th Edition, Preschool Version (ADHD-RS-IV-P) and the Clinical Global Impression scales to measure symptom severity and change. Safety and tolerability will be monitored throughout. Parents or guardians will provide consent, and children will participate in structured activities to help evaluate their symptoms outside the home. Regular study visits will include clinical evaluations and monitoring over the 6-week treatment period.
CONDITIONS
Brief Title
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or female aged 4 years 0 months to 5 years 9 months at screening and medically healthy
- Parent or legal guardian able and willing to provide written informed consent
- Primary diagnosis of ADHD by DSM-IV-TR criteria confirmed with K-SADS-PL
- ADHD-RS-IV-P Total Score ≥ 28 (males) or ≥ 24 (females) at screening and baseline
- Clinical Global Impression-Severity score ≥ 4 (moderate or worse) at screening and baseline
- Adequate non-drug treatment or symptoms severe enough to need medication
- Participating in structured group activity at least 2 days per week during study
- No new behavioral therapy started within 30 days before screening, and no planned changes during study
- If on ADHD medication, symptoms not well controlled and medication stopped at least 7 days before baseline
- No conditions that could affect assessments or increase risk
- Living with same parent(s) or under shared custody for at least 6 months prior to screening
- Body weight at or above 5th percentile for age and sex at screening and baseline
You will not qualify if you...
- Diagnosis of another primary psychiatric disorder or comorbid disorder likely to interfere with study
- Major neurological disorder or history of seizures assessed case-by-case
- Family history of Bipolar Disorder in first degree relative
- Global developmental delay or intellectual disability
- Significant systemic disease per investigator judgment
- Body mass index above 95th percentile at screening or baseline
- Blood pressure and pulse rate above 95th percentile for age and sex at screening or baseline
- Clinically significant ECG findings at screening
- Current or prior use of SPN-812 discontinued due to lack of effect or adverse reactions
- Allergic reaction, hypersensitivity, or intolerance to viloxazine
- Allergy to pudding or applesauce or inability to swallow intact capsule
- Food allergy or dietary restrictions contraindicating study participation
- Recent investigational drug use within 30 days or 5 half-lives before baseline
- Positive urine drug test at screening (except allowed stimulant medication)
- Use of prohibited medications including certain CYP1A2 substrates during screening or study
- Any reason per investigator preventing participation
- Suicidal ideation or behavior within 6 months or lifetime suicide attempt per C-SSRS at screening
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 6 weeks
Participants receive the study medication, either SPN-812 or placebo, once daily to evaluate efficacy and safety in managing ADHD symptoms.
Baseline visit and follow-up visits during treatment
Trial Site Locations
Total: 47 locations
1
The Center for Clinical Trials, Inc.
Saraland, Alabama, United States, 36571
Actively Recruiting
2
Preferred Research Partners, Inc.
Little Rock, Arkansas, United States, 72211
Actively Recruiting
3
Advanced Research Center (ARC), Inc.
Anaheim, California, United States, 92805
Actively Recruiting
4
Sun Valley Research Center
Imperial, California, United States, 92251
Actively Recruiting
5
Alliance Research
Long Beach, California, United States, 90807
Actively Recruiting
6
IMMUNOe Research Centers
Centennial, Colorado, United States, 80112
Actively Recruiting
7
Luna Research Center
Coral Gables, Florida, United States, 33134
Actively Recruiting
8
Sarkis Clinical Trials
Gainesville, Florida, United States, 32607
Actively Recruiting
9
Clinical Neuroscience Solutions, Inc.
Jacksonville, Florida, United States, 32256
Actively Recruiting
10
Avantis Clinical Research LLC
Miami, Florida, United States, 33155
Actively Recruiting
11
Hope Research Network, LLC.
Miami, Florida, United States, 33166
Actively Recruiting
12
Medical Research Group of Central Florida
Orange City, Florida, United States, 32763
Actively Recruiting
13
Clinical Neuroscience Solutions, Inc.
Orlando, Florida, United States, 32801
Actively Recruiting
14
APG Research LLC
Orlando, Florida, United States, 32803
Actively Recruiting
15
D&H Tamarac Research Center
Tamarac, Florida, United States, 33321
Actively Recruiting
16
Pediatric Neurology and Epilepsy Specialists
Winter Park, Florida, United States, 32789
Actively Recruiting
17
Advanced Discovery Research LLC
Atlanta, Georgia, United States, 30318
Actively Recruiting
18
Clinical Integrative Research Center of Atlanta
Atlanta, Georgia, United States, 30328
Actively Recruiting
19
CenExcel iResearch, LLC
Decatur, Georgia, United States, 30030
Actively Recruiting
20
CenExel iResearch, LLC.
Savannah, Georgia, United States, 31405
Actively Recruiting
21
Qualmedica Research, LLC.
Evansville, Indiana, United States, 47715
Actively Recruiting
22
Kentucky Pediatric/Adult Research
Bardstown, Kentucky, United States, 40004
Actively Recruiting
23
Qualmedica Research, LLC.
Owensboro, Kentucky, United States, 42301
Actively Recruiting
24
DelRicht Research (Touro Medical Center)
New Orleans, Louisiana, United States, 70115
Actively Recruiting
25
DelRicht Research
Prairieville, Louisiana, United States, 70769
Actively Recruiting
26
Kennedy Krieger Institute
Baltimore, Maryland, United States, 21205
Actively Recruiting
27
Boston Children's Hospital
Boston, Massachusetts, United States, 02445
Actively Recruiting
28
Neurobehavioral Medicine Group
Bloomfield Hills, Michigan, United States, 48302
Actively Recruiting
29
Precise Research Centers
Flowood, Mississippi, United States, 39232
Actively Recruiting
30
Clinical Research of Southern Nevada, LLC.
Las Vegas, Nevada, United States, 89128
Actively Recruiting
31
Med Clinical Research
Irvington, New Jersey, United States, 07111
Actively Recruiting
32
Jersey Shore University Medical Center
Neptune City, New Jersey, United States, 07753
Actively Recruiting
33
Icahn School of Medicine at Mount Sinai
New York, New York, United States, 10028
Actively Recruiting
34
Duke University
Durham, North Carolina, United States, 27705
Actively Recruiting
35
Cincinnati Children's Hospital and Medical Center
Cincinnati, Ohio, United States, 45229
Actively Recruiting
36
CincyScience
West Chester, Ohio, United States, 45069
Actively Recruiting
37
Cyn3rgy Research
Gresham, Oregon, United States, 97030
Actively Recruiting
38
Penn State Health Medical Group - Psychiatry and Behavioral Health
Hershey, Pennsylvania, United States, 17033
Actively Recruiting
39
Coastal Carolina Research Center
North Charleston, South Carolina, United States, 29405
Actively Recruiting
40
Coastal Pediatric Research
Summerville, South Carolina, United States, 29486
Actively Recruiting
41
Clinical Neuroscience Solutions, Inc.
Memphis, Tennessee, United States, 38119
Actively Recruiting
42
Houston Clinical Trials, LLC.
Bellaire, Texas, United States, 77401
Actively Recruiting
43
Javara
Dallas, Texas, United States, 75230
Actively Recruiting
44
AIM Trials, LLC
Plano, Texas, United States, 75093
Actively Recruiting
45
Family Psych of The Woodlands
The Woodlands, Texas, United States, 77381
Actively Recruiting
46
Clinical Research Partners, LLC
Petersburg, Virginia, United States, 23805
Actively Recruiting
47
Virginia Commonwealth University, Virginia Treatment Center for Children
Richmond, Virginia, United States, 23220
Actively Recruiting
Research Team
J
Joseph T Hull, PhD
L
Leslie Brijbasi
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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