NCT04781140 · Supernus Pharmaceuticals, Inc.
Evaluation of SPN-812 (Viloxazine Extended-release Capsule) in Preschool-age Children With ADHD
What this study is about
This study will evaluate the effectiveness and safety of SPN-812 (viloxazine extended release) in children 4 to 5 years of age with ADHD.
View original scientific 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.
Interventions
DRUG
100mg SPN-812
100mg SPN-812 will be administered once daily and compared to Placebo
DRUG
Placebo
Placebo will be administered once daily
Primary outcome measures
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)
Time frame: Baseline and 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.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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., preschoo
Where
- Saraland, Alabama
- Little Rock, Arkansas
- Anaheim, California
- Imperial, California
- Long Beach, California
- Centennial, Colorado
- Coral Gables, Florida
- Gainesville, Florida
- Jacksonville, Florida
- Miami, Florida
- Orange City, Florida
- Orlando, Florida
And 32 more locations — see the full list below.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Feb 18, 2026 · Source of record for eligibility and locations